Efficacy of BI 10773 Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2010/091/002809
• Date of registration: 21-10-2010
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim Pharma GmbH Co KG
• Public title: Efficacy of BI 10773 Versus Placebo and Sitagliptin Over 24 Weeks in Patients With Type 2 Diabetes
• Scientific title: A phase III randomised, double-blind, placebo-controlled parallel group efficacy and safety study of BI 10773 and sitagliptin administered orally over 24 weeks, in drug naïve patients with type 2 diabetes mellitus and insufficient glycaemic control despite diet and exercise
• Date of first enrolment: 29-10-2010
• Target sample size: 920
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2232
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, China, Germany, India, Japan, Singapore, Swaziland, United Kingdom, United States of America

Contacts

• Name: Mr Tapankumar M Shah
• Affiliation: Boehringer Ingelheim India Private Limited

• Name: Dr Partha Gokhale
• Affiliation: Boehringer Ingelheim India Private Limited

Key inclusion & exclusion criteria

Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent



2. Male and female patients on diet and exercise regimen who are drug-naïve, defined as absence of any oral or injectable anti-diabetes therapy for 12 weeks prior to randomisation or start of active open-label treatment (25 mg BI 10773)



3. HbA1c - ≥ 7.0% and < 10.0% at Visit 1 (screening) in order to be eligible for randomised treatment - > 10.0% at visit 1 (screening) in order to be eligible for the open-label BI 10773 arm



4. Age ≥ 20 (Japan) Age ≥ 18 (countries other than Japan)



5. BMI (Body Mass Index) ≤ 45 kg/m2 at Visit 1 (screening)



6. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation
Exclusion criteria: 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. Myocardial infarction, stroke or TIA within 3 months prior to informed consent



3. 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 and/or run-in phase



4. Impaired renal function, defined as eGFR50 ml/min (moderate to severe renal impairment; MDRD formula) as determined during screening and/or run-in phase



5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption



6. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years



7. Contraindications to sitagliptin according to the local label



8. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anaemia)



9. Treatment with any anti-diabetes drug within 12 weeks prior to randomisation or start of active open-label treatment (25 mg BI 10773)



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 T2DM.



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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Type 2 Diabetes Mellites

Intervention(s)

Intervention1: BI 10773 tablets: 10 mg once daily for 24 weeks
Intervention2: BI 10773 tablets: 25 mg once daily for 24 weeks
Intervention3: BI 10773 tablets: 25 mg once daily open label for 24 weeks
Control Intervention1: Sitagliptin tablet: 100 mg once daily for 24 weeks
Control Intervention2: placebo matching BI 10773 tablet: 10 and 25 mg once daily for 24 weeks
Control Intervention3: placebo matching Sitagliptin tablet: 100 mg once daily for 24 weeks

Primary Outcome(s)

Change from baseline in HbA1c after 24 weeks of treatment (%)Timepoint: 24 weeks

Secondary Outcome(s)

Body weight: Change from baseline to week 24Timepoint: 24 weeks

Systolic and diastolic blood pressure (SBP and DBP): Change from baseline to week 24Timepoint: 24 weeks

Secondary ID(s)

1245.20

NCT01177813

Source(s) of Monetary Support

Boehringer Ingelheim Pharmaceuticals

Secondary Sponsor(s)

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 01/07/2010
Contact:

Institutional Ethics Committee of Kovai Diabetes Speciality Centre and Hospital/Coimbatore/Dr Balamurugan

Status: Approved
Approval date: 02/07/2010
Contact:

Bangalore Diabetes Hospital Ethical Committee/Bangalore/Dr Reddy

Status: Approved
Approval date: 05/07/2010
Contact:

CLINICOM Ethics Committee for Evaluation of Protocols for Clinical Research/Bangalore/Dr Bandgar

Status: Approved
Approval date: 12/07/2010
Contact:

CLINICOM Ethics Committee for Evaluation of Protocols for Clinical Research/Bangalore/Dr Deshpande

Status: Approved
Approval date: 16/07/2010
Contact:

Bangalore Central Ethics Committee/Bangalore/Dr Shivakumar

Status: Approved
Approval date: 22/07/2010
Contact:

Ethical Committee of Diabetes Care n Research Centre

Status: Approved
Approval date: 26/07/2010
Contact:

Ethics Committee - Dr. V. Seshiah Diabetes Research Institute

Status: Approved
Approval date: 31/07/2010
Contact:

National Ethics Committee/Chennai/Dr Mahadevan

Status: Approved
Approval date: 19/09/2010
Contact:

Life Care Ethics Committee

Status: Approved
Approval date: 27/09/2010
Contact:

KGN Ethics Committee/Mumbai/Dr Shaikh