| CTRI Number |
CTRI/2010/091/001212 [Registered on: 20/10/2010] |
| Last Modified On: |
16/11/2015 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy and Safety of BI 10773 With Metformin in Patients With Type 2 Diabetes |
|
Scientific Title of Study
|
A phase III randomised, double-blind, active-controlled parallel group efficacy and safety study of BI 10773 compared to glimepiride administered orally during 104 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin treatment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1245.28 |
Other |
| 2009-016244-39 |
EudraCT |
| NCT01167881 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Nair |
| Designation |
|
| Affiliation |
|
| Address |
Boehringer Ingelheim India Pvt. Ltd., 1102, 11th Floor, Hallmark Business Plaza
Guru Nanak Hospital Road, Near Guru Nanak Hospital, Bandra (East)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226456477 |
| Fax |
26456163 |
| Email |
sandeep.nair@boehringer-ingelheim.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep Nair |
| Designation |
|
| Affiliation |
|
| Address |
Boehringer Ingelheim India Pvt. Ltd., 1102, 11th Floor, Hallmark Business Plaza
Guru Nanak Hospital Road, Near Guru Nanak Hospital, Bandra (East)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226456477 |
| Fax |
26456163 |
| Email |
sandeep.nair@boehringer-ingelheim.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Partha Gokhale |
| Designation |
|
| Affiliation |
|
| Address |
Boehringer Ingelheim India Pvt. Ltd., 1102, 11th Floor, Hallmark Business Plaza
Guru Nanak Hospital Road, Near Guru Nanak Hospital, Bandra (East)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226456477 |
| Fax |
26456163 |
| Email |
partha.gokhale@boehringer-ingelheim.com |
|
|
Source of Monetary or Material Support
|
| Boehringer Ingelheim Pharmaceuticals |
|
|
Primary Sponsor
|
| Name |
Boehringer Ingelheim Pharmaceuticals |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Indonesia
Thailand |
Sites of Study
Modification(s)
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Satish Babu |
B G S Global Hospitals |
,#67, Uttarahalli Road,Kengeri-560060
Bangalore
KARNATAKA |
080 26255192
080 28605642
babu09_uk@yahoo.co.uk |
| Dr. Paramesh Shamanna |
Bangalore Clinisearch |
416, 4th cross, 2nd Block,Kalyan Nagar-560043
Bangalore
KARNATAKA |
080 25459001
080 25459006
drparamesh2@gmail.com |
| Dr. Mala Dharmalingam |
Bangalore Endocrinology and Diabetes Research Center (BEDRC) |
No. 35, 5th Cross, Malleshwaram,-560003
Bangalore
KARNATAKA |
080 40977108 Extn-26
080 41281998
drmala@bedrc.com |
| Dr. Jamal Ahmad |
Centre For Diabetes and Endocrinology |
Faculty of Medicine, Jawaharlal Nehru Medical College and Hospital,Aligarh Muslim University-202002
Aligarh
UTTAR PRADESH |
0571 2721544
0571 2721544
Jamalahmad11@rediffmail.com |
| Dr. Sanjeev Ratnakar Phatak |
D H L Research Center |
2nd Floor, Thakershy Trust Hospital,Opposite Vimanagar, Satellite-380015
Ahmadabad
GUJARAT |
079 26741177
079 26748899
phatak_sanjeev@yahoo.co.in |
| Dr. Chittaranjan Sakerlal Yajnik |
Diabetes Unit, KEM Hospital |
06th floor, Banoo Cayoji building,KEM Hospital and Research Centre, Sardar Moodliar Road, Rasta Peth-411011
Pune
MAHARASHTRA |
020 66405731
020 26111958
diabetes@vsnl.com |
| Dr. Monojit Ketan Mukhopadhyay |
Diabetic Clinic & Research Centre |
46/A, Ritchie Road,-700019
Kolkata
WEST BENGAL |
033 24756220
033 24756220
mkmukhopadhyay@yahoo.co.in |
| Dr. Satyanarayana Srikanta |
Jnana Sanjeevini Medical Centre |
2, 1A Cross Marenhalli,J P Nagar, Phase 2-560078
Bangalore
KARNATAKA |
080 26493040
080 26493050
jsmcindia@gmail.com |
| Dr. Uma Mahesh Kandikattu |
M V Hospital For Diabetes |
West Mada Church Street,Royapuram-600013
Chennai
TAMIL NADU |
044 25954913
044 25983444
mahesh.kandikattu@gmail.com |
| Dr Muthu Ramu |
Madras Diabetes Research Foundation |
No 4
Conran Smith Road
Gopalapuram
Chennai
6800086
Chennai
TAMIL NADU |
04443968888
04428350935
tmcramu2000@yahoo.co.in |
| Dr. Rajeev Chawla |
North Delhi Diabetes Centre |
180 Jai Apartments,Sector 9, Rohini-110085
New Delhi
DELHI |
011 27562031
011 47045282
rajeevaastikchawla@yahoo.com |
| Dr. Lilly Rodrigues |
Surakshaka Diabetic Centre |
MIG-218, K.P.H.B.,Main Road, Kukatpally-500072
Hyderabad
ANDHRA PRADESH |
040 23151000
040 40061930
drrlily@gmail.com |
| Dr. Hansraj Alva |
Vinaya Hospital And Research centre |
Karangalpady,-575003
Bangalore
KARNATAKA |
0824 4273761
0824 4273761
drhansrajalva@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| Astha Independent Ethics Committee |
Submittted/Under Review |
| Bangalore Central Ethics Committee |
Approved |
| Bio Ethical Committee, Aligarh Muslim University |
Submittted/Under Review |
| Ethical Committee, Diabetic Clinic and Research Centre |
Submittted/Under Review |
| Ethics Committee, Bangalore Endocrinology and Diabetes Research Centre |
Approved |
| Ethics Committee, Diabetes Research Centre |
Submittted/Under Review |
| Ethics Committee, KEM Hospital and Research Centre |
Approved |
| Institutional Ethics Committee, Madras Diabetes Research Foundation |
Approved |
| Institutional Ethics Committtee - BGS Global Hospitals |
Approved |
| Mallikatta Ethical Committee |
Submittted/Under Review |
| Science for Health (Independent Ethics Committee) |
Submittted/Under Review |
| Society for Prevention of Ethical Clinical Trials |
Submittted/Under Review |
| Suraksha Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetes Mellitus, Type 2 , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BI 10773 |
25 mg, once daily |
| Comparator Agent |
Glimeperide |
1-4 mg |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Inclusion Criteria:
1)Diagnosis type 2 diabetes mellitus,
2) male and female on diet and exercise regimen, drug naive or pre-treated with metformin 12 weeks prior to randomisation,
3)HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1,
4) 18 years or more (Restricted to patients <= 65 years of age as per upper age limit imposed by the DCG(I) for patients recruited in India),
5) BMI equal or less than 45Kg/m2. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1)uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in,
2)any other antidiabetic drug within 12 weeks prior to randomisation except metformin,
3) myocardial infarction, stroke or transient ischemic attack within 12 weeks of informed consent,
4) indication liver disease,
5)moderate to severe renal impairment,
6)bariatric surgery within past 2 years,
7)medical history of cancer or treatment for cancer within last 5 years,
8)blood dyscrasias or any disorders causing haemolysis or unstable red blood cell,
9)contraindications hypersensitivity to concomitant drugs,
10) treatment with anti-obesity drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in HbA1c after 104 weeks of treatment |
Baseline and 104 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Occurrence of Hypoglycaemic events |
52 weeks |
| Occurrence of Hypoglycaemic events |
104 Weeks |
| Occurrence of adverse events of protocol specific significant AEs |
52 weeks |
| Occurrence of Cardiovascular events (Clinical Event Committee adjudication results) |
52 Weeks |
| Occurrence of Cardiovascular events (Clinical Event Committee adjudication results) |
104 weeks |
| Occurrence of adverse events of protocol specific significant AEs |
104 Weeks |
| Incidence of Adverse events |
Baseline and 52 Weeks |
| Incidence of Adverse events |
Baseline and 104 Weeks |
| The change in blood pressure (SBP and DBP) |
Baseline and 104 weeks |
| The change in blood pressure (SBP and DBP) |
Baseline and 52 Weeks |
| The change in body weight |
Baseline and 104 Weeks |
| The change in body weight |
Baseline and 52 Weeks |
| The occurrence of confirmed symptomatic hypoglycaemic events |
Baseline and 104 Weeks |
| The occurrence of confirmed symptomatic hypoglycaemic events |
Baseline and 52 Weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1400"
Sample Size from India="163"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/08/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of the current study is to investigate the efficacy, safety and tolerability of BI10773 (25mg once daily) compared to glimepriride (1-4mg daily) given for 104 weeks in patients with type 2 diabetes mellitus and insufficient glycaemic control despite metformin. The study is designed to show non-inferiority of BI 10773 to glimepiride.
Approximately 200 trial sites from 23 countries will participate in this study. Approximately 220 patients will be recruited in India from 12 sites. The first patient from India is expected to be screened on 25 October 2010 |