A Randomised Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of BI 1356 ( 5.0 mg, Administered Orally Once Daily) Compared to Glimepiride Over Two Years in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy
- NCT00622284
- PHASE3
- INTERVENTIONAL
Last updated: 2014-01-29
Purpose of Trial
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
This study is for people with
Diabetes Mellitus, Type 2
Interventions being studied
Placebo identical to BI 1356 5mg
Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg
BI 1356
Glimepiride
Inclusion criteria:
1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug
2. Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
3. HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
4. HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase
Exclusion criteria:
1. Myocardial infarction, stroke or transient ischemic attack (TIA)
2. Impaired hepatic function
3. Renal failure or renal impairment
4. Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
5. Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening
ELIGIBILITY
Gender: ALL
Age: 18+
Healthy Volunteers: No
23 Locations
Tempe
1218.20.10033 Boehringer Ingelheim Investigational Site
Arizona, United States
Chula Vista
1218.20.10003 Boehringer Ingelheim Investigational Site
California, United States
Los Angeles
1218.20.10020 Boehringer Ingelheim Investigational Site
California, United States
Los Angeles
1218.20.10035 Boehringer Ingelheim Investigational Site
California, United States
Los Gatos
1218.20.10037 Boehringer Ingelheim Investigational Site
California, United States
West Palm Beach
1218.20.10034 Boehringer Ingelheim Investigational Site
Florida, United States
Indianapolis
1218.20.10023 Boehringer Ingelheim Investigational Site
Indiana, United States
Topeka
1218.20.10030 Boehringer Ingelheim Investigational Site
Kansas, United States
St. Louis
1218.20.10028 Boehringer Ingelheim Investigational Site
Missouri, United States
Omaha
1218.20.10006 Boehringer Ingelheim Investigational Site
Nebraska, United States
Endwell
1218.20.10022 Boehringer Ingelheim Investigational Site
New York, United States
Cincinnati
1218.20.10032 Boehringer Ingelheim Investigational Site
Ohio, United States
Columbus
1218.20.10031 Boehringer Ingelheim Investigational Site
Ohio, United States
Mentor
1218.20.10013 Boehringer Ingelheim Investigational Site
Ohio, United States
Perrysburg
1218.20.10045 Boehringer Ingelheim Investigational Site
Ohio, United States
Oklahoma City
1218.20.10042 Boehringer Ingelheim Investigational Site
Oklahoma, United States
Philadelphia
1218.20.10024 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Greer
1218.20.10002 Boehringer Ingelheim Investigational Site
South Carolina, United States
San Antonio
1218.20.10007 Boehringer Ingelheim Investigational Site
Texas, United States
Murray
1218.20.10036 Boehringer Ingelheim Investigational Site
Utah, United States
Salt Lake City
1218.20.10029 Boehringer Ingelheim Investigational Site
Utah, United States
Federal Way
1218.20.10009 Boehringer Ingelheim Investigational Site
Washington, United States
Renton
1218.20.10026 Boehringer Ingelheim Investigational Site
Washington, 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