Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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

Key facts

Study ID

NCT00622284

Run by

Boehringer Ingelheim

People needed

1560

Starts

2008-02-01

Last updated by the study team

2014-01-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Glycosylated haemoglobin (HbA1c) 6.0 - 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
• HbA1c 6.5 - 10.0% at screening for patients treated with metformin alone
• HbA1c 6.5 - 10.0% at beginning of the placebo run-in phase

You may not qualify if…

• Myocardial infarction, stroke or transient ischemic attack (TIA)
• Impaired hepatic function
• Renal failure or renal impairment
• Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
• Treatment with insulin or glucagon-like peptide 1 (GLP-1) analogue/antagonists within 3 months prior to screening

Where it is running

• 1218.20.10003 Boehringer Ingelheim Investigational Site — Chula Vista, California, United States
• 1218.20.10020 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1218.20.10035 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1218.20.10037 Boehringer Ingelheim Investigational Site — Los Gatos, California, United States
• 1218.20.10034 Boehringer Ingelheim Investigational Site — West Palm Beach, Florida, United States
• 1218.20.10023 Boehringer Ingelheim Investigational Site — Indianapolis, Indiana, United States
• 1218.20.10030 Boehringer Ingelheim Investigational Site — Topeka, Kansas, United States
• 1218.20.10028 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
• 1218.20.10006 Boehringer Ingelheim Investigational Site — Omaha, Nebraska, United States
• 1218.20.10022 Boehringer Ingelheim Investigational Site — Endwell, New York, United States
• 1218.20.10032 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
• 1218.20.10031 Boehringer Ingelheim Investigational Site — Columbus, Ohio, United States
• 1218.20.10013 Boehringer Ingelheim Investigational Site — Mentor, Ohio, United States
• 1218.20.10045 Boehringer Ingelheim Investigational Site — Perrysburg, Ohio, United States
• 1218.20.10042 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 1218.20.10024 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 1218.20.10002 Boehringer Ingelheim Investigational Site — Greer, South Carolina, United States
• 1218.20.10007 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1218.20.10036 Boehringer Ingelheim Investigational Site — Murray, Utah, United States
• 1218.20.10029 Boehringer Ingelheim Investigational Site — Salt Lake City, Utah, United States
• 1218.20.10009 Boehringer Ingelheim Investigational Site — Federal Way, Washington, United States
• 1218.20.10026 Boehringer Ingelheim Investigational Site — Renton, Washington, United States
• 1218.20.35201 Boehringer Ingelheim Investigational Site — Sofia, Bulgaria
• 1218.20.35202 Boehringer Ingelheim Investigational Site — Sofia, Bulgaria
• 1218.20.10033 Boehringer Ingelheim Investigational Site — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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