TOUCHING LIVES

ApolloHospitalsBilaspur

•• ~ ETHICS COMMllTEE~ ~11o Hospital

Seepat Road.Silaspur (C.G.)Ph.: OnS2-243300. Fax:;;:;rnS2-4 .

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To

Dr. Kalpana Dash

Apollo Hospitals, Bllaspur

Lingiadih Village, Seepat Road

Bilaspur (Chhattisgarh)

Reference NN1250-3725: An Extension to NN1250-3585 Investigating safety and efficacyof NN1250 compared to insulin detemir in subject with type 1 diabetes mellitusin a Basal! Bolus treatment regimen '. ."

',., .

Subject Approval to Conduct the study above mentioned Study in your hospital

Dear Dr. Kalpana Dash

This is with reference to your letter dated on 6 Sep, 2010 to the Committee.

Institutional Ethics Committee reviewed and discussed your application to conduct

the clinical trial entitled "NN1250-3725: An Extension to NN1250-3585

Investigating safety and efficacy of NN1250 compared to insulin detemir

in subject with type 1 diabetes mellitus in a Basall Bolus treatment

regimen" On 16 Sep, 2010 ECMeeting Date.

The following documents were reviewed:

Study code- NN1250-3725:

1. Subject Information/Informed Consent Form- English

2. Subject Diaries- English

3. Subject Identification Card- English

4. Investigators Brochure

5. eCRF Mock up

6. Glucometer usage Instructions

7. Certificate of Insurance (Global)

SeepatRoad,Bilaspur495 006 Chhatisgarh,Phone: 07752-248300-05, 414805Fax: 07752-409999Emergency IAmbulance : 1066/243310/414514

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ApolloHospitalsBilaspur

~ ~ ETHICS COMMITTEE.AYApoIlO Hospital~ Seepat Road, Bilaspur (C.G.)

Ph.: 07752-~43300, Fax: 07752-~099992.1 t:.AJ,ltA(fiI S· nn.1:~).YDate ••. 0;;1•• _. Ig ~ "J""'

8. Undertaking by Investigator

9. Reason for extension

10. Material handling and lab details

11. Consolidated Protocol including App A & B, dated: 10.May, 2010, Version 1.0,

Status Final

12. Protocol Substantial Amendment no. 1 App A & B, dated: 04.May, 2010, Version

1.0, Status Final.

13. Protocol Non-Substantial Amendment no. 1 App A & B, dated: 07.May, 2010,

Version 1.0, Status Final.

14. Subject lnformationlInformed Consent Form, Dated: 20.Jul, 2010, English- India-

Apollo Hospitals Bilaspur- Site no. 202, Version - 2.0_ IN, Status: Final.

15. Subject Information/Informed Consent form BT_Dated : 18.Aug, 2010, Hindi to

English- India- Apollo Hospitals Bilaspur- Site no. 202, Version - 2.0_ IN, Status:

Final.(Back Translation From Hindi to English)

16. Subject Information/Informed Consent Form for a Trial Subject's Female

PARTNER in case of pregnancy, Dated: 22.Jul, 2010, English- India- Apollo

Hospitals Bilaspur- Site no.: 202, Version-l.O_IN, Status: Final.

17. Subject InformationlInformed Consent Form for a Trial Subject's Female

PARTNER in case of pregnancy, Dated: 28.Jul, 2010, Hindi- India- Apollo

Hospitals Bilaspur- Site no.: 202, Version-l.O_IN, Status: Final.

18. Subject lnformationlInformed Consent Form for a Trial Subject's Female

PARTNER in case of pregnancy, Dated: 28.Jul, 2010, Hindi to English- India-

Apollo Hospitals Bilaspur- Site no.: 202, Version-l.O_IN, Status: Final. .(Back

Translation From Hindi to English)

Seepat Road,BiJaspur495 006 Chhatisgarh,Phone: 07752-248300-05, 414805Fax: 07752-409999Emergency IAmbulance: 1066/243310/414514

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11,110BOSP'TALS

TOUCHING LIVES

ApolloHospitalsBilaspur

~ ETHICS COMMRTEE.Al' AfIOIIo Hospital~ Seepat Road,ailasp\Jf (C. G.)

Ph.: G7752.2433~.F~ : 07!5~-~9999Date.Y.l?!.t'.L.aslQn~.

19. Subject Diary_English_India_ V3l, V32, V34, V36, V38, V40 & V42, Dated:

20Jul, 2010, Version-l.O_IN, Status- Final.

20. Subject Diary_English_India_ V33, V35, V37, V39, V71, V43 & V44, Dated:

20.Jul, 2010, Version-2.0_IN, Status- Final.

2l. Subject Diary_English_India_ V45 Dated: 20.Jul, 2010, Version-3.0_IN, Status-

Final.

22. Subject Diary_Hindi_India_ V31, V32, V34, V36, V38, V40 & V42, Dated:

14.Aug, 2010, Version-1.0_IN, Status- Final.

23. Subject DiaryHindiJndia , V33, V35, V37, V39, V7l, V43 & V44, Dated:

14.Aug, 2010, Version-2.0_IN, Status- Final.

24. Subject Diary_Hindi_India_ V45 Dated: 14.Aug, 2010, Version-3.0_IN, Status-

Final.

~eepatRoad,Bilaspur 495006 Chhatisgarh,Phone: 07752-248300-05, 414805Fax: 07752-409999Emergency IAmbulance: 1066/243310/414514

,~i~,'~Apollo fA~ETHICS COMMllTEEIIJ • ApOllo Hospital .)(""0110 Hospitals See,at Road, Bilaspur (C. G.)eOSPITALS Bilaspur Ph.: 07752-~4331O,Fax: On52-4~99

_TO_UC_' "_'N_O _"V_E_S Date¥.lai.f.l~Sign~;'

.The following members of the ethics committee were present at the meeting held

on 16 sep, 2010 at 12:30 pm Apollo Hospitals Bilaspur (C.G)

Title (e.g.Head, Dept.of_; Socialworker, Affiliation (Name of Institute!

Name and Role Lawver) Organization, or None)Dr P Khapre Scientific Medical Director, Railway( Chairman) (M.D.)

Dr.S.K Mohanty Scientific CIMS, Bilaspur(MS) Prof & HOD Surgery

Mr Prashant Jayaswal Senior Chhattisgarh High Court,Advocate Bilaspur

Dr (Brig.) S. K. Sharma Scientific COO cum OMS, Apollo,(MS) Hospitals, Bilaspur

Dr Sunil Sharma Scientific Sr. Consultant, Neurosurgery,(MS, MCh) Apollo Hospitals, Bilaspur

Dr A Jayavelu Scientific Sr. Consultant, Neurology,( Secretary ) (MD, OM) Apollo Hospitals, BilaspurMr. Sanjay Agrawal Non- Medical Social Worker

ScientificScientific Sr. Consultant, ENT, Apollo

Dr P P Misra (MS, FRCS) Hospitals, BilaspurDr Sushree Parida Scientific Sr. Consultant, Oncology,

(MD, OM) Apollo Hospitals, BilaspurDr Rashmi Sharma Scientific Sr. Consultant, Obstetrics and

(MS, Gynaecology, ApolloMRCOG) Hospitals, Bilaspur

Dr. P. K. Panda Scientific Sr. Consultant, Microbiology,(M.D.) Apollo Hospitals, Bilaspur

Ms.Indu Non- CEO Secretary, Apolloscientific Hospitals, Bilaspur

Seepat Road,Bilaspur495 006 Chhatisgarh.Phone: 07752-248300-05,414805Fax: 07752-409999Emergency IAmbulance : 1066/243310/414514

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Ph.: 0775~;J2J:~A':>'Sign•.•..•h.·:~Dateo. r..F'JIr.... (AM-"

We approve the trial to be conducted in its presented form under your direction atApollo Hospitals Bilaspur (C.G)

We have noted that the biological samples from study patients participating in thestudy will be sent to the central laboratory for antibody analysis as required by theprotocol and the Ethics Committee does not have any objection to the same.

Institutional Ethics Committee expects to be informed about the progress of thestudy, any SAE occurring in the course of the study, any changes in the protocol andSubject Information / Informed Consent and study related documents and asks to beinformed of study completion and / or withdrawal reasons. The committee also asksto be provided a copy of the final report. We have noted that neither you nor any ofyour proposed study team members were not present during the decision makingprocedures of the Ethics Committee.

It is confirmed that our Ethics Committee is constituted and function as per ICH-GCPguidelines and Good clinical practice guidelines issued by the Central drug standardscontrol organization and ethical guidelines for Biomedical Research on humansubjects, issued by the Indian Council of Medical Research.

Yours sincerely,

,/'/J ~ ~tr(j\fJJ;IVJ ~ ~ \(> t\\

Member ecretarv/Authorlzed signatory as per working procedure Ethics

Committee.

Member SecretaryEthics Committee

Ape". Hospital, Bilaspur (C.G.)

Seepat Road,BiJaspur495006Chhatisgarh,Phone: 07752-248300-05,414805Fax: 07752-409999EmergencyIAmbulance:1066/243310/414514