| CTRI Number |
CTRI/2009/091/001081 [Registered on: 21/01/2010] |
| Last Modified On: |
11/03/2013 |
| 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
Modification(s)
|
A clinical trial to study the effects of Linagliptin in patients with type 2 diabetes mellitus despite taking metformin therapy in combination with pioglitazone. |
Scientific Title of Study
Modification(s)
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A phase III, randomized, double blind, placebo-controlled parallel group efficacy and safety study of Linagliptin 5 mg administered orally once daily over 24 weeks in type 2 diabetic patients with insufficient glycaemic control despite a therapy of metformin in combination with pioglitazone |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BI 1218.61 |
Protocol Number |
| NCT00996658 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Shubhangi Desai |
| Designation |
Associate Director-CPM |
| Affiliation |
SIRO Clinpharm Pvt. Ltd. |
| Address |
Associate Director-CPM
SIRO Clinpharm Pvt. Ltd.
DIL Complex, II Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road
Thane
MAHARASHTRA
400 610
India |
| Phone |
02225848000 |
| Fax |
02225848275 |
| Email |
shubhangi.desai@siroclinpharm.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shubhangi Desai |
| Designation |
Head Clinical Operations - Asia Pacific |
| Affiliation |
SIRO Clinpharm Pvt. Ltd. |
| Address |
SIRO Clinpharm Pvt. Ltd.
DIL Complex, II Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road
Thane
MAHARASHTRA
400 610
India |
| Phone |
02225848000 |
| Fax |
02225848275 |
| Email |
shubhangi.desai@siroclinpharm.com |
|
Source of Monetary or Material Support
Modification(s)
|
|
Primary Sponsor
Modification(s)
|
| Name |
Boehringer Ingelheim Pharmaceuticals Inc |
| Address |
900 Ridgebury Road, Ridgefield, CT 06877,
U.S.A. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India
France
Philippines
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suman R |
Bangalore Diabetes Hospital |
16/M, Miller tank bed area, Thimmaiah road, Vasanthanagar,
Bangalore - 560 052, Karnataka, India.
Bangalore
KARNATAKA |
919845109070
sumangowda@hotmail.com |
| Dr Mala Dharmalingam |
Bangalore Endocrinology and Diabetes Research Center |
No. 35, 5th Cross, Malleshwaram Circle, Bangalore - 560 003, Karnataka, India.
Bangalore
KARNATAKA |
919845208163
bedrc.endo@gmail.com |
| Dr Rakesh Kumar Parikh |
D Clinarch |
C 56, Ramnagar, Shastrinagar,
Jaipur - 302 016
Jaipur
RAJASTHAN |
919351384427
pi@dclinarch.com |
| Dr Ajay Dande |
Dande Diabetes and Heart care center |
49, Bhagwant, Maya Nagar,
N-2, CIDCO,
Aurangabad - 431 005, Maharashtra, India
Aurangabad
MAHARASHTRA |
919890168956
drdande@yahoo.com |
| Dr Sharad Pendsey |
Diabetes Care & Research Centre |
Shreenivas, Opposite Dhantoli Park, Nagpur -440012.
Maharashtra, India.
Nagpur
MAHARASHTRA |
917122421898
sharad_ngp@sancharnet.in |
| Dr Sujit Chandratreya |
Endocare Clinic |
Mohiniraj Building, Gangapur road, Near Vidya Vikas Circle, Nasik - 422 013.
Nashik
MAHARASHTRA |
919422249250
sujitchandratreya@yahoo.com |
| Dr Shehla Shaikh |
K G N Diabetes and Endocrinology centre |
Patel Arcade, 1st Floor, Shop No. 9810, Nagpada, Mumbai - 400 008.
Mumbai
MAHARASHTRA |
919820984842
drshehla@rediffmail.com |
| Dr Paramesh Shamanna |
Medisys Clinisearch India Pvt Ltd |
Bangalore Diabetes Center, No 426, 4th Cross, 2nd Block, Kalyan Nagar, Bangalore - 560 043.
Bangalore
KARNATAKA |
919845010610
dr_paramesh@hotmail.com |
| Dr Rakesh Kumar Sahay |
Osmania General Hospital |
Dept of Endocrinology, 2nd Floor, Golden Jubilee Block, Osmania General Hospital, Afzalgani,
Hyderabad - 500 012.
Hyderabad
ANDHRA PRADESH |
919849597507
sahayrk@gmail.com |
| Dr Tushar Bandgar |
Research Health Institute in Diabetes Endocrinology and Metabolism (RHIDEM) |
1/15, Rupal Apartments,
98, 3rd Floor, Opp. Aroma Restaurant, Dadasaheb Phalke road, Dadar (E), Mumbai - 600 014.
Mumbai
MAHARASHTRA |
919820025037
drtusharb@gmail.com |
|
Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Bangalore Central Ethics Committee |
Approved |
| Bangalore Diabetes Hospital Ethics Committee |
Approved |
| Bangalore Endocrinology and Diabetes Research Centre Ethics Committee on Human Research |
Approved |
| Bio-Compatible Ethics Committee |
Approved |
| Clinical Ethics Forum |
Approved |
| Ethical Control Committee |
Approved |
| Independent Ethics Committee |
Approved |
| K G N Ethics Committee |
Approved |
| Medisys Clinisearch Ethical Review Board |
Approved |
| Osmania Medical College: Ethics Committee |
Approved |
| Swasthya Kalyan Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Linagliptin |
5mg/day , 24 weeks |
| Comparator Agent |
Metformin |
greater than or equal to 1500 mg/day or MTD, 24 weeks |
| Comparator Agent |
Pioglitazone |
45 mg/day or MTD,24 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Diagnosis of type 2 Diabetes Mellitus prior to Informed consent
2. Male and female patients pretreated with metformin and pioglitazone;antidiabetic therapy has to be unchanged for 12 weeks prior to Informed consent
3. Metformin therapy should be greater than or equal to1500 mg/day or on the maximum tolerated dose for 12 weeks prior to Informed consent
4. Pioglitazone therapy should be 45 mg/day or the maximum clinically acceptable dose in investigators opinion. The dose should be unchanged for 12 weeks prior to Informed consent
5. Glycosylated haemoglobin A1 (HbA1c) greater than or equal to 7.5% and less than or equal to10% at visit 1 (randomization criterion)
6. Age greater than or equal to 18 and less than or equal to 80 years at Visit 1 (Screening)
7. BMI less than or equal to 45 kg/m2 (Body Mass Index) at Visit 1(Screening).
8. Signed and dated written Informed consent by date of visit 1 in accordance with GCP and local legislation.
Note: patients currently treated with a total daily dose of metformin of less than 1500 mg can be included in the trial if investigator has documented that the dose is maximum tolerated dose of metformin for that patient.
|
|
| ExclusionCriteria |
| Details |
1. Uncontrolled hyperglycemia with a glucose level greater than 240 mg/dl (greater than13.3mmol/L) after an overnight fasting or greater than 400 mg/dl (greater than 22.2 mmol/L)in a randomly performed measurement during placebo run in and confirmed by secondary measurement (not on the same day).
2. Myocardial infarction, stroke or TIA within 3 months prior to informed consent.
3. Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1.
4. Gastric Bypass surgery.
5. Known hypersensitivity or allergy to the investigational product or its excipients, metformin or pioglitazone.
6. Metformin and/or pioglitazone are not used in accordance with prescribing information.
7. Treatment with rosiglitazone, GLP-1 analogues, DPP-4 inhibitor or insulin within 3 months prior to informed consent
8. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
9. Alcohol or drug abuse within the 3 months prior to informed consent that in the investigators opinion would interfere with trial participation
10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
11. Participation in another trial with an investigational drug within 2 months prior to informed consent
12. Pre-menopausal women (last menstruation less than or equal toƒn1 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 transdermal patch, intrauterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomized partner. |
|
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 |
| Change from baseline in HbA1c value |
24 weeks of treatment |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Occurrence of a treat to target response that is an HbA1c under treatment of less than 7.0 % |
24 weeks of treatment.
|
| Occurrence of a treat to target response that is an HbA1c under treatment of < 6.5 % |
24 weeks of treatment.
|
| Occurrence of a relative efficacy response (HbA1c lowering by at least 0.5 %) |
24 weeks of treatment.
|
| HbA1c reduction from baseline |
Visit over time |
| Change from baseline in fasting plasma glucose (FPG) |
24 weeks of treatment.
|
| Change from baseline in FPG |
Visit over time |
|
Target Sample Size
Modification(s)
|
Total Sample Size="290"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
04/02/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
03/11/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
Modification(s)
|
Short description of the primary purpose of the protocol, including a brief statement of the study hypothesis. This study is a randomized, double blind, parallel group, multi-centre trail comparing the safety and efficacy of Linagliptin 5 mg daily for 6 months in 290 patients with diabetes that will be conducted in seven centers in India and sixty three in USA, France and Philippines. The primary outcome measures will be the change from baseline in HbA1c values after 24 weeks of treatment. The secondary outcomes will be occurrence of a treat to target response that is an HbA1c under treatment of < 7.0 % after 24 weeks of treatment. Occurrence of a treat to target response that is an HbA1c under treatment of < 6.5 % after 24 weeks of treatment. Occurrence of a relative efficacy response (HbA1c lowering by at least 0.5 % after 24 weeks of treatment). HbA1c reduction from baseline by visit over time. Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment. Change from baseline in FPG by visit over time.
Expected date of First Enrollment in India - 4th February 2010
The final (actual) enrollment from India - 140 patients. |