ying qiu, phd world diabetes congress 2013 melbourne, australia

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Why Physicians Do Not Prescribe Initial Dual Therapy to Qualified T2DM Patients:

A Survey Study in the US

Ying Qiu, PhDWorld Diabetes Congress 2013

Melbourne, Australia

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Disclosure

Ying Qiu is a current employee of Merck & Co.

Qiong Li is a former employee of Merck & Co.

Ravi Shankar is a current employee of Merck & Co.

Samuel S. Engel is a current employee of Merck & Co.

AsclepiusJT LLC (Jackson Tang, Chun-Po Steve Fan, Zhiyi Li) received funding from Merck & Co.

Kantar Health Germany (Mercedes Apecechea, Ruth Hegar) received funding from Merck & Co.

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AACE/ACE recommend initial dual therapy for A1C between 7.6% and 9.0%

The AACE/ACE pharmacologic recommendations are stratified by baseline A1C:

6.5 ~ 7.5%: Initiate monotherapy

7.6 ~ 9.0%: Initiate dual therapy- Metformin based dual therapy

> 9.0%: Initiate triple therapy or initiate insulin

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In practice many physicians do not prescribe dual therapy for qualifying patients

A recent study using GE EMR database found that only 7.6% T2DM patients with an initial A1C of 7.6% to 9.0% received the recommended dual therapy within 30 days after diagnosis (Qiu et al., results presented at ADA 2012).

Many potential barriers exist preventing qualified patients from receiving the recommended treatment

‒ Barriers may be caused by physician, patient, system, and drug related reasons.

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The research objective is to better understand these barriers

What are physicians' reasons for not prescribing initial dual therapy in qualified T2DM patients per AACE/ACE guideline?

Are the reasons associated with any of the physician and patient characteristics (i.e. physicians’ specialty and patients’ age)?

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We conducted a large US-based physician survey and patient chart review

Primary care physicians (PCPs) and specialists were randomly selected to participate in a web-based survey.

Each physician provided medical chart reviews for 4 randomly selected patients who were diagnosed with A1C between 7.6% and 9.0% after Jan 1, 2010 and initiated with metformin monotherapy after diagnosis.

Physician characteristics, along with key patient characteristics and lab measures, were collected.

The final analysis sample included 1,525 physicians and 5,995 patient records.

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The physicians were asked to rate the relevance of each reason on their decisions

22 reasons on why initial metformin monotherapy was given instead of dual therapy

‒ 12 physician-related reasons (e.g. “Metformin monotherapy is sufficient to improve glycemic control”)

‒ 8 patient-related reasons (e.g. “Patient has mild hyperglycemia”)

‒ 1 system-related reason (e.g. “Insurance of the patient does not cover the dual therapy medications”

‒ 1 drug-related reason(e.g. “Long term safety profile of dual therapy is not clear”)

Physicians were asked to rate the relevance of each reason using a 5-point Likert scale:

‒ 1-Most irrelevant

‒ 2-Irrelevant

‒ 3-Neutral

‒ 4-Relevant

‒ 5-Most relevant

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The list of 22 reasons in the survey

1. Metformin monotherapy is sufficient to improve glycemic control

2. In my opinion metformin monotherapy has better efficacy compared to dual therapy

3. Monotherapy is easier to handle than dual therapy

4. I believe that monotherapy and changes in lifestyle (e.g. physical activity and dietary change) are enough for hyperglycemia control

5. I recommend monotherapy before considering dual therapy

6. I am not comfortable with dual therapies for T2DM in general

7. I am uncertain how to dose the dual therapy

8. Adjusting of dual therapy is too time consuming

9. I have concerns regarding the patient's noncompliance to the dual therapy

10. I am not aware of guidelines recommending initial dual therapy for T2DM

11. Recommendations are not clear, because there are so many of them

12. I disagree with the guideline recommendations for treating this patient

Physician-related Patient-related

1. Patient has mild hyperglycemia

2. Patient has medication intolerance for dual therapy

3. Patient has fear of side effects with dual therapy

4. Cognitive burden of administering dual therapy is too high for this patient

5. Patients attitudes toward initial dual therapy are denial, passive or unrealistic

6. Patient has a short life expectancy

7. Patient expresses that dual therapy poses a high financial burden for him/her

8. Patient´s access to care is limited (e.g. long distance to practice, need assistance for transportation)

Drug-related

1. Long term safety profile of dual therapy is not clear

System-related

1. Insurance of the patient does not cover the dual therapy medications

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Top 5 most relevant reasons (>50% answered relevant) for not initiating dual therapy

ReasonsDistribution of Responses

N=5,995Summary Statistics

Irrelevant (Score = 1, 2)

Neutral (Score = 3)

Relevant (Score = 4, 5)

mean std

Physician related reasons

1. I recommend monotherapy before considering dual therapy 14.5% 16.6% 68.9% 3.75 1.09

2. Metformin monotherapy is sufficient to improve glycemic control 17.8% 13.9% 68.3% 3.66 1.10

3. Monotherapy is easier to handle than dual therapy 19.2% 18.7% 62.1% 3.53 1.15


20.6% 21.9% 57.4% 3.47 1.12

Patient related reason

5. Patient has mild hyperglycemia 26.2% 21.1% 52.7% 3.27 1.11

Based on 5-point Likert scale, shown as both categorical and continuous variable

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4 out of 5 of the top reasons were more relevant for PCPs than specialists (1/2)

PCP patients

(N=4,940)Specialist patients

(N=1,055) P-value Mean SD Mean SD



3.81 1.06 3.43 1.19 <.001


3.70 1.08 3.51 1.16 <.001


3.59 1.14 3.25 1.19 <.001


3.52 1.10 3.21 1.17 <.001


5. Patient has mild hyperglycemia 3.26 1.11 3.31 1.09 0.275

Based on 5-point Likert scale, shown as continuous variable

More PCPs responded relevant (i.e. higher value) than Specialists

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4 out of 5 of the top reasons were more relevant for PCPs than specialists (2/2)

Based on 5-point Likert scale, shown as categorical variable

PCP patients (N=4,940)Specialist patients

(N=1,055)Overall P-valueN % N %

Physician related reasons1. I recommend monotherapy before considering dual therapy 3.81 1.06 3.43 1.19 <0.01Irrelevant 617 12.5% 251 23.8%Neutral 791 16.0% 203 19.2%Relevant 3,532 71.5% 601 57.0%

2. Metformin monotherapy is sufficient to improve glycemic control 3.70 1.08 3.51 1.16 <0.01Irrelevant 817 16.5% 250 23.7%Neutral 686 13.9% 146 13.8%Relevant 3,437 69.6% 659 62.5%

3. Monotherapy is easier to handle than dual therapy 3.59 1.14 3.25 1.19 <0.01Irrelevant 854 17.3% 296 28.1%Neutral 911 18.4% 213 20.2%Relevant 3,175 64.3% 546 51.8%

4. I believe that monotherapy and changes in lifestyle (e.g. physical activity and dietary change) are enough for hyperglycemia control 3.52 1.10 3.21 1.17 <0.01Irrelevant 932 18.9% 305 28.9%Neutral 1,072 21.7% 243 23.0%Relevant 2,936 59.4% 507 48.1%

Patient related reasons5. Patient has mild hyperglycemia 3.26 1.11 3.31 1.09 0.402Irrelevant 1,311 26.5% 259 24.5%Neutral 1,039 21.0% 225 21.3%Relevant 2,590 52.4% 571 54.1%

A higher percentage of PCPs responded relevant than Specialists

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Young patients

(18 - 64)(N=3,009)

Elderly patients (65+)

(N=2,986) P-value

Mean SD Mean SD



3.84 1.04 3.65 1.13 <.001


3.74 1.04 3.59 1.14 <.001


3.57 1.13 3.48 1.18 0.007


3.50 1.09 3.43 1.15 0.039


5. Patient has mild hyperglycemia 3.24 1.11 3.30 1.10 0.061

… and 4 out of 5 of the top reasons were more relevant for young patients (1/2)

Based on 5-point Likert scale, shown as continuous variable

4 out of 5 of the top reasons were more relevant for young patients

Whereas mild hyperglycemia was more relevant in elderly patients for not initiating dual therapy

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… and 4 out of 5 of the top reasons were more relevant for young patients (1/2)

Based on 5-point Likert scale, shown as categorical variable

Young patients (18 – 64) (N=3,009)

Elderly patients (65+)(N=2,986)

Overall P-valueN % N %

Physician related reasons1. I recommend monotherapy before considering dual therapy 3.81 1.06 3.43 1.19 <0.01Irrelevant 362 12.0% 506 16.9%Neutral 479 15.9% 515 17.2%Relevant 2,168 72.1% 1,965 65.8%

2. Metformin monotherapy is sufficient to improve glycemic control 3.70 1.08 3.51 1.16 <0.01Irrelevant 459 15.3% 608 20.4%Neutral 399 13.3% 433 14.5%Relevant 2,151 71.5% 1,945 65.1%

3. Monotherapy is easier to handle than dual therapy 3.59 1.14 3.25 1.19 <0.01Irrelevant 522 17.3% 628 21.0%Neutral 575 19.1% 549 18.4%Relevant 1,912 63.5% 1,809 60.6%

4. I believe that monotherapy and changes in lifestyle (e.g. physical activity and dietary change) are enough for hyperglycemia control 3.52 1.10 3.21 1.17 0.019Irrelevant 577 19.2% 660 22.1%Neutral 669 22.2% 646 21.6%Relevant 1,763 58.6% 1,680 56.3%

Patient related reasons5. Patient has mild hyperglycemia 3.26 1.11 3.31 1.09 0.020Irrelevant 832 27.7% 738 24.7%Neutral 606 20.1% 658 22.0%Relevant 1,571 52.2% 1,590 53.2%

Physicians responded 4 out of 5 of the top reasons as more relevant for young patients

Whereas mild hyperglycemia was more relevant in elderly patients for not initiating dual therapy

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For each of the top 5 reasons, we tested for association with physician/patient characteristics

Step 1 Linear models

To assess and estimate the associations without any adjustments of covariates and intra-physician correlation.

Step 2 Mixed linear

models

To account for the intra-physician correlation induced by the hierarchical data structure, we included 2 physician-specific random effects.

• Random intercepts: to account for physicians may have different understandings in each question.

• Random slope for patient’s age: to account for physicians may have different clinical interpretations of patients’ age.

Dependent variable: 5-point Likert response, as continuous variables Independent variables: Physician specialty, Patient age group

Dependent variable: 5-point Likert response, as continuous variables Independent variables: Physician specialty, Patient age, other relevant physician and patient characteristics

Note: It is common to analyze Likert response as continuous variable in survey analysis.1,2

As a sensitivity analysis, we also treated Likert response as categorical variable and conducted Ordinal Logistic regression. The results lead to the same conclusion as the current methods

1. Hoti et al, Int J Clin Pharm 20132. Raaijmakers et al. BMC Research Notes 2013

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Physician related reasons Patient related reason

I recommend monotherapy before

considering dual therapy

Metformin monotherapy is

sufficient to improve glycemic control

Monotherapy is easier to handle than

dual therapy

I believe that monotherapy and

changes in lifestyle are enough for hyperglycemia

control

Patient has mild hyperglycemia

Variable LS Mean P-value LS Mean P-value LS Mean P-value LS Mean P-value LS Mean P-value

Physician Specialty <.001 <.001 <.001 <.001 0.250

PCP 3.812 3.697 3.589 3.520 3.263

Specialists 3.432 3.511 3.249 3.205 3.306

Patient's Age <.001 <.001 0.062 0.010 0.508

Young 3.719 3.685 3.455 3.412 3.272

Elderly 3.525 3.523 3.383 3.314 3.297

Interaction terms 0.623 0.691 0.406 0.371 0.171

PCP*Elderly 3.723 3.623 3.536 3.488 3.301

PCP*Young 3.900 3.771 3.641 3.552 3.225

Specialist*Elderly 3.326 3.422 3.229 3.140 3.293

Specialist*Young 3.538 3.599 3.269 3.271 3.319

Linear model showed that PCP patients and young patients were more impacted by the physician related reasons

Result 1: From linear models

Based on 5-point Likert scale, analyzed as continuous variable

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Mixed linear model also showed PCP patients and lowering age were more impacted by the physician related reasons, after controlling for covariates and the hierarchical data structure.

Physician related reasonsPatient related

reason

I recommend monotherapy

before considering dual

therapy

Metformin monotherapy is

sufficient to improve glycemic

control

Monotherapy is easier to handle

than dual therapy

I believe that monotherapy and

changes in lifestyle are enough for

hyperglycemia control

Patient has mild hyperglycemia

Variable Estimate P-value Estimate P-value Estimate P-value Estimate P-value Estimate P-value

PCPs (vs. Specialists) 0.36 <.001 0.18 0.006 0.37 <.001 0.33 <.001 -0.06 0.296

Age (as continuous variable)

-0.06 <.001 -0.04 <.001 -0.03 <.001 -0.02 0.025 0.02 0.011

Result 2: From mixed models

Based on 5-point Likert scale, analyzed as continuous variable

Other covariates included in the mixed model:

Physician: sex, age, race, years in clinical practice, practice region, practice type, institution setting, % time spent in direct patient care, A1C as the decisive factor for the choice, treatment guidelines followed, and awareness of AACE guideline

Patient: sex, race, BMI, disease duration, A1C, number of comorbid conditions and if any concomitant medication uses

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Study Limitations

The findings may not be generalized to other countries. The study was motivated by AACE/ACE treatment guideline; the survey data were collected among US physicians and patients.

Concordance with AACE/ACE is assumed. However, prescribing behavior may not be perfectly correlated with physician guideline preference.

Physicians’ responses may be affected by self-perception. The physicians might not want others to perceive that they avoid dual-therapy despite the guideline’s recommendations. A desire to justify the treatment decision might have biased the results.

Physician’s difficulty remembering patient details may also be a limitation.

Although the mixed linear models accounted for the intra-physician correlation as a result of the hierarchical data collection, the mixed models assume no physician-patient interactions.

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Conclusion

5 reasons (4 physician-related, 1 patient related) were identified as most relevant in physicians’ decision of not initiating dual therapy for qualified patients as recommended by the treatment guideline

1. “I recommend monotherapy before considering dual therapy”

2. “Metformin monotherapy is sufficient to improve glycemic control”

3. “Monotherapy is easier to handle than dual therapy”

4. “I believe that monotherapy and changes in lifestyle (e.g. physical activity and dietary change) are enough for hyperglycemia control”

5. “Patient has mild hyperglycemia”

The reasons were much more relevant in primary care physicians than specialists and more relevant for young patients than elderly patients.

Further research in treatment patterns should be conducted to support/confirm the findings.

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Thank you!

Global Health Outcomes, Merck USA

‒ Ying Qiu, PhD; Qiong Li, PhD; Ravi Shankar, MD; Samuel S. Engel, MD

Asclepius JT, LLC

‒ Zhiyi Li; Chun-Po Steve Fan, PhD; Jackson Tang

Kantar Health Germany

‒ Mercedes Apecechea, MD; Ruth Hegar

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Appendix

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Background – AACE/ACE Diabetes Algorithm for Glycemic Control

Source: AACE COMPREHENSIVE DIABETES MANAGEMENT ALGORITHM 2013

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Survey Design – Data Collection

Physican-related

1 Metformin monotherapy is sufficient to improve glycemic control

2 In my opinion metformin monotherapy has better efficacy compared to dual therapy

3 Monotherapy is easier to handle than dual therapy

4 I believe that monotherapy and changes in lifestyle (e.g. physical activity and dietary change) are enough for hyperglycemia control

5 I recommend monotherapy before considering dual therapy

6 I am not comfortable with dual therapies for T2DM in general

7 I am uncertain how to dose the dual therapy

8 Adjusting of dual therapy is too time consuming

9 I have concerns regarding the patient's noncompliance to the dual therapy

10 I am not aware of guidelines recommending initial dual therapy for T2DM

11 Recommendations are not clear, because there are so many of them

12 I disagree with the guideline recommendations for treating this patient

Patient-related

13 Patient has mild hyperglycemia

14 Patient has medication intolerance for dual therapy

15 Patient has fear of side effects with dual therapy

16 Cognitive burden of administering dual therapy is too high for this patient

17 Patients attitudes toward initial dual therapy are denial, passive or unrealistic

18 Patient has a short life expectancy

19 Patient expresses that dual therapy poses a high financial burden for him/her

20 Patient´s access to care is limited (e.g. long distance to practice, need assistance for transportation)

Drug-related

21 Long term safety profile of dual therapy is not clear

System-related

22 Insurance of the patient does not cover the dual therapy medications

22 reasons on why initial MM was given instead of dual therapy

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Why initial MM was given instead of dual therapy (n=5,995)

Reasons for initiation of metformin monotherapySummary Response distribution

Mean Std Irrelevant Neutral RelevantPhysician relatedMetformin monotherapy is sufficient to improve glycemic control 3.66 1.10 17.8% 13.9% 68.3%In my opinion metformin monotherapy has better efficacy compared to dual therapy 2.69 1.19 46.6% 24.8% 28.5%Monotherapy is easier to handle than dual therapy 3.53 1.15 19.2% 18.7% 62.1%

I believe that monotherapy and changes in lifestyle (e.g. physical activity and dietary change) are enough for hyperglycemia control

3.47 1.12 20.6% 21.9% 57.4%

I recommend monotherapy before considering dual therapy 3.75 1.09 14.5% 16.6% 68.9%I am not comfortable with dual therapies for T2DM in general 2.04 1.17 70.1% 14.2% 15.7%I am uncertain how to dose the dual therapy 1.81 1.06 77.1% 12.7% 10.2%Adjusting of dual therapy is too time consuming 1.97 1.09 71.2% 16.3% 12.5%I have concerns regarding the patient's noncompliance to the dual therapy 2.61 1.27 48.6% 21.0% 30.3%I am not aware of guidelines recommending initial dual therapy for T2DM 2.02 1.11 68.1% 19.5% 12.4%Recommendations are not clear, because there are so many of them 2.18 1.13 61.2% 23.5% 15.3%I disagree with the guideline recommendations for treating this patient 2.15 1.09 61.1% 27.3% 11.6%

Patient relatedPatient has mild hyperglycemia 3.27 1.11 26.2% 21.1% 52.7%Patient has medication intolerance for dual therapy 2.45 1.20 55.1% 21.0% 23.9%Patient has fear of side effects with dual therapy 2.74 1.26 44.5% 20.1% 35.4%Cognitive burden of administering dual therapy is too high for this patient 2.51 1.23 52.5% 21.7% 25.8%Patients attitudes toward initial dual therapy are denial, passive or unrealistic 2.60 1.21 48.0% 24.4% 27.6%Patient has a short life expectancy 2.16 1.20 63.1% 19.5% 17.4%Patient expresses that dual therapy poses a high financial burden for him/her 2.75 1.29 44.0% 20.7% 35.3%

Patient´s access to care is limited (e.g. long distance to practice, need assistance for transportation)

2.37 1.23 56.8% 20.3% 22.9%

Drug relatedLong term safety profile of dual therapy is not clear 2.25 1.13 59.6% 24.2% 16.2%

System relatedInsurance of the patient does not cover the dual therapy medications 2.51 1.26 51.5% 22.3% 26.2%

Based on 5-point Likert scale

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PCPs SpecialistsReasons for initiation of metformin monotherapy Mean Std Mean Std P-valuePhysician related reasonsMetformin monotherapy is sufficient to improve glycemic control 3.70 1.08 3.51 1.16 <.0001In my opinion metformin monotherapy has better efficacy compared to dual therapy 2.73 1.19 2.50 1.19 <.0001Monotherapy is easier to handle than dual therapy 3.59 1.14 3.25 1.19 <.0001

I believe that monotherapy and changes in lifestyle (e.g. physical activity and dietary change) are enough for hyperglycemia control 3.52 1.10 3.21 1.17 <.0001I recommend monotherapy before considering dual therapy 3.81 1.06 3.43 1.19 <.0001I am not comfortable with dual therapies for T2DM in general 2.05 1.17 1.98 1.17 0.0311I am uncertain how to dose the dual therapy 1.82 1.06 1.75 1.05 0.0121Adjusting of dual therapy is too time consuming 1.98 1.09 1.93 1.08 0.0890I have concerns regarding the patient's noncompliance to the dual therapy 2.63 1.28 2.51 1.22 0.0129I am not aware of guidelines recommending initial dual therapy for T2DM 2.04 1.11 1.89 1.11 <.0001Recommendations are not clear, because there are so many of them 2.20 1.12 2.07 1.16 <.0001I disagree with the guideline recommendations for treating this patient 2.15 1.08 2.10 1.11 0.0891

Patient related reasonsPatient has mild hyperglycemia 3.26 1.11 3.31 1.09 0.2751Patient has medication intolerance for dual therapy 2.45 1.21 2.44 1.19 0.8132Patient has fear of side effects with dual therapy 2.74 1.26 2.74 1.26 0.9158Cognitive burden of administering dual therapy is too high for this patient 2.52 1.24 2.45 1.20 0.1489Patients attitudes toward initial dual therapy are denial, passive or unrealistic 2.61 1.22 2.56 1.19 0.3353Patient has a short life expectancy 2.14 1.19 2.23 1.21 0.0175Patient expresses that dual therapy poses a high financial burden for him/her 2.74 1.29 2.77 1.29 0.5795

Patient´s access to care is limited (e.g. long distance to practice, need assistance for transportation) 2.36 1.23 2.45 1.23 0.0194

Drug related reasonsLong term safety profile of dual therapy is not clear 2.25 1.13 2.27 1.14 0.5785

System related reasonsInsurance of the patient does not cover the dual therapy medications 2.50 1.25 2.54 1.29 0.4092

Results – Why initial MM was given instead of dual therapy (PCPs vs. Specialist)

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Results – Why initial MM was given instead of dual therapy (Young vs. Elderly)

Physicians responded for Young patients (18 - 64)

Physicians responded for Elderly patients (65+)

Reasons for initiation of metformin monotherapy Mean Std Mean Std P-value

Physician related reasons Metformin monotherapy is sufficient to improve glycemic control 3.74 1.04 3.59 1.14 <.0001In my opinion metformin monotherapy has better efficacy compared to dual therapy 2.68 1.16 2.70 1.22 0.5241Monotherapy is easier to handle than dual therapy 3.57 1.13 3.48 1.18 0.0070I believe that monotherapy and changes in lifestyle (e.g. physical activity and dietary change) are enough for hyperglycemia control 3.50 1.09 3.43 1.15 0.0390I recommend monotherapy before considering dual therapy 3.84 1.04 3.65 1.13 <.0001I am not comfortable with dual therapies for T2DM in general 2.06 1.20 2.02 1.14 0.4622I am uncertain how to dose the dual therapy 1.79 1.06 1.83 1.05 0.0395Adjusting of dual therapy is too time consuming 1.98 1.10 1.97 1.09 0.8234I have concerns regarding the patient's noncompliance to the dual therapy 2.66 1.26 2.55 1.28 0.0010I am not aware of guidelines recommending initial dual therapy for T2DM 2.05 1.13 1.98 1.09 0.0181Recommendations are not clear, because there are so many of them 2.23 1.14 2.13 1.12 0.0002I disagree with the guideline recommendations for treating this patient 2.16 1.08 2.13 1.10 0.1273

Patient related reasons Patient has mild hyperglycemia 3.24 1.11 3.30 1.10 0.0609Patient has medication intolerance for dual therapy 2.41 1.20 2.50 1.20 0.0026Patient has fear of side effects with dual therapy 2.69 1.26 2.79 1.26 0.0028Cognitive burden of administering dual therapy is too high for this patient 2.38 1.19 2.63 1.25 <.0001Patients attitudes toward initial dual therapy are denial, passive or unrealistic 2.58 1.21 2.61 1.22 0.2938Patient has a short life expectancy 1.90 1.14 2.41 1.20 <.0001Patient expresses that dual therapy poses a high financial burden for him/her 2.71 1.29 2.79 1.29 0.0215Patient´s access to care is limited (e.g. long distance to practice, need assistance for transportation) 2.29 1.22 2.46 1.24 <.0001

Drug related reasons Long term safety profile of dual therapy is not clear 2.24 1.12 2.27 1.14 0.4248

System related reasons Insurance of the patient does not cover the dual therapy medications 2.48 1.27 2.53 1.25 0.0845

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N %Medical specialtyPrimary Care Physician 1,235 81.0%Specialist 290 19.0%

Male 1,162 76.2%RaceWhite 957 62.8%Black/African American 43 2.8%Hispanic/Latino 42 2.8%Asian 446 29.2%Other 64 4.2%

Age (in years) (mean, std) 47.00 8.99Age group34 or less 105 6.9%35-44 563 36.9%45-54 492 32.3%55-64 322 21.1%65 or above 43 2.8%

Years in clinical practice (mean, std) 15.40 7.52Experience group5 years or less 119 7.8%6-10 years 345 22.6%11-15 years 396 26.0%16-20 years 266 17.4%21 or more 399 26.2%

Primary location of providing careHospital 78 5.1%Physician's office 1,032 67.7%Both 415 27.2%

N %Location of careMetropolitan 1,128 74.0%Rural 301 19.7%Other 96 6.3%

Type of practiceSolo 328 22.7%Group 1,102 76.2%Other 17 1.2%

Nurse practitioner involved Yes 509 33.4%No 1,002 65.7%Other 14 0.9%

Time spent in professional activitiesDirect patient care 95.2% 7.1%Teaching and/or Research 2.2% 4.6%Practice administration and other duties 2.7% 4.4%

Region of practiceNortheast 336 22.0%Midwest 378 24.8%South 504 33.0%West 307 20.1%

A1C as the decisive factor for the choice of monotherapy or dual therapy 1,317 86.4%Treatment guidelines followed for treating T2DM patientsAACE/ACE 654 42.9%ADA/EASD 528 34.6%Hospital/Office algorithm 113 7.4%Other 36 2.4%No guidelines 194 12.7%

Aware of AACE guideline (Among those not following AACE/ACE guidelines) 657 75.4%

Physician characteristics (n = 1,525)

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Primary Care Physician SpecialistN % N % P-value*

N 1,235 290 Male 951 77.0% 211 72.8% 0.1266RaceWhite 782 63.3% 175 60.3% 0.3457Black/African American 36 2.9% 7 2.4% 0.6427Hispanic/Latino 27 2.2% 15 5.2% 0.0052Asian 360 29.1% 86 29.7% 0.8648Other 49 4.0% 15 5.2% 0.3572

Age (in years) (mean, std) 47.19 9.01 46.20 8.89 0.0901Age group 0.244934 or less 87 7.0% 18 6.2%35-44 441 35.7% 122 42.1%45-54 404 32.7% 88 30.3%55-64 270 21.9% 52 17.9%65 or above 33 2.7% 10 3.4%

Years in clinical practice (mean, std) 15.69 7.63 14.14 6.89 0.0015Experience group 0.00305 years or less 97 7.9% 22 7.6%6-10 years 266 21.5% 79 27.2%11-15 years 313 25.3% 83 28.6%16-20 years 210 17.0% 56 19.3%21 or more 349 28.3% 50 17.2%

Primary location of providing care 0.0115Hospital 61 4.9% 17 5.9%Physician's office 857 69.4% 175 60.3%Both 317 25.7% 98 33.8%

Location of care <.0001Metropolitan 877 71.0% 251 86.6%Rural 279 22.6% 22 7.6%Other 79 6.4% 17 5.9%

Physician characteristics (PCPs vs. Specialist) (1/2)

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Primary Care Physician SpecialistN % N % P-value*

N 1,235 290 Type of practice 0.5815

Solo 272 23.2% 56 20.5%Group 889 75.7% 213 78.0%Other 13 1.1% 4 1.5%

Nurse practitioner involved <.0001Yes 364 29.5% 145 50.0%No 861 69.7% 141 48.6%Other 10 0.8% 4 1.4%

Time spent in professional activitiesDirect patient care 95.4% 7.2% 94.1% 6.7% 0.0048Teaching and/or Research 1.9% 4.6% 3.2% 4.8% <.0001Practice administration and other duties 2.6% 4.5% 2.7% 3.8% 0.7652

Region of practice 0.0015Northeast 248 20.1% 88 30.3%Midwest 320 25.9% 58 20.0%South 415 33.6% 89 30.7%West 252 20.4% 55 19.0%

A1C as the decisive factor for the choice of monotherapy or dual therapy 1,064 86.2% 253 87.2% 0.6272Treatment guidelines followed for treating T2DM patients <.0001

AACE/ACE 493 39.9% 161 55.5%ADA/EASD 441 35.7% 87 30.0%Hospital/Office algorithm 105 8.5% 8 2.8%Other 30 2.4% 6 2.1%No guidelines 166 13.4% 28 9.7%

Aware of AACE guideline (Among those not following AACE/ACE guidelines) 534 72.0% 123 95.3% <.0001

Results – Physician characteristics(PCPs vs. Specialist) (2/2)

-29--29--29-

N %Male 3,039 50.7%

Age (in years) (mean; std) 58.54 15.65

Age group

18-64 3,009 50.2%

65 or above 2,986 49.8%

Race

White 3,318 55.5%

Black/African American 1,337 22.4%

Hispanic/Latino 901 15.1%

Asian 342 5.7%

Other 106 1.8%

Not recorded 20 0.3%

Body mass index (mean; std) 31.32 6.16


Disease duration in years (mean; std) 1.61 0.81

Health status

Excellent 557 9.3%

Good 3,057 51.0%

Fair 2,091 34.9%

Poor 273 4.6%Not recorded 17 0.3%

Living situation Home with others 4,243 70.8%Home alone 1,496 25.0%

Nursing home / custodial care 155 2.6%

Other 21 0.4%


N %

Insurance status

Medicare 2,608 43.9%

Medicaid 698 11.8%

Private 2,844 47.9%

Other 87 1.5%

No insurance 174 2.9%


Previous diagnosed conditionsRetinopathy / Blindness 183 3.1%

Neuropathy 455 7.7%

Nephropathy 298 5.1%

Hypertension 3,777 64.0%

Obesity 2,713 46.0%

Dyslipidemia 3,155 53.5%

Stroke 234 4.0%

Transient ischemic attack 216 3.7%

Congestive heart failure 180 3.1%

Myocardial infarction 278 4.7%

Ischemic heart disease, including angina 267 4.5%

Peripheral artery disease 260 4.4%

Chronic renal disease / renal failure 224 3.8%

Other associated co-morbidities of diabetes

83 1.4%

None 823 14.0%


Patient characteristics (n= 5,995) (1/2)

-30--30--30-

N %

Number of comorbid conditions (mean, std)

2.09 1.51

Concomitant medication

Yes 4,320 72.1%

No 1,547 25.8%


Reason(s) for concomitant medication

Retinopathy / Blindness 50 0.8%

Neuropathy 283 4.7%

Nephropathy 188 3.2%

Hypertension 3,534 59.3%

Obesity 263 4.4%

Dyslipidemia 2,843 47.7%

Stroke 181 3.0%

Transient ischemic attack 168 2.8%

Congestive heart failure 141 2.4%

Myocardial infarction 222 3.7%

Ischemic heart disease, including angina 239 4.0%

Peripheral artery disease 158 2.6%

Chronic renal disease / renal failure 114 1.9%

Other associated co-morbidities of diabetes 56 0.9%


LAB MEASURES N %

Blood pressure (in mmhg) (mean, std)

Systolic 80.99 9.74

Diastolic 135.26 15.21


A1C (in %) (mean, std) 8.14 0.39

Fasting plasma glucose (in mg/dl) (mean, std) 167.73 46.12


2-hour postprandial glucose (in mg/dl) (mean, std) 206.22 55.14

Not recorded 4,192 69.9%

Lipid (in mg/dl) (mean, std)

Total 205.56 38.72


LDL-cholesterol 120.18 34.61


HDL-cholesterol 43.27 12.21


Triglycerides 189.03 86.33


Serum creatinine (in mg/dl) (mean, std) 1.09 0.60


EGF rate (in mL/min/1.73²) (mean, std) 69.12 20.72


Patient characteristics (n= 5,995) (2/2)

-31--31--31-

Primary Care Physician SpecialistYoung (18 - 64) Elderly (65+) Young (18 - 64) Elderly (65+)

N % N % P-value N % N % P-valueN 2,470 2,470 539 516Male 1,296 52.5% 1,221 49.4% 0.0328 284 52.7% 238 46.1% 0.0330Age (in years) (mean, std) 45.84 11.38 71.32 5.35 <.0001 45.24 11.43 72.11 5.46 <.0001RaceWhite 1,348 54.7% 1,409 57.1% 0.0889 291 54.5% 270 53.1% 0.6634Black/African American 553 22.4% 551 22.3% 0.9273 116 21.7% 117 23.0% 0.6123Hispanic/Latino 414 16.8% 307 12.4% <.0001 101 18.9% 79 15.6% 0.1512Asian 121 4.9% 161 6.5% 0.0146 23 4.3% 37 7.3% 0.0393Other 42 1.7% 53 2.1% 0.2570 5 0.9% 6 1.2% 0.6992Not recorded 5 0.2% 2 0.1% 0.2565 5 0.9% 8 1.6% 0.3594

Body mass index (mean; std) 32.48 6.25 30.35 6.22 <.0001 31.56 5.16 30.06 5.28 <.0001Not recorded 173 7.0% 181 7.3% 0.6590 47 8.7% 59 11.4% 0.1427

Disease duration in years (mean; std) 1.59 0.82 1.63 0.81 0.0908 1.57 0.82 1.66 0.80 0.0729Health status <.0001 <.0001Excellent 255 10.3% 185 7.5% 74 13.7% 43 8.3%Good 1,340 54.3% 1,197 48.5% 292 54.2% 228 44.2%Fair 782 31.7% 940 38.1% 155 28.8% 214 41.5%Poor 89 3.6% 143 5.8% 16 3.0% 25 4.8%Not recorded 4 0.2% 5 0.2% 2 0.4% 6 1.2%

Living situation <.0001 <.0001Home with others 1,899 76.9% 1,630 66.0% 393 72.9% 321 62.2%Home alone 521 21.1% 698 28.3% 130 24.1% 147 28.5%Nursing home / custodial care 12 0.5% 112 4.5% 4 0.7% 27 5.2%Other 10 0.4% 6 0.2% 1 0.2% 4 0.8%Not recorded 28 1.1% 24 1.0% 11 2.0% 17 3.3%

Patient characteristics: Young vs. Elderly by physician specialty (1/4)

-32--32--32-


N % N % P-value N % N % P-valueInsurance status

Medicare 87 3.6% 2,087 85.3% <.0001 15 2.8% 419 82.3% <.0001Medicaid 354 14.5% 252 10.3% <.0001 51 9.6% 41 8.1% 0.3946Private 1,874 76.6% 405 16.5% <.0001 454 85.0% 111 21.8% <.0001Other 36 1.5% 31 1.3% 0.5363 12 2.2% 8 1.6% 0.4265No insurance 131 5.4% 34 1.4% <.0001 8 1.5% 1 0.2% 0.0231Not recorded 24 1.0% 22 0.9% 0.7670 5 0.9% 7 1.4% 0.5113

Diabetes-related comorbiditiesRetinopathy / Blindness 34 1.4% 96 3.9% <.0001 18 3.4% 35 6.9% 0.0110Neuropathy 100 4.1% 233 9.5% <.0001 49 9.3% 73 14.5% 0.0110Nephropathy 65 2.7% 177 7.3% <.0001 15 2.9% 41 8.1% 0.0002Hypertension 1,410 58.1% 1,745 71.5% <.0001 280 53.3% 342 67.7% <.0001Obesity 1,323 54.5% 925 37.9% <.0001 281 53.5% 184 36.4% <.0001Dyslipidemia 1,230 50.7% 1,366 56.0% 0.0002 284 54.1% 275 54.5% 0.9076Stroke 21 0.9% 167 6.8% <.0001 6 1.1% 40 7.9% <.0001Transient ischemic attack 29 1.2% 153 6.3% <.0001 5 1.0% 29 5.7% <.0001Congestive heart failure 21 0.9% 123 5.0% <.0001 6 1.1% 30 5.9% <.0001Myocardial infarction 26 1.1% 193 7.9% <.0001 12 2.3% 47 9.3% <.0001Ischemic heart diseases 32 1.3% 180 7.4% <.0001 12 2.3% 43 8.5% <.0001Peripheral artery diseases 44 1.8% 169 6.9% <.0001 5 1.0% 42 8.3% <.0001Chronic renal disease / renal failure 39 1.6% 154 6.3% <.0001 2 0.4% 29 5.7% <.0001


33 1.4% 37 1.5% 0.6487 5 1.0% 8 1.6% 0.3639

None 398 16.4% 302 12.4% <.0001 74 14.1% 49 9.7% 0.0298Not recorded 44 1.8% 29 1.2% 0.0769 14 2.6% 11 2.1% 0.6192

# of comorbidities (mean; std) 1.82 1.30 2.34 1.68 <.0001 1.87 1.21 2.41 1.60 <.0001


-33--33--33-

Primary Care Physician Specialist

Young (18 - 64) Elderly (65+) Young (18 - 64) Elderly (65+)

N % N % P-value N % N % P-value

Concomitant medication <.0001 <.0001

Yes 1,626 65.8% 1,943 78.7% 352 65.3% 399 77.3%

No 797 32.3% 476 19.3% 177 32.8% 97 18.8%

Not recorded 47 1.9% 51 2.1% 10 1.9% 20 3.9%

Indications for concomitant medications

Retinopathy / Blindness 6 0.2% 33 1.3% <.0001 3 0.6% 8 1.6% 0.1114

Neuropathy 55 2.2% 158 6.4% <.0001 21 3.9% 49 9.6% 0.0002

Nephropathy 40 1.6% 116 4.7% <.0001 8 1.5% 24 4.7% 0.0027

Hypertension 1,285 52.4% 1,663 67.5% <.0001 261 48.6% 325 63.4% <.0001

Obesity 78 3.2% 135 5.5% <.0001 28 5.2% 22 4.3% 0.4814

Dyslipidemia 1,075 43.9% 1,263 51.3% <.0001 243 45.3% 262 51.1% 0.0592

Stroke 12 0.5% 138 5.6% <.0001 3 0.6% 28 5.5% <.0001

Transient ischemic attack 20 0.8% 122 5.0% <.0001 3 0.6% 23 4.5% <.0001

Congestive heart failure 14 0.6% 98 4.0% <.0001 4 0.7% 25 4.9% <.0001

Myocardial infarction 19 0.8% 159 6.5% <.0001 6 1.1% 38 7.4% <.0001

Ischemic heart disease, including angina

22 0.9% 163 6.6% <.0001 12 2.2% 42 8.2% <.0001

Peripheral artery disease 19 0.8% 110 4.5% <.0001 4 0.7% 25 4.9% <.0001

Chronic renal disease / renal failure 16 0.7% 78 3.2% <.0001 2 0.4% 18 3.5% 0.0002


22 0.9% 25 1.0% 0.6724 4 0.7% 5 1.0% 0.6864

Not recorded 19 0.8% 7 0.3% 0.0183 2 0.4% 3 0.6% 0.6190


-34--34--34-


N % N % P-value N % N % P-valueBlood pressure (in mmhg) (mean, std)

Systolic 81.31 9.00 81.08 10.21 0.5622 80.39 9.96 79.49 10.54 0.1980Diastolic 133.99 13.96 136.71 16.24 <.0001 134.02 14.02 135.58 16.36 0.2141Not recorded 48 1.9% 49 2.0% 0.9183 44 8.2% 34 6.6% 0.3287

A1C (in %) (mean, std) 8.15 0.39 8.12 0.38 0.0053 8.17 0.41 8.11 0.37 0.0777Fasting plasma glucose (in mg/dl) (mean, std)

170.28 41.24 168.05 54.04 0.0899 160.49 34.19 159.81 32.99 0.7806

Not recorded 231 9.4% 276 11.2% 0.0349 100 18.6% 109 21.1% 0.29492-hour postprandial glucose (in mg/dl) (mean; std)

209.32 65.06 203.65 49.67 0.0838 205.15 42.64 204.54 39.22 0.9190

Not recorded 1,728 70.0% 1,771 71.7% 0.1783 347 64.4% 346 67.1% 0.3601Lipid (in mg/dl) (mean; std)

Total 210.57 38.32 202.05 39.07 <.0001 205.50 35.62 196.36 38.81 0.0005Not recorded 565 22.9% 592 24.0% 0.3644 158 29.3% 195 37.8% 0.0035

LDL-cholesterol 125.48 33.23 117.47 35.32 <.0001 118.75 35.06 106.86 32.27 <.0001Not recorded 610 24.7% 597 24.2% 0.6669 177 32.8% 197 38.2% 0.0699

HDL-cholesterol 42.33 11.57 44.42 13.04 <.0001 42.46 11.52 43.12 11.05 0.1875Not recorded 631 25.5% 648 26.2% 0.5808 172 31.9% 203 39.3% 0.0117

Triglycerides 197.73 91.70 179.57 73.78 <.0001 200.35 116.37 179.62 72.92 0.0241Not recorded 671 27.2% 693 28.1% 0.4838 184 34.1% 211 40.9% 0.0235

Serum creatinine (in mg/dl) (mean; std)

1.03 0.54 1.16 0.61 <.0001 0.99 0.27 1.15 0.95 <.0001

Not recorded 231 9.4% 217 8.8% 0.4879 62 11.5% 64 12.4% 0.6522EGF rate (in mL/min/1.73²) (mean; std)

72.95 21.00 63.76 19.07 <.0001 78.72 21.58 68.09 18.95 <.0001

Not recorded 1,448 58.6% 1,443 58.4% 0.8852 354 65.7% 338 65.5% 0.9528


-35--35--35-

PCPsYoung (18 - 64) Elderly (65+)

Mean Std Mean Std P-valuePhysician related reasonsMetformin monotherapy is sufficient to improve glycemic control 3.77 1.02 3.62 1.13 <.0001In my opinion metformin monotherapy has better efficacy compared to dual therapy 2.72 1.15 2.74 1.22 0.5231Monotherapy is easier to handle than dual therapy 3.64 1.11 3.54 1.16 0.0032

I believe that monotherapy and changes in lifestyle (e.g. physical activity and dietary change) are enough for hyperglycemia control 3.55 1.07 3.49 1.13 0.0976I recommend monotherapy before considering dual therapy 3.90 1.01 3.72 1.10 <.0001I am not comfortable with dual therapies for T2DM in general 2.06 1.19 2.04 1.15 0.8570I am uncertain how to dose the dual therapy 1.80 1.06 1.84 1.05 0.0269Adjusting of dual therapy is too time consuming 1.98 1.10 1.99 1.09 0.7461I have concerns regarding the patient's noncompliance to the dual therapy 2.68 1.28 2.57 1.28 0.0027I am not aware of guidelines recommending initial dual therapy for T2DM 2.08 1.13 2.01 1.09 0.0352Recommendations are not clear, because there are so many of them 2.26 1.13 2.15 1.12 0.0007I disagree with the guideline recommendations for treating this patient 2.16 1.07 2.15 1.09 0.4466

Patient related reasonsPatient has mild hyperglycemia 3.22 1.11 3.30 1.10 0.0214Patient has medication intolerance for dual therapy 2.40 1.20 2.51 1.21 0.0017Patient has fear of side effects with dual therapy 2.69 1.26 2.80 1.27 0.0011Cognitive burden of administering dual therapy is too high for this patient 2.39 1.20 2.65 1.26 <.0001Patients attitudes toward initial dual therapy are denial, passive or unrealistic 2.59 1.22 2.62 1.22 0.2975Patient has a short life expectancy 1.88 1.13 2.40 1.20 <.0001Patient expresses that dual therapy poses a high financial burden for him/her 2.71 1.30 2.77 1.28 0.0963

Patient´s access to care is limited (e.g. long distance to practice, need assistance for transportation) 2.26 1.21 2.45 1.25 <.0001



Why initial MM was given instead of dual therapy (Among PCPs - Young vs. Elderly)

-36--36--36-

SpecialistsYoung (18 - 64) Elderly (65+)

Mean Std Mean Std P-valuePhysician related reasonsMetformin monotherapy is sufficient to improve glycemic control 3.60 1.11 3.42 1.21 0.0279In my opinion metformin monotherapy has better efficacy compared to dual therapy 2.50 1.17 2.51 1.21 0.9089Monotherapy is easier to handle than dual therapy 3.27 1.16 3.23 1.22 0.7316I believe that monotherapy and changes in lifestyle (e.g. physical activity and dietary change) are enough for hyperglycemia control 3.27 1.13 3.14 1.21 0.1159I recommend monotherapy before considering dual therapy 3.54 1.14 3.33 1.23 0.0058I am not comfortable with dual therapies for T2DM in general 2.07 1.23 1.89 1.10 0.0312I am uncertain how to dose the dual therapy 1.76 1.07 1.74 1.03 0.9216Adjusting of dual therapy is too time consuming 1.96 1.08 1.89 1.08 0.2034I have concerns regarding the patient's noncompliance to the dual therapy 2.56 1.20 2.46 1.24 0.1517I am not aware of guidelines recommending initial dual therapy for T2DM 1.94 1.14 1.84 1.08 0.2652Recommendations are not clear, because there are so many of them 2.13 1.17 2.01 1.14 0.0682I disagree with the guideline recommendations for treating this patient 2.16 1.11 2.04 1.12 0.0480

Patient related reasonsPatient has mild hyperglycemia 3.32 1.09 3.29 1.08 0.6079Patient has medication intolerance for dual therapy 2.43 1.21 2.45 1.17 0.6919Patient has fear of side effects with dual therapy 2.73 1.27 2.74 1.25 0.9374Cognitive burden of administering dual therapy is too high for this patient 2.37 1.19 2.54 1.20 0.0202Patients attitudes toward initial dual therapy are denial, passive or unrealistic 2.55 1.19 2.57 1.20 0.8265Patient has a short life expectancy 2.03 1.21 2.45 1.18 <.0001Patient expresses that dual therapy poses a high financial burden for him/her 2.69 1.26 2.84 1.31 0.0568Patient´s access to care is limited (e.g. long distance to practice, need assistance for transportation) 2.40 1.23 2.50 1.23 0.2014



Why initial MM was given instead of dual therapy (Among Specialists - Young vs. Elderly)

ying qiu, phd world diabetes congress 2013 melbourne, australia

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