A Randomised, db, Placebo-Controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-Blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate

This study is currently recruiting participants.

Verified by Boehringer Ingelheim Pharmaceuticals, December 2008

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00740051

Purpose

Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is inappropriate (intolerability, contraindication). The second part of the study looks at the safety of BI 1356 in this patient population with longer term treatment in comparison to a sulfonylurea drug (glimepiride).

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: BI 1356 Drug: Glimepiride Drug: placebo	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Glimepiride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised, db, Placebo-Controlled, Parallel Group Efficacy and Safety Study of BI 1356 (5mg), Administered Orally Once Daily for 18 Weeks Followed by a 34 Week Double-Blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients With Insufficient Glycaemic Control for Whom Metformin Therapy is Inappropriate (Intolerability or Contraindication)

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary endpoint in this study is the change from baseline in HbA1c after 18 weeks of treatment. [ Time Frame: 18 weeks ]

Secondary Outcome Measures:

Key secondary endpoint is safety in this patient population with longer term (34 week) treatment in comparison to a sulfonylurea drug (glimepiride) [ Time Frame: 52 weeks ]

Estimated Enrollment:	225
Study Start Date:	August 2008
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)

Exclusion Criteria:

Myocardial infarction, stroke or Transient ischaemic attack in last 6 months
Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months
Impaired hepatic function
Severe renal impairment
Current treatment with systemic steroids
Change in dosage of thyroid hormones
Hereditary galactose intolerance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740051

Contacts

Contact: Boehringer Ingelheim Study Coordinator

800-542-6257 ext Option 4

clintriage.rdg@boehringer-ingelheim.com

Show 39 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1218.50, EUDRACT2007-007485-38
Study First Received:	August 21, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00740051
Health Authority:	Canada: Health Canada, Therapeutic Products Directorate; Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS); Philippines: Bureau of Food and Drug; Romania: National Medicines Agency, Bucharest; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration

Study placed in the following topic categories:

Glimepiride
Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs

Cardiovascular Agents
Anti-Arrhythmia Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009