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Date of approval: 16.Nov, 2011 Date of issue: 21.Nov, 2011

Institutional Ethics CommitteeApollo Hospitals,Lingiadih Village, Seepat road,Bilaspur,(Chhattisgarh).Ph.: 07752-243300-05.Fax: 07752-409999.

Name and Address of EthicsCommittee:

Ethics Committee Decision

Study Code: H9X-MC-GBDJ(a) (REWIND)The effect of Dulaglutide on Major Cardiovascular Events in patients withType 2 Diabetes: Researching Cardiovascular Events with a Weekly INcertin

Study Protocol Title: in Diabetes (REWIND)

Sponsor Eli Illy

CRO (if any) ICON Clinical Research India Pvt. Ltd.

Principallnvestigator(s) Dr. Kalpana Dash

Name and address of Trial Apollo Hospitals, Bilaspur.

Site(s): (Chhattisgarh)

The Ethics Committee has reviewed the following documents related to theabove study:

Document (including version number, version date if applicable)

1. H9X-MC-GBDJ (a) (REWIND) clinical protocol (amendment (a» - Dated 03.Jun, 2011. Controlled Copynumber: 295 to 310

2. LY2189265 Investigator's Brochure - Dated- 03.Dec, 2010. Controlled copy number: 295 to 310.

3. Record of risk profile reviews and updates, Dated 30.Nov, 2010.

4. Patient information and consent forms.• English ICF: H9X-MC-GBDJ (REWIND) study specific MAIN SIS/ICF, India Version 2.0, Site

145 Version 1.0,07 SEP 2011• H9X-MC-GBDJ (REWIND) study specific MAIN SISIICF: India Version 2.0, Site 145, Version

1.0, 07.SEP, 2011 (HINDI).• H9X-MC-GBDJ (REWIND) study specific MAIN SIS/ICF: India Version 2.0, Site 145, Version

1.0, 07.SEP, 2011 (HlNDI)BT.,'-

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.• ~ ETHICS COMMITTEE.~ Apollo Hospital

Seepat Road, Bilaspur (C.G.)Ph.: 07752-243~OO, Fax: ~7752-~ 999r.

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5. Patient Documents:• Patient IDI Emergency Card in English, Hindi.

1. GBDJ_REWIND_IDlEmergency card_v1_9 July II_Master English2. GBDJ_REWIND_IDlEmergency card_vI_04 Oct II_Hindi

• Patient self injection guide in English.1. GBDJ_REWIND_Injection Guide_VI_08 June II_Master US English

• Scales in English and Hindi-1. DSST

1. Lionbridge 627405---DSST Instructions WAIS-IV---EnglishUK---OI April2011

2. Lionbridge 627405---DSST Instructions WAIS-IV--- Hindi---Ol April 20112. IlEF

1. lIEF English UK2. Inemational Index of Erectile Function Final Hindi Version

3. MoCA test1. TrasPerfect, TPT283231, MoCA Test, English-UK, Level 2 - Partial Linguistic

Validation, 4/20/112. Version 7.1 in Hindi

4. MoCA instructions1. TrasPerfect, TPT283231, MoCA instructions, English-UK, Level 2 - Partial

Linguistic Validation, 4/20/112. MoCA Version November 12,2001 in Hindi

5.6. Letter of intent for insurance from the sponsor.

7. eCRF layout for the study: study version 1, 30.Jun, 2011 and time and index schedule for the study:REWIND, study Version 1 dated 29.Jun, 2011.

8. Draft CTAg (Tripartite) H9X-MC-GBDJ-India Master-Tripartite-Version 1-17 AUG2011<Site#-Version1.0DateXXX> .

9. Copy ofDCGI acknowledgement submission letter dated 04.Aug, 2011.

10. Investigator's undertaking.

11. Investigator's MRC and CV.

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,A7 ETHICS COMMITTEE~ Apollo Hospital

Seepat Road, Bilaspur (C.G.)Ph.: 07752-243~OO, Fax: ~7752.4 9999

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Review and Approval

The study / study documents ~Are approved in their present formD Are not approved*o Required modification prior to approval*

*An explanation /comments are providedin comments section:

B"" Yes

o No

Comments (e.g. additional requirements for the Investigator, any reports required by ERBduring course of trial):

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~ ETHICS COMMITTEE,.A1 Apollo Hospital~ Seepat Road, Bilaspur (C.G.)

Ph.: 07752-243300, Fax:0775~-W999JDate~J/~~~L Sign.~ •.

Ethics Committee Members present during the decision making process:

The meeting was chaired by Dr. (Brig.) A. K. Sharma (COO Apollo Hospitals,Bilaspur).

S. no. Name Designation

1 Dr P Khapre (Chairman) Medical Director, Railway

2 Mr. Prashant Jayaswal Chhattisgarh high court

3 Mr. Sanjay Agrawal Bilaspur, Chhattisgarh

4 Dr.S.K Mohanty CIMS, Bilaspur Prof & HOD Surgery

5 Dr. (Brig.) A. K. Sharma COO Apollo Hospitals, Bilaspur

6 Dr Sunil Sharma Sr. Consultant, Neurosurgery,Apollo Hospitals, Bilaspur

8 Dr P P Misra Sr. Consultant, ENT, ApolloHospitals, Bilaspur

9 Dr Sushree Parida Sr. Consultant, Oncology, ApolloHospitals, BilaspurSr. Consultant, Obstetrics and

10 Dr Rashmi Sharma Gynaecology, Apollo Hospitals,Bilaspur

11 Dr. P. K. Panda (Member , Sr. Consultant, Microbiology,Secretary ) Apollo Hospitals, Bilaspur

13 Mrs.lndu Secretary- coo

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~ ETHICS COMMITTEEiAi Apollo Hospital~ Seepat Road, Bilaspur (C.G.)IPh.: 07752-243300, F~ : 07?5~-~9999

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None of the study team members participated in the decision making process.

This Ethics Committee is working according to ICH-GCP and applicable laws and regulations.The ERB expects to be informed about the progress of the study, any SAE occurring in thecourse of the study, any changes in the protocol and the patient information sheet! informedconsent and asks to be provided a copy of the final report.

2-1/11 /'l911Date of Issue Signature of Ch rman/Member Secretary of

Ethics Committee

Member SecretaryEthics Committee

Apollo Hospital, Bilaspur (C.G.)

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