| CTRI Number |
CTRI/2010/091/000430 [Registered on: 26/10/2010] |
| Last Modified On: |
22/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone. The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied. |
|
Scientific Title of Study
|
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Asian Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MB102-055 |
Protocol Number |
| NCT01095666 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Deepak Bachani |
| Designation |
|
| Affiliation |
|
| Address |
Bristol Myers Squibb
6th floor Towers 1
Indiabulls Finance Centre
Senapati Bapat Marg Elphinstone (W)
Mumbai - 400013
Mumbai
MAHARASHTRA
400013
India |
| Phone |
912266534264 |
| Fax |
02266103739 |
| Email |
deepak.bachani@bms.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Subashri Shivkumar |
| Designation |
|
| Affiliation |
|
| Address |
BRISTOL-MYERS SQUIBB INDIA
6th floor Towers 1
Indiabulls Finance Centre
Senapati Bapat Marg Elphinstone (W)
Mumbai - 400013
Mumbai
MAHARASHTRA
400018
India |
| Phone |
02266534245 |
| Fax |
02266614378 |
| Email |
subashri.shivkumar@bms.com |
|
|
Source of Monetary or Material Support
|
| The pharmaceutical company sponsoring this study is Bristol-Myers Squibb |
|
Primary Sponsor
Modification(s)
|
| Name |
The pharmaceutical company sponsoring this study is BristolMyers SquibbAddress |
| Address |
6th floor Towers 1
Indiabulls Finance Centre
Senapati Bapat Marg Elphinstone (W)
Mumbai - 400013
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Rakesh Parikh |
D Clinarch, |
Unnati Towers, Central Spine, Vidayadhar Nagar,-302013
Jaipur
RAJASTHAN |
drrakeshparikh@gmail.com |
| Dr. Nihal Thomas |
Department of Endocrinology/Metabolism |
Christian Medical College,-632004
Vellore
TAMIL NADU |
+91-416-228-2528
+91-416-23630055
nihal_thomas@yahoo.com |
| Dr. Sreenivasa Murthy |
Life care Clinic & research centre, |
#2253 MCN Complex,,Kodigehalli main rd.,Sahkar nagar-560092
|
+91-9448051046
080-23630055
drsreenivamurthy@gmail.com |
| Dr. Sanjay Reddy |
Medisys Clinisearch India Private Limited, |
Bangalore Diabetes Centre,,No. 426, 4th Cross, 2nd Block, Kalyan Nagar,-560043
|
+91-80-25457022
+91-80 25425396
drsanjayreddy@yahoo.com |
| Dr. Sunil M. Jain |
TOTALL Diabetes Hormone Institute |
BCM Health Island, PU4, Scheme 54,,Behind Prestige Management Institute,-452010
Indore
MADHYA PRADESH |
+91-9826023182
sunilmjain@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics committee at CMC Vellore |
Approved |
| Ethics Committee of Diabetes Thyroid Hormone Research Institute, Indore |
Approved |
| Ethics Committee of Life Care Clinic & Research Centre |
Approved |
| Ethics Committee of Medisys Clinisearch India Private Limited |
Approved |
| Swasthya Kalyan Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dapagliflozin |
Tablets, Oral, 10 mg, Once daily, 24 weeks |
| Intervention |
Dapagliflozin |
Tablets, Oral, 5 mg, Once daily, 24 weeks |
| Comparator Agent |
Dapagliflozin Placebo |
Tablets, Oral, 0 mg, Once daily, 24 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- Males and females, 18 to 65 years old, with type 2 diabetes and with inadequate glycemic control
- Drug naive or treated with anti-diabetic medication for < 24 weeks
- C-peptide ≥ 1.0 ng/mL
- Body Mass Index ≤ 45.0 kg/m² |
|
| ExclusionCriteria |
| Details |
- AST and/or ALT > 1.5 times ULN
- Serum total bilirubin > 2 mg/dL
- Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
- Creatine kinase ≥ 3 times ULN
- Symptoms of severely uncontrolled diabetes
-Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in HbA1c for each dose of dapagliflozin vs placebo |
At week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in Fasting Plasma Glucose (FPG) |
At week 24 |
| Change from baseline in 2hr-post meal glucose |
At week 24 |
| Proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c < 7.0% |
At week 24 |
| Change from baseline in total body weight |
At week 24 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="444"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
28/02/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
17/06/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
First subject of the study was screened at Chinese site on 17th June 2010. First subject from India is expected by 15th November 2010. There are approximately 50 subjects to be randomized from India. |