| CTRI Number |
CTRI/2011/091/000060 [Registered on: 17/01/2011] |
| Last Modified On: |
03/06/2011 |
| 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
|
Efficacy and Safety of BI 10773 in Patients With Type 2 Diabetes and Renal Impairment
|
|
Scientific Title of Study
|
A phase III, randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of BI 10773 (10 mg and 25 mg administered once daily) as add on to pre-existing antidiabetic therapy over 52 weeks in patients with type 2 diabetes mellitus and renal impairment and insufficient glycaemic control |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 1245.36 |
Other |
| 2009-016179-31 |
EudraCT |
| NCT01164501 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Sandeep Nair |
| Designation |
Project Manager - Clinical Operations |
| Affiliation |
Boehringer Ingelheim India Pvt. Ltd. |
| 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 |
02226456163 |
| Email |
sandeep.nair@boehringer-ingelheim.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Sandeep Nair |
| Designation |
Project Manager - Boehringer Ingelheim |
| Affiliation |
Boehringer Ingelheim India Pvt. Ltd. |
| 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 |
02226456163 |
| Email |
sandeep.nair@boehringer-ingelheim.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Partha Gokhale |
| Designation |
Head Clinical Operations |
| Affiliation |
Boehringer Ingelheim India Pvt. Ltd. |
| 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 |
02226456163 |
| Email |
partha.gokhale@boehringer-ingelheim.com |
|
|
Source of Monetary or Material Support
|
| Boehringer Ingelheim Pharmaceuticals |
|
Primary Sponsor
Modification(s)
|
| Name |
Boehringer Ingelheim Pharmaceuticals |
| 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 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Canada
France
Israel
Malaysia
Netherlands
Other
Philippines
Poland
Portugal
Russian Federation
Slovakia
South Africa
Spain
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| 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 |
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 Sujit Chandratreya |
Endocare Clinic |
Mohiniraj, Gangapur Road, Nasik, 422 013, Maharashtra, India
Nashik
MAHARASHTRA |
02533290783
02532317466
sujitchandratreya@yahoo.com |
| 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 Shehla Shaikh |
KGN Diabetes & Endocrinology Centre |
9/10, Patel Arcades, 1st floor, Nagpada Junction , Mumbai-400008, Maharashtra, India
Mumbai
MAHARASHTRA |
02223021515
02223021514
drshehla@rediffmail.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-600086
Chennai
TAMIL NADU |
04443968888
04428350935
tmcramu2000@yahoo.co.in |
| Dr. Ambrish Mithal |
Medanta - The Medicity |
Sector-38,,-122 001
Gurgaon
HARYANA |
0124 4834000, Ext - 6236
0124 4834468
ambrish.mithal@medanta.org |
| 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= 16 |
| Name of Committee |
Approval Status |
| Astha Independent Ethics Committee Approval |
Approved |
| Bangalore Central Ethics Committee |
Approved |
| Bio Ethical Committee, Aligarh Muslim University |
Approved |
| Clinical Ethics Forum |
Approved |
| Ethical Committee, Diabetic Clinic and Research Centre |
Approved |
| Ethics Committee, Bangalore Endocrinology and Diabetes Research Centre |
Approved |
| Ethics Committee, Diabetes Research Centre |
Approved |
| Ethics Committee, KEM Hospital and Research Centre |
Approved |
| Institutional Ethics Committtee - BGS Global Hospitals |
Approved |
| Madras Diabetes Research Foundation |
Approved |
| Mallikatta Ethical Committee |
Approved |
| Medanta Independent Ethics Committee |
Approved |
| Science for Health (Independent Ethics Committee) |
Approved |
| Society for Promotion of Ethical Clinical Trials |
Approved |
| Suraksha Institutional Ethics Committee |
Approved |
| Veridian Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetes Mellitus, Type 2
Renal Insufficiency
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BI 10773 |
10 mg, Once Daily |
| Intervention |
BI 10773 |
25 mg, Once Daily |
| Comparator Agent |
Placebo |
10 mg or 25 mg, Once Daily |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Diagnosis of type 2 diabetes mellitus prior to informed consent and a eGFR of <90 ml/min, as determined during screening and the run-in phase, using the Modification of Diet in Renal Disease (MDRD) equation.
2. Male and female patients on diet and exercise regimen who are pre-treated with any antidiabetic therapy (excluding only SGLT-2 inhibitors) and are on the maximum tolerated dose which has been unchanged for 12 weeks prior to randomisation.
? Metformin therapy should be ≥ 1500 mg/day or on the maximum tolerated dose or maximum dose according to local labelling
? The prescribed insulin dose should not be changed within the 12 weeks prior to randomisation by +/- 10% from the baseline value at randomisation
? Pioglitazone therapy should be ≥30 mg/day or maximum dose according to local labelling
? Sulphonylurea therapy should be ≥half the recommended maximal dose according to local labelling.
3. HbA1c of ≥7.0% and <10.0% at Visit 1 (screening).
4. Age ≥18 years (Restricted to patients <= 65 years of age as per upper age limit imposed by the DCG(I) for patients recruited in India).
5. BMI ≤45 kg/m2 (Body Mass Index) at Visit 1 (screening).
6. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation. |
|
| ExclusionCriteria |
| Details |
1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
2. Impaired renal function, defined as eGFR<15 ml/min using the MDRD equation as determined during screening and/or the run-in phase.
3. Renal impairment requiring any form of chronic dialysis.
4. Requiring acute dialysis within three months prior to informed consent.
5. Renal transplant recipient.
6. Myocardial infarction, stroke or Transient Ischemic Attack (TIA) within three months prior to informed consent.
7. Indication of liver disease, defined by serum levels of either Alanine transaminase (ALT) (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as
determined during screening and/or the run-in phase.
8. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption.
9. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last five years.
10. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cell (e.g. malaria, babesiosis, haemolytic anemia).
11. Contraindications to pre-existing background antidiabetic therapy according to the local label.
12. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) three months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight.
13. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within six weeks prior to informed consent or any other uncontrolled
endocrine disorder except T2DM.
14. Pre-menopausal women (last menstruation ≤1 year prior to informed consent) who:
- are nursing or pregnant or
- are of child-bearing potential and are not practising an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if acceptable by local authorities), double barrier method and vasectomised partner.
15. Alcohol or drug abuse within the three months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake.
16. Participation in another trial with an investigational drug within 30 days prior to informed consent.
17. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in HbA1c after 24weeks of treatment |
Baseline and 24 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in HbA1c after 52 weeks of treatment |
Baseline and 52 Weeks |
| Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 24 and 52 weeks of treatment |
Baseline, 24 Weeks and 52 Weeks |
| Occurrence of relative efficacy response (HbA1c lowering by a least 0.5% after 24 and 52 weeks of treatment |
Baseline, 24 Weeks and 52 Weeks |
| Change from baseline in HbA1c by visit over time |
Ongoing |
| Change from baseline in FPG after 24 and 52 weeks of treatmen |
Baseline, 24 Weeks and 52 Weeks |
| Change from baseline in FPG by visit over time |
Ongoing |
| Body weight and waist circumference: Change from baseline to week 24 and 52 |
Baseline, 24 Weeks and 52 Weeks |
| Systolic and diastolic BP: Change from baseline to week 24 and 52. |
Baseline, 24 Weeks and 52 Weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="682"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
04/03/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
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) |
Open to Recruitment |
Publication Details
Modification(s)
|
NIL |
|
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 BI 10773 (10 mg and 25 mg / once daily) compared to placebo given for 52 weeks as add-on therapy to pre-existing antidiabetic therapy in patients with type 2 diabetes with insufficient glycaemic control and renal impairment.
Approximately 125 trial sites from 16 countries will participate in this study. Approximately 150 patients will be recruited in India from 13 sites. The first patient from India is expected to be screened on 28 Jan 2011
|