PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Fri, 15 Jun :45:14 GMT) CTRI Number CTRI/2010/091/ [Registered on: 12/07/2010] - Last Modified On 07/10/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial A Phase III Randomized Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on a Sulfonylurea in Combination With Metformin A Phase III Randomized Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on a Sulfonylurea in Combination With Metformin Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) version date 13Jan2010 DCGI NCT Designation Affiliation ClinicalTrials.gov Details of Principal Investigator Not Applicable N/A Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Dr Swashraya Shah medical director MSD pharma Phone Fax Designation Affiliation msd Pharma, 6th floor Vatika Towers- tower-b, Sec-54 Gurgaon HARYANA swashraya_shah@merck.com Details Contact Person (Public Query) Dr Swashraya Shah medical director MSD Pharma Phone msd Pharma, 6th floor Vatika Towers- tower-b, Sec-54 Gurgaon HARYANA page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax Source of Monetary or Material Support > Merck & Co., Inc. Global Headquarters One Merck Drive P.O. Box 100 Whitehouse Station, NJ USA Phone: Primary Sponsor Details Merck Co Inc One Merck Drive P.O. Box 100 Whitehouse Station, NJ USA Type of Sponsor NIL List of Countries Democratic People's Republic of Korea of Principal Investigator Dr. Arthur Joseph Asirvatham Dr Shreeram Mahadeevan Dr Paramesh Shamanna Dr Mala Dharmalingham Dr Vaishali Deshmukh Pharmaceutical industry-global of Site Site Phone/Fax/ Arthur Asirvatham Hospital Associates in Clinical Endocrinology Education and Research (ACEER), Clinisearch Endocrinology and Diabetes Research Center Deshmukh Clinic and Research Center 42-A, Kuruvikaran Salai, Madurai TAMIL NADU 7/12, 15th Cross Street, Sastri Nagar,,Adyar Chennai TAMIL NADU Medical College, No 416, 4th Cross, 2nd Block,,Kalyan Nagar, KARNATAKA #35, 5th Cross, Malleshwaram Circle,, KARNATAKA 4th Floor, Mulay Arcade Tilak Road, Pune MAHARASHTRA Dr Sanjeev Phathak DHL Research Centre 2nd Floor Thakershy Trust Hospital,Opposite Vimanagar, Satellite, Ahmadabad GUJARAT Dr M Jali Diabetes Department Nehru Nagar, Belgaum KARNATAKA Dr Anuradha Mudanna Diabetomics Private Limited /17B Hindi Nagar,,Behind Panjagutta Saibaba Temple, drajasirvatham@yahoo. co.in / /61 aceerchennai@gmail.c om drparamesh2@gmail.co m drmala@bedrc.com docvaishali@yahoo.co.i n phatak_sanjeev@yaho o.co.in drmvjali@gmail.com drmanuradha@gmail.co m page 2 / 6

3 Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Dr Pramod Gandhi Dr Balamurugan Ramanathan Gandhi?s Research Institute Kovai Diabetes Speciality Centre and Hospital, Hyderabad ANDHRA PRADESH C1 Shreevardhan Complex,Ramdaspeth, Wardha Road Nagpur MAHARASHTRA 15, Vivekanand Road, Ramnagar,Coimbatore Coimbatore TAMIL NADU drpdgandhi1@yahoo.co.in balamurugan_dr@hotm ail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Astha Independent EC Approved 01/05/2010 Yes Central Ethics Committee Endocrinology and Diabetes Research Center Ethics Committee on Human Research Central Medical Research Ethics Committee Approved 27/04/2010 Not Available Approved 04/06/2010 No Approved 27/05/2010 Yes CLINICOM Approved 31/05/2010 Yes CLINICOM Approved 20/05/2010 Yes EC OF KLE UNIVERSITY Institutional Ethics Committee of Kovai Diabetes Speciality Centre& Hospital Institutional Review Board Arthur Asirvatham Hospital National Ethics Committee Status Approved 29/05/2010 No Approved 13/05/2010 No Approved 31/05/2010 No Approved 10/06/2011 Yes Date Approved/Obtained 30/11/2011 Health Type Patients Condition Diabetes Type Details Intervention sitagliptin: Experimental Drug: sitagliptin phosphate Phase A: sitagliptin 100 mg once a day for 24 weeks; Phase B: sitagliptin 100 mg once a day for 30 weeks Drug: Comparator: placebo to pioglitazone Phase B: placebo to pioglitazone 30 mg once a day for 30 weeks Drug: Comparator: glimepiride or gliclazide Phase A: stable page 3 / 6

4 Inclusion Criteria Comparator Agent Age From Age To Gender Details placebo/pioglitazone: Active Comparator Year(s) Year(s) Both Inclusion Criteria gliclazide; Phase B: stable gliclazide Drug: Comparator: metformin Phase A: stable investigator, of metformin; Phase B: stable dose, as prescribed by investigator, of metformin Drug: Comparator: pioglitazone rescue therapy Phase A: patients not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These patients will not initiate Phase B double blind pioglitazone. Drug: Comparator: placebo to sitagliptin Phase A: placebo to sitagliptin 100 mg once a day for 24 weeks; Phase B: placebo to sitagliptin once a day for 30 weeks Drug: Comparator: pioglitazone Phase B: pioglitazone 30 mg once a day for 30 weeks Drug: Comparator: glimepiride or gliclazide Phase A: stable gliclazide; Phase B: stable gliclazide Drug: Comparator: metformin Phase A: stable investigator, of metformin; Phase B: stable dose, as prescribed by investigator, of metformin Drug: Comparator: pioglitazone rescue therapy Phase A: patients not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These patients will not initiate Phase B double blind pioglitazone. Patient has type 2 diabetes mellitus Patient has an A1C of % Patient is currently taking a stable dose of metformin and either glimepiride or gliclazide for at least 10 weeks prior to study start Patient has an acceptable blood sugar level at study screening Patient is a male, or a female who is highly unlikely to conceive page 4 / 6

5 Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Coin toss, Lottery, toss of dice, shuffling cards etc Centralized Exclusion Criteria Participant, Investigator and Outcome Assessor Blinded Patient has type 1 diabetes mellitus or ketoacidosis Patient is taking a DPP-4 inhibitor (such as sitagliptin) Patient is on a weight loss program not in the maintenance phase or on a weight loss medication Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer Patient is HIV positive Patient is pregnant Primary Outcome Outcome Timepoints Change from baseline of A1C as compared to Time Frame: Baseline and 24 weeks ] placebo [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ] Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Change from baseline in 2-hour post-meal Time Frame: Baseline to 24 weeks glucose (PMG)(following a standard meal), compared with the addition of placebo [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ] A change in fasting plasma glucose (FPG) (compared with the addition of placebo, in patients who are taking glimepiride or gliclazide and metformin) [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No Total Sample Size=424 Sample Size from =150 13/07/ /06/2010 Years=2 Months=0 Days=0 Completed Completed - date of enrollment was 23-June-10. total is upto 200 subjects. The trial is a Phase III Randomized Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on a Sulfonylurea in Combination With Metformin page 5 / 6

6 Powered by TCPDF ( PDF of Trial The primary outcome is Change from baseline of A1C as compared to placebo [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ] The secondary outcome is Change from baseline in 2-hour post-meal glucose (PMG)(following a standard meal), compared with the addition of placebo [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ] A change in fasting plasma glucose (FPG) (compared with the addition of placebo, in patients who are taking glimepiride or gliclazide and metformin) page 6 / 6