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
- NCT01167881
- PHASE3
- INTERVENTIONAL
Last updated: 2016-09-02
Purpose of Trial
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.
This study is for people with
Diabetes Mellitus, Type 2
Interventions being studied
BI 10773
Glimepiride
Placebo
Placebo
Inclusion criteria:
* Diagnosis typ 2 diabetes mellitus
* Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation
* HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1
* 18 years or more
* BMI equal or less than 45Kg/m2
Exclusion criteria:
* Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in
* Any other antidiabetic drug within 12 weeks prior to randomisation except metformin
* Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent
* Indication of liver disease
* Moderate to severe renal impairment
* Bariatric surgery within past 2 years
* Medical history of cancer or treatment for cancer within last 5 years
* Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
* Contraindications hypersensitivity to concomitant drugs
* Treatment with anti-obesity drugs
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
25 Locations
Phoenix
1245.28.10005 Boehringer Ingelheim Investigational Site
Arizona, United States
Phoenix
1245.28.10012 Boehringer Ingelheim Investigational Site
Arizona, United States
Hot Springs
1245.28.10016 Boehringer Ingelheim Investigational Site
Arkansas, United States
Sacramento
1245.28.10003 Boehringer Ingelheim Investigational Site
California, United States
West Hills
1245.28.10021 Boehringer Ingelheim Investigational Site
California, United States
Bradednton
1245.28.10009 Boehringer Ingelheim Investigational Site
Florida, United States
Tampa
1245.28.10015 Boehringer Ingelheim Investigational Site
Florida, United States
Blue Ridge
1245.28.10033 Boehringer Ingelheim Investigational Site
Georgia, United States
Boise
1245.28.10026 Boehringer Ingelheim Investigational Site
Idaho, United States
Omaha
1245.28.10007 Boehringer Ingelheim Investigational Site
Nebraska, United States
Henderson
1245.28.10027 Boehringer Ingelheim Investigational Site
Nevada, United States
Rochester
1245.28.10014 Boehringer Ingelheim Investigational Site
New York, United States
Shelby
1245.28.10006 Boehringer Ingelheim Investigational Site
North Carolina, United States
Cincinnati
1245.28.10011 Boehringer Ingelheim Investigational Site
Ohio, United States
Cincinnati
1245.28.10019 Boehringer Ingelheim Investigational Site
Ohio, United States
Columbus
1245.28.10004 Boehringer Ingelheim Investigational Site
Ohio, United States
Perrysburg
1245.28.10008 Boehringer Ingelheim Investigational Site
Ohio, United States
Medford
1245.28.10020 Boehringer Ingelheim Investigational Site
Oregon, United States
Portland
1245.28.10017 Boehringer Ingelheim Investigational Site
Oregon, United States
Dallas
1245.28.10031 Boehringer Ingelheim Investigational Site
Texas, United States
Longview
1245.28.10032 Boehringer Ingelheim Investigational Site
Texas, United States
San Antonio
1245.28.10022 Boehringer Ingelheim Investigational Site
Texas, United States
Draper
1245.28.10030 Boehringer Ingelheim Investigational Site
Utah, United States
Salt Lake City
1245.28.10023 Boehringer Ingelheim Investigational Site
Utah, United States
Kenosha
1245.28.10013 Boehringer Ingelheim Investigational Site
Wisconsin, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov