| CTRI Number |
CTRI/2010/091/001299 [Registered on: 08/10/2010] |
| 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 Study With BI 10773 vs. Placebo as add-on to Metformin or Metformin Plus Sulfonyurea Over 24 Weeks in Patients With Type 2 Diabetes
|
Scientific Title of Study
Modification(s)
|
A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orallly, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Suflonylurea |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 1245.23 |
Protocol Number |
| 2009-016258-41 |
EudraCT |
| NCT01159600 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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 |
|
Details of Contact Person
Scientific 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 |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Viraj Suvarna |
| Designation |
Medical Director |
| 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 |
viraj.suvarna@boehringer-ingelheim.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Boehringer Ingelheim Pharma GmbH Co KG |
| Address |
Department of Clinical Operations + BDM (Cardiology/Metabolism)Birkendorfer Straße 6588397 Biberach/ RißGermanyPhone: +49 7351 54-8243 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Eli Lilly and Company |
|
|
Countries of Recruitment
Modification(s)
|
India
Canada
China
France
Germany
Mexico
Republic of Korea
Slovakia
Slovenia
Taiwan
Turkey
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaishali Deshmukh |
Deenanath Mangeshkar Hospital & Research Centre |
Department of Diabetology,Near Mhatre Bridge, Erandawne-411030
Pune
MAHARASHTRA |
+91-20-66023001
+ 91-20-25420104
docvaishali@yahoo.co.in |
| Dr Sunil Kumar Jain |
Diabetes Thyroid Hormone Research Institute Private Limited |
BCM Health Island, PU4, Scheme 54,Behind Prestige Management Institute, Near Bombay Hospital-452010
Indore
MADHYA PRADESH |
00917312443200
00917312443250
sunilmjain@gmail.com |
| Dr Pramod Gandhi |
Gandhi Research Institute |
Department of Endocrinology and Diabetology,C-1 Shreewardhan Complex, Wardha Road, Ramdaspeth-440010
Nagpur
MAHARASHTRA |
+91-712-2460302
+91-712-2440120
drpdgandhi@yahoo.co.in |
| Dr Shreerang Godbole |
INSTRIDE |
6, Poonam Arcade, Revenue Colony,1170/ 11, Shivaji Nagar-411005
Pune
MAHARASHTRA |
+91-20-25521833
+91-20-25530899
instridepune@gmail.com |
| Dr. Girithara Gopalakrishnan Jayaram Naidu |
K G Hospital & Post Graduate Medical Institute |
Department of Diabetology ,No. 5 Govt Arts College Road-641018
Coimbatore
TAMIL NADU |
+91-422-2212121
+91-422-2218721
drgirimd@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Central India Medical Research Ethics Committee |
Approved |
| Ethics Committee of Diabetes Thyroid Hormone Research Institute Pvt Ltd |
Approved |
| Ethics Committee, INSTRIDE |
Approved |
| Institutional Ethics Committee |
Approved |
| Regional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
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 tablets |
10 mg once daily |
| Intervention |
BI 10773 Tablets |
25 mg Once Daily |
| Intervention |
BI 10773 tablets |
25 mg once daily open label |
| Comparator Agent |
Placebo matching BI 10773 tablets |
10 mg once daily |
| Comparator Agent |
Placebo matching BI 10773 tablets |
25 mg once daily |
|
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 a diet and exercise regimen who are pre treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation.
Minimum dose for metformin: greater than or equal to 1500 mg per day or maximum tolerated dose or maximum dose according to local label Minimum dose for sulfonylurea: greater than or equal to half of the maximal recommended dose or maximum tolerated dose or maximum dose according to local label
3. HbA1c of greater than or equal to 7.0 per cent and less than or equal to 11 per cent at Visit 1 (screening) in order to be eligible for randomised treatment HbA1c of greater than 11 per cent at Visit 1 (screening) in order to be eligible for the open-label treatment arm (25 mg BI 10773)
4. Age in between 18 and 65
5. Body Mass Index BMI less than or equal to 45 kg per meter square (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 greater than 240 mg per dl (greater than 13.3 mmol per L) after an overnight fast during placebo run in and confirmed by a second measurement (not on the same day)
2. Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2
3. Myocardial infarction, stroke or transient ischemic 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 times upper limit of normal (ULN) as determined during screening and/or run-in phase
5. Impaired renal function, defined as eGFR less than 30 ml per min (severe renal impairment) as determined during screening and/or run-in phase
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. Contraindications to metformin and/or sulfonylurea according to the local label for those patients that enter the study with the respective background therapy
9. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)
10. 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
11. 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 Typ 2 Diabetes
12. 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 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
13. 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
14. Participation in another trial with an investigational drug within 30 days prior to informed consent
15. Any other clinical condition that would jeopardize patients 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 after 24 weeks. |
24 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The body weight (kg) change from baseline after 24 weeks. |
24 weeks |
| The mean daily plasma glucose (MDG) change from baseline after 24 weeks of treatment. |
24 weeks |
| Occurrence of a treat to target response, (i.e. an HbA1c under treatment of < 7.0%) |
24 weeks |
| Occurrence of relative efficacy response (HbA1c lowering by at least 0.5%) |
24 weeks |
| The change in HbA1c and FPG by visit over time |
24 weeks |
| The change in fasting plasma glucose (FPG), waist and systolic and diastolic blood pressure from baseline to week 24 |
24 weeks |
| The composite endpoint of the following conditions at week 24: HbA1c lowering by a least 0.5%, lowering of systolic blood pressure by at least 3 mm Hg and decrease in body weight by more than 2%. |
24 weeks |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1390"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
17/11/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
29/07/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not published as yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic control. Open-label arm: to estimate efficacy and safety of 25 mg BI 10773 in very poorly controlled patients (HbA1c > 11%). Approximately 150 trial sites from 12 countries will participate in this study. Approximately 128 patients will be recruited from India from 5 sites. The first patient from India is expected to be screened on 20 October 2010.
The trial is completed. The findings will be provided in due course of time once available. |