Efficacy and Safety of BI 10773 in Type 2 Diabetes Patients on a Background of Pioglitazone Alone or With Metformin

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: CTRI/2010/091/001474
• Lead Sponsor: Boehringer Ingelheim Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-29
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 468

Inclusion Criteria

• Diagnosis of type 2 diabetes mellitus prior to informed consent.
• 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.
• HbA1c of greater than or equal to 7.0% and less that or equal to 10.0% at Visit 1 (screening).
• Age greater than or equal to 18 and less than or equal to 65.
• BMI less than or equal to kg per m2 (Body Mass Index) at Visit 1 (screening).
• Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (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. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change from baseline in HbA1c	Baseline and 24 weeks

Secondary Outcome Measures

Name	Time	Method
The change from baseline in fasting plasma glucose (FPG)	Baseline and 24 weeks

Trial Locations

Locations (17)

Apollo BGS Hospital; 🇮🇳 Mysore, KARNATAKA, India

Associates in CEER; 🇮🇳 Chennai, TAMIL NADU, India

Bangalore Diabetes Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Belgaum Diabetes Centre; 🇮🇳 Belgaum, KARNATAKA, India

Cosmopolitan Medical Centre; 🇮🇳 Bangalore, KARNATAKA, India

Diabetes Care & Research Centre; 🇮🇳 Patna, BIHAR, India

Dr V Seshiah Diabetes Care and Research Institute; 🇮🇳 Chennai, TAMIL NADU, India

Jehangir Hospital; 🇮🇳 Pune, MAHARASHTRA, India

JSS Medical College Hospital; 🇮🇳 Mysore, KARNATAKA, India

KGN Diabetes&Endocrine Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

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Apollo BGS Hospital

🇮🇳Mysore, KARNATAKA, India

Dr Anish Behl

Principal investigator

91-9342103964

anishbehl@rediffmail.com