Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatments bi 10773, glimepiride, placebo
Phase phase 3
Sponsor Boehringer Ingelheim
Collaborator Eli Lilly and Company
Start date August 2010
End date August 2013
Trial size 1549 participants
Trial identifier NCT01167881, 1245.28, 2009-016244-39

Summary

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment
Arm
(Experimental)
Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily
bi 10773
Medium dose once daily
placebo
Placebo matching Glimepiride
(Active Comparator)
Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.
glimepiride
1-4 mg once daily
placebo
Placebo matching BI 10773

Primary Outcomes

Measure
The change from baseline in HbA1c after 52 weeks of treatment.
time frame: baseline and 52 weeks
The change from baseline in HbA1c after 104 weeks of treatment.
time frame: Baseline and 104 weeks

Secondary Outcomes

Measure
The change in body weight from baseline after 52 weeks of treatment.
time frame: baseline and 52 weeks
The occurrence of confirmed hypoglycaemic events during 52 weeks of treatment.
time frame: baseline and 52 weeks
The change in blood pressure (SBP and DBP ) from baseline after 52 weeks of treatment.
time frame: baseline and 52 weeks
The change in body weight from baseline after 104 weeks of treatment.
time frame: baseline and 104weeks
The occurrence of confirmed hypoglycaemic events during 104 weeks of treatment.
time frame: baseline and 104 weeks
The change in blood pressure (SBP and DBP ) from baseline after 104 weeks of treatment.
time frame: baseline and 104 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: 1) Diagnosis typ 2 diabetes mellitus, 2) male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation, 3)HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1, 4) 18 years or more, 5) BMI equal or less than 45Kg/m2. Exclusion criteria: 1) uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in, 2) any other antidiabetic drug within 12 weeks prior to randomisation except metformin,3) acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent,4) indication liver disease, 5) moderate to severe renal impairment, 6) bariatric surgery within past 2 years, 7) medical history of cancer or treatment for cancer within last 5 years, 8) blood dyscrasias or any disorders causing haemolysis or unstable red blood cell, 9) contraindications hypersensitivity to concomitant drugs,10) treatment with anti-obesity drugs

Additional Information

Official title A Phase III Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 10773 Compared to Glimepiride Administered Orally During 104 Weeks With a 104 Week Extension Period in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control Despite Metformin Treatment
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.