toujeo ® and it’s place in therapy sharmon p. osae, pharmd richard l. roudebush va medical center...

Toujeo® and it’s Place in TherapySharmon P. Osae, PharmD

Richard L. Roudebush VA Medical Center / Purdue University

PGY-2 Ambulatory Care / Education Resident

September 17, 2015

This speaker has no actual or potential conflicts of interest to disclose in relation to this presentation

Objectives

At the end of this presentation, the participants will be able to:

Describe the national burden of diabetes on the United States

Compare and contrast insulin glargine formulations and identify recommendations regarding their use

Provide evidence-based recommendations regarding the use of Toujeo in patients with diabetes

Epidemiology

Estimated 29.1 million Americans living with diabetes mellitus (DM) Approximately 1.25 million with Type 1 DM

86 million Americans ≥20 years old with pre-diabetes

DM is the 7th leading cause of death in the United states

Centers for Disease Control and Prevention. 2014 National Diabetes Statistics Report;2014.

Toujeo®

Mechanism of ActionRegulation of glucose metabolism

Prolonged release of insulin compared to that of insulin glargine (U-100)

IndicationsImprove glycemic control in adults with type 1 and

type 2 DM

• 300 units/ml

• 1.5 ml pen

Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.

Dosing

Insulin Naïve Patients

Starting Dose of Toujeo® Frequency

Type 1 DM 0.2-0.4 units/kg/day Once Daily

Type 2 DM 0.2 units/kg/day Once Daily

Insulin Experienced Patients - Conversions

Insulin Conversion Frequency

Once daily long acting (U-100) to Toujeo®

1:1** Once Daily

Twice daily NPH to Toujeo®

Decrease total daily dose of NPH

by 20%

Once Daily

Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.

**Caveat**For patients maintained on Lantus® insulin glargine (U-100),

expect a higher daily dose requirement of Toujeo® to maintain the same level of glycemic control

Pharmacokinetics

Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.Lantus® (package insert).Sanofi-Aventis U.S. LLC;2015.

Property Toujeo® Lantus®

Onset (hours) 6 4-5

Duration of Action (hours) 24-36 24

Time to Steady State 5 days 24 hours

Adverse Effects

No difference between U-100 insulin

Hypoglycemia

Weight gain

Lipodystrophy

Hypokalemia

Injection site reactions

Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.

Clinical Data

Type 1 DM26 week open-label randomized controlled trial

Intervention• Toujeo ® once daily + bolus insulin with meals (n=273)

• Lantus ® once daily + bolus insulin with meals (n=273)

Results• Toujeo arm average A1c reduction of 0.4%

• Lantus arm average A1c reduction 0.44%

• Toujeo arm utilized 17.5% more basal insulin

• No differences in body weight

Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.Home PD et al. European Association for the Study of Diabetes Congress 2014, abstract 148.

Clinical Data

Type 2 DM26 week open-label randomized controlled study

Intervention• Toujeo once daily + bolus insulin +/- metformin (n=404)

• Lantus once daily + bolus insulin +/- metformin (n=400)

Results• Toujeo arm average A1c reduction of 0.9%

• Lantus arm average A1c reduction 0.87%

• Toujeo arm utilized 11% more basal insulin

• No differences in body weight

Toujeo® (package insert).Sanofi-Aventis U.S. LLC; 2015.Ritzel RA et al. European Association for the Study of Diabetes congress, 2014, abstract 963.

Conclusions

Toujeo® is a concentrated formulation of insulin glargine300 units/ml

Trials suggest Toujeo® is as effective as glargine in ↓ A1c ↑ Toujeo® dosages may be needed

to maintain similar glycemic control

Toujeo® and it’s Place in Therapy

Sharmon P. Osae, PharmD

Richard L. Roudebush VA Medical Center / Purdue University

PGY-2 Ambulatory Care / Education Resident

September 17, 2015