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Independent Ethics Co-mmittee (IEC)Regd. No. 1433/1999 G.B.B.S.D.

ChairmanDr. R. D. Lele FRCP(Tel. No.: 022-2202 1817)

Member SecretaryDr. Raakhi Tripathi MD(Tel. No.: 022 - 2301 2223)

Associate Member SecretaryDr. R. B. Pandit MD FICP(Tel. No.: 022-2765 7025)

Adddress for Correspondence:Dept. of Clinical Pharmacology

BYL Nair Hospital and TN MedicalCollege,Old RMO Building, 5th Floor,Bombay Centi:al, Mumbai-400 008.Telefax: 022-230~23E-Mail: iecmumbai99@gmail.com

Date: 25th jan20 12Annex 3

AF/03/0 1-S0P06/0 1

INDEPENDENT ETHICS COMMITTEE

PROJECT APPROVAL LETTER

i-Address of Ethics Committee - TNMC & BYL Nair Charitable Hospital II Campus G bldgAth floor, '

L' Dr. A.L. Nair Road, I____ Mumbai Central, Mumbai 400 008. __ ~

I Principal Investigator: - D~.Ma~oj S. Chawla Ii Lina DIabetes Care CentreI 003/2 Yashodhan Aprtmnts, Four Bungalows Junction iI J. P Road, Andheri (W), Murnbai- 400053 iI 'I II l

1'1 Clinical trial protocol title: "NN9068-3912-A trail comparing the efficacy and safety II of Insulin Degludec/Liraglutide and Insulin Degludec in subjects with Type 2\i Diabetes" _(I EC111115) ii !

i The Independent Ethics Committee has reviewed the following documents submitted!

I for the above - mentioned clinical study .I

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- bmission application form signed &dated 20" Oct 2011 1-+---12. Trial Protocol: I I .

! >I . '"Trial 10: NN9068-3912, Title of Protocol: A trial comparing the II !efficacy ,,~d.•.~;,;.£.:-lY of Insulin Degludec/l.iraghuide and Insulin Dcgludeci Iin subjects with Type 2 Diabetes. Tria! Phase: 3a, Version: l.0, Status: i I

I' Final and Dated: 28 JUT) 2011_ I I I__~__. ._. .______ _ L ~

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Members: Rev. Jonah David, Dr. Mrs. Sandhya Kamat MD, Dr. Sandeep Bavdekar MD. Dr. R. K. Sharma MD, r». U. M_Thatte MO, PhD,Dr. D. N. Upasani MS, LLB, Ms. Nruta Vasudev M.A., M.S.W, Dr. Mrs. Kanchan Patil BSc_. B.Libs .. MA, Dr. Renuka Munshi MD

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NN9068-3912, Diabetes Diary No. ! to 10, English-India, Version: !.OJStatus: Final, Dated: i6 Au£ 2011. i

NN9068-3912, Diabetes Di:ry General, English-India, Version: j.O iN,!

3. Appendix- A, B, C, D, E & F, Version 1.0: Status: Final and Dated: 28Jun 2011.

4. Attachment J - Global, Version: 1.0, Status: Final and Dated: 28 Jun2011.

5. Attachrnent-Il -Country-India, Version: 1.0, Status: Final and Dated:12 Aug2011.

6. Subject Information and Informed Consent FOI'm- English:Main Subject Information/Informed consent (English):

NN9068-3912, Subject Information/Informed Consent, English-India,Version: 1.1 IN, Status: Final, Dated: 09 Dec 2011.

Addendum to SIIIC-Genetic testing (English):

NN9068-3912, Addendum to SI/lC-Genetic Testing, English-India,Version: 1.1_iN, Status: Final, Dated: 09 Dec 201 1.

7. Subject Information and Informed Consent Form- Hindi andMarathi with Verification of Transiation(VOT):Main Subject Informationiinformed consent (Hindi) with VOT:

NN9068-3912, Subject Information/Informed Consent, Hindi-India,Version: 1.l_IN, Status: Final, Dated: 12 Dee 20J 1.

~ Addendum to SIIIC-Genetic testing (Hindi) with VOT:

NN9068-3912, Addendum to SIIlC, Hindi-India, Version: 1.1 IN,Status: Final, Dated: !2 Dee 20 II.

Main Subject Information/Informed consent (Marathi) with VOT:

NN9068-3912, Subject Information/Informed Consent, Marathi-India,

Version: 1.1_1N, Status: Final, Dated: 12 Dee 2011,

Addendum to SI/IC-Genetic testing with (Marathi) with VOT:

NN9068-3912, Addendum to Sl/1C, Hindi-India, Version:1.1_JN,

Status: Final, Dated: 12 Dee 20 II

8. Translation& Back translation certificate for SubjectInformation/InformedConsent & Addendum to STIIC-Genetic testing in Hindi and Marathilanguage

9. Diabetes Diary - English:Diary No 1 to 10 & General Instruction:

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10. Diabetes Diary - Hindi: IDiary No 1 to 10 & General Instruction (Hindi): I

NN9068-3912, Diabetes Diary No.1 to 10, Hindi-India, Version: 1.0_IJStatus: Final, Dated: 23 Sep 2011. 'INN9068-3912, Diabetes Diary General, Hindi-India, Version: 1.0_11",1, IStatus: Final. Dated:23 Sep 2011. I.. I

11. Diabetes Diary- Marathi: Diary No 1 to 10 & General Instruction I(Marathi): !

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INN9068-3912, Diabetes Diary No.1 to 10, Marathi -India, Version: 1.0!Status: Final, Dated: 23 Sep 2011. 1

INN9068~3912, Diabetes Diary General, Marathi -India, Version: 1.0_1~Status: Final, Dated: 23 Sep 2011. I

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12. Patient ID card: INN9068-3912, ID card, English-India, Version: 1.0_IN, Status:Final, Dated: 16 Aug 2011.NN9068-3912, lD card, Hindi- India, Version: 1.0_IN, Status: Final,Dated: 29 Aug 2011.NN9068-3912, lD card, Marathi -Tndia, Version: 1.0_IN, Status:Final, Dated: 29 Aug 2011.

Status: Final, Dated: 16 Aug 2011

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'"13. Handling Instructions:

Directions for use for FlexPen@ Applies to: Insulin degludec/Liraglutideor Insulin degludec, Trial ID: NN9068-39i2; Version: 1742-FlexPen-Solution for Injection-v05-IN(EN).Directions for use for FlexPen®. Applies to: Insulin degludec/Liraglutideor Insulin degludec, Trial 10: NN9068-3912; Version: 1742-FlexPen-Solution for injection-v05-INCHI).Directions for use for FlexPen®. Applies to: Insulin degludec/Liraglutideor Insulin degludec, Trial 10: NN9068-3912; Version: 1742-FlexPen-Solution for Injection-v05-IN(MR).

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14. Blood Glucose Meter Instruction Manual:Optium Xceed User Manual: User's Guide; Dated: 23 Aug 2006.

e15. eCRF:

NN9068-3912, eCRF Mock-Up, Version: 0.1, Dated: 01- July-20ll.NN9068-3912, Safety or MESi Forms, Version: O. l , Dated: 01- J uly-2011.NN9068-3912, Adverse Event Follow-up Form, Safety InformationForm, Pregnancy Forms & Technical Complaint Form, Version: 0.2,Dated: 01 July 20 II.

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16. Insurance:* Global Insurance: XL Insurance Certificate of Insurance, Dated: 14 April

2011.e Local Insurance: HDrC ERGO General Insurance Company Limited,

Clinicai Trial certification, Dated: 29 July 20 II.@ Physician Indemnity Statement.

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]7. Trial Investigator documents: .@ Curriculum Vitae of PI & MRC~ Undertaking by the PI

18. Investigator's Brochure

lB of Insulin Degludec (N"N 1250-lDeg), Edition 6, Version: 1.0, Dated: 16-Nov-2010, Status: FinallB of Insulin Degludec/Liraglutide (NN9068-lDeglLira), Edition 3,Version:1.0, Dated: 12-Jan -2011, Status: Final

19. DCGlapprovalletter20Jan2012

20. Investigator Agreement Edition 5.0/ August 2011 Ver 2.0_IN

21. Site Profile

22. Clinical Trial Members with their roles and responsibilities

23. Confirmatory note from the Principal Investigator stating that the

above mentioned trial will be conducted in accordance with Schedule

Y and Ethical Guidelines for Biomedical Research on Human

participants; ICMR 2006.

24. lCH-GCP Training certificate of Dr. Manoj Chawla and Ms. Sonam

Kachalia (Study coordinator)

25. Memorandum of Understanding between BSES MG Hospital and Dr.

Manoj Chawla

26. Ethics Committee approval letters from other sites

Approval letter dated 23 Nov 2011 from ETHICS COMMITTEE of ILSHOSPITAL to Dr. Ghanshayam GoyalApproval letter dated 29 Oct 2011 from Getwell Hospital and Research!nstitue to Dr. Shailesh PitaleApproval1etter dated 24 Oct 201] from Ethics Committee of Bini waleClinic to Dr. Yogesh KadarnA pproval letter dated 22 Nov 201 i from 'Madras Diabetes ResearchFoundation to Dr. V. Mohan

27. Reply letter dale 21 s: Ian 2012 in response to lEe query letter date

! S!i:Dee 201 I

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28. Reply letter date 12thDee 2012 and 13th Dee 20 l I in response to lEe c> vquery letter date 17th Noy 20 I 1

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MEMBERS PRESENT AT MEETING (25/0112012) TO APPROVE PROJECTVenue of the meeting: Dept. ofClinicaJ Pharmacology, KEM Hospital

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r Members I Highest Degrees Sex Designation Area of expertise Status 1I

IIi Earned (P/ABS) I

FRCP 'M Chairperson, I Physician P II

Clinician Ii

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., MD IF Member Secretary, Pharmacologist PiDLRaaI Medical Scientist

-~I IMD I~IAssociate Member I CardiologistI Dr.R. B. PanditI I I Secretary, Treasurer,I

I Clinician II

Or.U. M. Thatte I MO PhD IF Member, Medical Clinical P I

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II Scientist I Pharmacologist

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Dr.R. K. Sharma jMD M Member; Clinician I Gynecologist & I ASS

II I Hospital

I administratorI Dr.D. N. Upasani MS LLB M Member, Legal Surgeon, P

I I expert Anesthesiologist, i

I I Clinician & Medico !

I iI legal consultant !

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I Ms.Nruta VasudevII MA,M.S.W I F I Social worker I Community II

I I I ...........I.1.J"-''-'l I II Rev.Jonah David MA 1M Lay Member i Pastor

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II I I i iI Dr.Sandeep Bavdekar MO,DCH 1M Member, Clinician I Pediatrician Ip I~Dr.Sandhya Kamat ~---jMD F Member, Medical Pharmacologist

IScientist I I

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I I MO ONB Member, Medical ClinicalI '!I

lI Ms.Kanchan Patil

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I Scientist

IPharmacologist

I B S B lib ~"'----r- r! • C.; . I .,-,C., !"I Ii M.A., M.L.l.S., II L.L.B !

Member, Legalexpert

Chief MedicalLibrarian

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ABS denotes Absentees P denotes Present

We hereby confirm that neither you nor any of your study team members have participated indecision making procedure of ethics committee. The members of the committee who haveparticipated in the decision making procedure of the committee do not have any conflict ofinterest in the referenced study.

"The Independent Ethics Committee hereby confirm that the composition and operatingprocedures of Independent Ethics Committee Mumbai, are as per Amended Schedule Y(20th January 2005) and ICH-GCP guidelines"

The approval for the study has been granted and the study can be initiated at the specified trialsite on 25th January 2012

The research proponents are hereby informed that the Independent Ethics Committee (lEC) willrequire the following:

J .AII adverse events those are either serious or unexpected to be reported within 7 workingdays to the IEC. If SAE is death it must be reported within 24 hours.

2. The progress report to be submitted to the IEC at least annually. In the absence of receipt ofthe same by 26thFebruary2013 the IEC may revoke the permission to conduct the study.

3.Upon completion/premature termination of the study, a final study status report includingsummary of results needs to be submitted to the If.C,

4.Ail protocol deviations /changes in the protocol must be informed to the lEe in writing andnotification / approval from the lEe must be taken. No change in the protocol (amendment)must be implemented without approval of the IEe

5.The Pi must promptly report the following to the lEC:a) Any 'new information' acquired during the course of the trial that may adversely

affect the safety of the subjectb) Any 'change' in the protocol that will increase the existing risk /subject the research

participants to new risks during the course of the trial6.The PI must ensure all required regulatory/administrative approvals are taken before

execution of the trial.7.You are also requested to follow Ethical aspects of the ciinical trial as described in the

booklet 'Ethical Guidelines for Biomedical Research on Human Participants, ICMR 2006'

In the above circumstances measures taken by the PI to protect the research participants andeliminate hazards must be specified

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A maximum of 30 patients will be screened at this tria! site

A maximum of20 patients will be enrolled at this trial site

DECISION

Opinion of the Independent Ethics Committee for Research on Human Subjects(lEe)

___ ~"-I __ Approval

____ Provisional approval

Disapproval

Date of approval: 25/0112012I

Chairperson J

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