GETWELL INSTITUTIONAL ETHICS COMMITTEE (GIEC)

Dr. Rajesh SwarnakarD.N.B. (Pulmonary Medicine)DTCD, FCCP (USA)Member SecretaryPh: (0712) 6632203

Prof. Dr.A.G.ShembekarM.D. (Pharmacology)

Chairman(M) 9822578307

REGD. OFFICE: 20/1, Getwell Hospital and Research Institute, Room no B-2, Dr Khare Marg,

Dhantoli, Nagpur-440012(lndia) TEL: 0712-6632200, 6632240

FAX: 0712-2441046, 2461249 email: giec201@gmail.com

MEMBERS:

Dr. Jitendra HazareMS,MCH (Paed Surgeon)(M) 9822203622

Dr. Jayesh TimaneMD, Physician(M) 9823584876

Dr. Vikrant SaojiMD (Dermatology)(M) 9822697892

-Mr.Hitesh MatteD.PharmPharmacist,(M) 9822561109

Adv. S.W. MaruskarLLS, Lawyer(M) 9370999234

Ms. Shilpa AgrawalMSc,Social Counselor(M)9890627404

Mr.Agnelo PintoSA, Lay Person(M) 9373284869

Ref.No. GIEC/12/1222-01 Date: 01/Jan/2013

To,

Dr. Jayashri Shembalkar .

20/1,Getwell Hospital and Research Institute

Dr.Khare Marg, Dhantoli, Nagpur-440012

Ref Study No: GPL/CT/2012/00S/1I1

Study Title: "A Randomized, Double Blind, Comparative,Prospective, Multicentre, Parallel Study to assessEfficacy,Safety and Tolerability of Fixed Dose Combinationof Repaglinide / Metformin IR Tablet Compared withMetforrnin IR Tablet Monotherapy or Repaglinide TabletMonotherapy in Adult Patients with Type 2 DiabetesMellitus Inadequately Controlled on Metformin Alone."

Subject: Ethics Committee approval of study related

documents for the referenced study.

• Dear Dr.Shembalkar

With ref. to your letter to us dated: 19/Nov/2012.The GetwellInstitutional Ethics Committee reviewed the study documents

for the clinical trial entitled "A Randomized, Double Blind,Comparative, Prospective, Multicentre, Parallel Study toassess Efficacy,Safety and Tolerability of Fixed Dose

. Combination of Repaglinide / Metformin IR TabletCompared with Metformin IR Tablet Monotherapy orRepaglinide Tablet Monotherapy in Adult Patients with

Page 1 of 4

--GETWELL INSTITUTIONAL ETHICS COMMITTEE (GIEC)

Dr. Rajesh'SwarnakarO.N.B. (Pulmonary Medicine)OTCO, FCCP (USA)Member SecretaryPh: (0712)6632203

Prof. Dr.A.G.ShembekarM.D. (Pharmacology)

Chairman(M) 9822578307

REGD. OFFICE: 20/1, Getwell Hospital and Research Institute, Room no B-2, Dr Khare Marg,

Dhantoli, Nagpur-440012(lndia) TEL: 0712-6632200, 6632240

FAX: 0712-2441046, 2461249 email: giec201@gmail.com

MEMBERS:

Dr. Jitendra HazareMS,MCH (Paed Surgeon)(M) 9822203622

Dr. Jayesh TimaneMO, Physician(M) 9823584876

Dr. Vikrant SaojiMO (Dermatology)(M) 9822697892

-Mr.Hitesh MatteD.PharmPharmacist,(M) 9822561109

Adv. S.W. MaruskarLLB, Lawyer(M) 9370999234

Ms. Shilpa AgrawalMSc,Social Counselor(M) 9890627404

Mr.Agnelo PintoBA, Lay Person(M) 9373284869

Type 2 Diabetes Mellitus Inadequately Controlled onMetformin Alone."On 22/Dec/2012 at 5.00 pm.

The following documents were reviewed:

•

I. Protocol Version 2.0 dated 12/0ct/20l2.2. Patient Information Sheet and Informed Consent Formin English, Version 3.0 dated 17/0ct/2012, Customized forDr. Jayashri Shembalkar on 05/Nov/2012.3. Patient Information Sheet and Informed Consent Formin Hindi, Version 2.0 dated 29/0ct/20l2, Customized forDr. Jayashri Shembalkar on 05/Nov/2012.4: Patient Information Sheet and Informed Consent Formin Marathi, Version 2.0 dated 23/0ct/2012, Customizedfor Dr. Jayashri Shembalkar on 05/Nov/20l2.5. Patient Diary in English, Version 2.0 dated 12/octI2012.6. Patient Diary in Hindi, Version 2.0 dated l2/oct/20l2,Translated from English to Hindi on 30/oct/2012.7. Patient Diary in Marathi, Version 2.0 dated 12/0ct/2012,Translated from English to Marathi on 02/NovI2012.8. Owner's Guide for One Touch Select Simple BloodGlucose Monitoring System, in English.9. Owner's Guide for One Touch Select Simple BloodGlucose Monitoring System, Translated from English toHindi on 02/Nov/20l210. Owner's Guide for One Touch Select Simple BloodGlucose Monitoring System, Translated from English toMarathi on 05/Nov/20l21]. Case Report Form Version 3.0 dated 05/Nov/2012with updated pages 7, 8, 9, 11, 15, 19 & 23.

12. Investigator's undertaking dated 01lOct/20l2.

Page 2 of4

--GETWELL INSTITUTIONAL ETHICS COMMITTEE (GIEC)

Dr. Rajesh SwarnakarD.N.B. (Pulmonary Medicine)DTCD, FCCP (USA)Member SecretaryPh: (0712) 6632203

Prof. Dr.A.G.ShembekarM.D. (Pharmacology)

Chairman(M) 9822578307

REGD. OFFICE: 20/1, Getwell Hospital and Research Institute, Room no B-2, Dr Khare Marg,

Dhantoli, Nagpur-440012(lndia) TEL: 0712-6632200, 6632240

FAX: 0712-2441046, 2461249 email: giec201@gmail.com

MEMBERS:

Dr. Jitendra HazareMS,MCH(Paed Surgeon)(M) 9822203622

Dr. Jayesh TimaneMD, Physician(M) 9823584876

Dr. Vikrant SaojiMD (Dermatology)(M) 9822697892

Mr.Hitesh MatteD.PharmPharmacist,(M) 9822561109

Adv. S.W. MaruskarLLS, Lawyer(M) 9370999234

Ms. Shilpa AgrawalMSc,Social Counselor(M) 9890627404

Mr.Agnelo PintoSA, Lay Person(M)9373284869

13. Clinical Trial Agreement dated 09/Aug/2012.14. DCGI Submission Letter dated 10/Aug/20l2 &15/0ct/20 12.

The following members of the Ethics Committee were

present at the meeting held on 22/Dec/2012 at 5.00 pm at

Getwell Hospital and Research Instituite, 20/1, Dr. Khare

rnarg, Dhantoli, Nagpur-440012.The quorum met as perICH-GCPand schedule Y.

•

Name M I Qualification Designa Sl Affiliation Contact NoF tion NS to the

InstituteDr.A.G M Pharmacologist Chairma S No 9822578307Shembekar n

Dr.Rajesh M D.N.B Member S Yes 0712-Swamakar (Pulmonary Secretary 2226219

Medicine),M.B.B.S,D.T.C.D

Adv.S.W. M LLB, Lawyer Member NS No 9370999234Maruskar

Ms.Shilpa F M.Sc(Human Member NS No 9890627404Agarwal Development),

Social Worker& Counselor

Mr. Agnelo M B.A, Lay Member NS No 9373284869Pinto personMr.Hitesh M D ..Pharm, Member S No 9822561109Matte Pharmacist

We approve the trial to be conducted in its presented form. Wehereby confirm that neither you nor any of your study team members

have participated in the voting/ decision making procedure of thecommittee. The members ofthe committee who have participated in

the voting decision making procedure of the committee do not have

any conflict of interest in the referenced study.

Page 30f4

- -GETWELL INSTITUTIONAL ETHICS COMMITTEE (GIEC)

Dr. Rajestl SwarnakarD.N.B. (Pulmonary Medicine)DTCD, FCCP (USA)Member SecretaryPh: (0712) 6632203

Prof. Dr.A.G.ShembekarM.D. (Pharmacology)

Chairman(M) 9822578307

REGD. OFFICE: 20/1, Getwell Hospital and Research Institute, Room no B-2, Dr Khare Marg,

Dhantoli, Nagpur-440012(lndia) TEL: 0712-6632200, 6632240

FAX: 0712-2441046, 2461249 email: giec201 @gmail.com

MEMBERS:

Dr. Jitendra HazareMS,MCH (Paed Surgeon)(M)9822203622

Dr. Jayesh TimaneMD, Physician(M) 9823584876

Dr. Vikrant SaojiMD (Dermatology)(M) 9822697892

Mr.Hitesh MatteD.PharmPharmacist,(M)9822561109

Adv. S.W. MaruskarLLS, Lawyer(M) 9370999234

Ms. Shilpa AgrawalMSc,Social Counselor(M) 9890627404

Mr.Agnelo PintoSA, Lay Person(M) 9373284869

The Getwell Institutional Ethics Committee expects to be informedabout

1. The progress of the study yearly.

2. Any SAEoccurring in the course of the study.

3. Any changes in the protocol and patient information/informedconsent.

Also you are requested to provide a copy ofthe final report.

Yours Sincerely,

Mc.nilJ~:rSecretaryGetweU timUQ;n~ltthic~ Cormuittet

Member secretary

Getweliinstitutional Ethics Committee

•

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