| CTRI Number |
CTRI/2010/091/001474 [Registered on: 15/10/2010] |
| Last Modified On: |
15/09/2014 |
| 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
Modification(s)
|
Efficacy and Safety of BI 10773 in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin |
Scientific Title of Study
Modification(s)
|
A randomised, double-blind, placebo-controlled parallel group efficacy and safety trial of BI 10773 (10 and 25 mg administered orally once daily) over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycaemic control despite a background therapy of pioglitazone alone or in combination with metformin |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 1245.19 |
Protocol Number |
| NCT01210001 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Veeraswamy Seshiah |
| Designation |
Coordinating Investigator |
| Affiliation |
V Seshiah Diabetes Research Institute |
| Address |
Balaji Diabetes Care Centre,
729 PH Road Aminjikarai,
Chennai
Chennai
TAMIL NADU
600029
India |
| Phone |
|
| Fax |
|
| Email |
vseshiah@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Tapankumar M Shah |
| Designation |
Trial Clinical Monitor |
| Affiliation |
Boehringer Ingelheim India Private Limited |
| Address |
Boehringer Ingelheim India Pvt. Ltd.
1102, 11th Floor, Hallmark Business Plaza,
Guru Nanak Hospital Road,
Near Guru Nanak Hospital,
Bandra (East), Mumbai 400 051
Mumbai
MAHARASHTRA
400051
India |
| Phone |
00919930358846 |
| Fax |
|
| Email |
tapankumar.shah@boehringer-ingelheim.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Partha Gokhale |
| Designation |
Head - Clinical Operations |
| Affiliation |
Boehringer Ingelheim India Private Limited |
| Address |
Boehringer Ingelheim India Pvt. Ltd.
1102, 11th Floor, Hallmark Business Plaza,
Guru Nanak Hospital Road,
Near Guru Nanak Hospital,
Bandra (East), Mumbai 400 051
Mumbai
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
partha.gokhale@boehringer-ingelheim.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Boehringer Ingelheim Pharmaceuticals |
|
Primary Sponsor
Modification(s)
|
| Name |
Boehringer Ingelheim Ltd |
| Address |
Ellesfield AvenueSouthern Industrial EstateBracknell, BerkshireRG 12 8YSUNITED KINGDOMPhone: +44 1344 74-2535Fax: +44 1344 74-1657 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Eli Lilly and Company |
Lilly Corporate Center
Indianapolis, Indiana 46285 USA |
|
Countries of Recruitment
Modification(s)
|
Thailand
India
Canada
Greece
Philippines
Ukraine
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anish Behl |
Apollo BGS Hospital |
Adichunchanagiri Road,Kuvempunagar-570 023
Mysore
KARNATAKA |
+91-9342103964
+91-8212460870
anishbehl@rediffmail.com |
| Dr Shriraam Mahadevan |
Associates in CEER |
15th Cross Street,Shastrinagar Adyar-600020
Chennai
TAMIL NADU |
+91-9840488777
+91-44-24460760
aceergroup@gmail.com |
| Dr Sanjay Reddy |
Bangalore Diabetes Hospital |
16/M Miller Tank Bed Area,Thimmaiah Road, Vasanthnagar-560052
Bangalore
KARNATAKA |
+91-9886241898
+91-80-22372981
drsanjayreddy@yahoo.com |
| Dr Neeta Deshpande |
Belgaum Diabetes Centre |
Near Mahila Bhandar,Maruti Galli-590001
Belgaum
KARNATAKA |
+91-9880271313
+91-8314215380
neetadeshpande@hotmail.com |
| Dr B R Shivakumar |
Cosmopolitan Medical Centre |
5th Main, Kullapa Circle Road,Kammanahalli, St Thomas T Post-560084
Bangalore
KARNATAKA |
+91-9900329850
+91-80-25454565
dr_shiva_kumar@yahoo.co.in |
| Dr Ajay Kumar |
Diabetes Care & Research Centre |
GC 1B Near Over Bridge,Kankerbagh-800020
Patna
BIHAR |
+91-6122350434
+91-6122357332
drajaykr@yahoo.com |
| Dr Veeraswamy Seshiah |
Dr V Seshiah Diabetes Care and Research Institute |
No 729, P. H. Road ,Aminijikarai-600029
Chennai
TAMIL NADU |
+91-44-26641414
vseshiah@gmail.com
+91-44-26640660 |
| Dr Mohan Magdum |
Jehangir Hospital |
Department of Internal Medicine,32, Sassoon Road,-411001
Pune
MAHARASHTRA |
+91-20-66811756
+91-20-26059319
mohanmagdum@gmail.com |
| Dr Ravikumar Y S |
JSS Medical College Hospital |
Department of General Medicine,Ramanuja Road-570004
Mysore
KARNATAKA |
+91-9448055503
+91-8212548368
ysravikumar@gmail.com |
| Dr Shehla Shaikh |
KGN Diabetes&Endocrine Centre |
Patel Shopping Arcade,1st Floor, Nagpada Junction-400008
Mumbai
MAHARASHTRA |
+91-9820984842
+91-22-23021514
drshehla@rediffmail.com |
| Balamurugan Ramanathan |
Kovai Diabetes Centre |
15 Vivekanand Road,Ramnagar-641009
Coimbatore
TAMIL NADU |
+91-9842244881
+91-4224377714
balamurugan_dr@hotmail.com |
| Dr Sreenivasa Murthy |
Life Care Clinic and Research Centre |
# 2253, M.C.N. Complex, Kodigehelli Main Road,Sahakara Nagar-560092
Bangalore
KARNATAKA |
+91-9448051046
+91-80-23630055
drsreenivasa murthy@gmail.com |
| Dr Dinesh Dhanwal |
Maulana Azad Medical College |
Department of Internal Medicine, Associated Loknayak Hospital,Room no.115, B.L.Taneja Block-110002
New Delhi
DELHI |
+91-9968604275
+91-11-23235793
dineshdhanwal@hotmail.com |
| Dr Tushar Bandgar |
Research Health Institute in Diabetes, Endocrinology & Metabolism (RHIDEM) |
1/15, Rupal Apartment, 3rd floor,Opposite Aroma Hotel, Dadasaheb Phalke Road, Dadar East-400014
Mumbai
MAHARASHTRA |
919820025037
drtusharb@gmail.com |
| Dr B A Rudrawadi |
Rudrawadi Hospital |
Diabetes care and research Centre,# 1-949, Plot no. 71/3A/15A Balaji Nagar, Old Jewargi road-585102
Gulbarga
KARNATAKA |
+91-9448194677
+91 8472270277
dr.rudrawadi@gmail.com |
| Dr Shailaja Kale |
Sahyadri Hospital |
Centre of excellence for Diabetes, Bibewadi,Plot no. 13, S No. 573, Swami Vivekanand Marg-411037
Pune
MAHARASHTRA |
+91-9822055458
+91-20-67213722
drshailajakale@yahoo.com |
| Dr Sunil Gupta |
Sunil Diabetes Care And Research Centre Pvt Ltd |
42, Lendra Park,,Ramdaspeth-440010
Nagpur
MAHARASHTRA |
+91-7122428111
+91-7122428555
mail@dcrcindia.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| Bangalore Central Ethics Committee/Dr Shivakumar |
Approved |
| Bangalore Diabetes Hospital Ethical Committee/Dr Reddy |
Approved |
| CLINICOM Ethics Committee for Evaluation of Protocols for Clinical Research/Bangalore/Dr B A Rudrawadi) |
Approved |
| CLINICOM Ethics Committee for Evaluation of Protocols for Clinical Research/Bangalore/Dr Neeta Deshpande) |
Approved |
| CLINICOM Ethics Committee for Evaluation of Protocols for Clinical Research/Bangalore/Dr Tushar Bandgar) |
Approved |
| Ethical Committee of Diabetes Care and Research Centre/Nagpur/Dr Gupta |
Approved |
| Ethics Committee - Dr. V. Seshiah Diabetes Research Institute/Chennai/Dr Seshiah |
Approved |
| Ethics Committee Apollo BGS Hospital/Mysore/Dr Behl |
Approved |
| Institutional Ethical Committee of JSS Medical College/Mysore/Dr Ravikumar |
Approved |
| Institutional Ethics Committee of Kovai Diabetes Speciality Centre and Hospital/Coimbatore/Dr Balamurugan |
Approved |
| Institutional Ethics Committee, Hirabai cowasji Jehangir Medical Research Institute & Jehangir Clinical Development Centre/Pune/Dr Magdum |
Approved |
| Institutional Ethics Committee, Maulana Azad Medical College/Delhi/Dr Dhanwal |
Approved |
| Institutional Review Board Diabetes Care and Research Centre/Patna/Dr Ajay Kumar |
Approved |
| KGN Ethics Committee/Mumbai/Dr Shaikh |
Approved |
| Life Care Ethics Committee/Bangalore/Dr Murthy |
Approved |
| National Ethics Committee/Chennai/Dr Mahadevan |
Approved |
| Sahyadri Ethics Committee/Pune/Dr Kale |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
BI 10773 tablet |
10 mg once daily for 24 weeks |
| Comparator Agent |
placebo matching BI 10773 10 mg tablet |
Once daily for 24 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of type 2 diabetes mellitus prior to informed consent.
2. Male and female patients on diet and exercise regimen who are pre-treated with pioglitazone alone or in combination with metformin. The treatment regimen should be unchanged for 12 weeks prior to randomisation.
3. HbA1c of greater than or equal to 7.0% and less that or equal to 10.0% at Visit 1 (screening).
4. Age greater than or equal to 18 and less than or equal to 65.
5. BMI less than or equal to kg per 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. Any other antidiabetic medication within 12 weeks prior to randomisation, except those defined as the permitted background therapy via inclusion criteria no. 2
3. Myocardial infarction, stroke or transient ischaemic attack (TIA) within 3 months prior to informed consent
4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during
screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3)
5. Impaired renal function, defined as eGFR (estimated Glomerular Filtration Rate) 30 ml/min (severe renal impairment, MDRD [Modification of Diet in Renal Disease]
formula) as determined during screening or during the placebo run-in period (i.e. at a visit prior to the randomisation visit, Visit 3)
6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
8. Blood dyscrasias or any disorders causing haemolysis or unstable red blood cells (e.g. malaria, babesiosis, haemolytic anaemia)
9. Contraindications to pioglitazone according to the
local label
10. Contraindication to pioglitazone and/or metformin (relevant only for those patients who enter the study with both these background therapies) according to the local labels
11. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 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
12. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2D
13. 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 practicing an acceptable method of birth control, or do not plan to continue using this method throughout the trial 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 to local authorities), double barrier method and vasectomised partner
14. Alcohol or drug abuse within the 3 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
15. Participation in another trial with an investigational drug within 30 days prior to informed consent
16. Any other clinical condition that would jeopardise patient safety while participating in this clinical trial |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The change from baseline in HbA1c |
Baseline and 24 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The change from baseline in fasting plasma glucose (FPG) |
Baseline and 24 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="468"
Sample Size from India="205"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
29/10/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
12/10/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Publication is not available as yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a randomised, double-blind, placebo-controlled parallel group comparison Randomisation will be stratified by background therapy, HbA1c at Visit 1 and by renal function at Visit 1 (normal renal function eGFR ≥ 90 ml/min, mild impairment eGFR 60-89 ml/min and moderate renal impairment eGFR 30-59 ml/min). The objective of the current trial is to investigate the efficacy, safety and tolerability of BI 10773 (10 and 25 mg once daily) compared to placebo given for 24 weeks as add-on therapy to pioglitazone alone or in combination with metformin in patients with type 2 diabetes mellitus (T2DM) with insufficient glycaemic control. Approximately 220 patients will be recruited from India for 18 sites. The first patient from India in this study will be enrolled on 29 October 2010.
Trial is completed. Results will be updated in due course of time. |