Efficacy and Safety of BI 1356 BS in Combination With Metformin in Patients With type2 Diabetes

This study has been completed.

First Received: March 31, 2006 Last Updated: January 27, 2009 History of Changes

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00309608

Purpose

The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: BI 1356 BS Drug: Glimepiride	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Randomised, Double-Blind, Placebo-Controlled, Five Parallel Groups Study Investigating the Efficacy and Safety of BI 1356 BS (1 mg, 5 mg and 10 mg Administered Orally Once Daily) Over 12 Weeks as Add-on Therapy in Patients With Type 2 Diabetes and Insufficient Glycaemic Control Despite Metformin Therapy, Including an Open-Label Glimepiride Treatment Arm.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride Metformin

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Enrollment:	333
Study Start Date:	April 2006
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
HbA1c 7.0 9.0% at screening for patients treated with metformin and one other oral antidiabetic drug
HbA1c 7.5 10.0% at screening for patients treated with metformin alone
HbA1c 7.5 10.0% at beginning of the placebo run-in phase
Age > 21 and < 75 years
BMI > 25 and < 40 kg/m2 (Body Mass Index)

Exclusion Criteria:

Clinically relevant cardiovascular disease
Impaired hepatic function
Renal insufficiency or impaired renal function
Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
Treatment with insulin within 3 months prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309608

Show 48 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1218.6
Study First Received:	March 31, 2006
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00309608 History of Changes
Health Authority:	France: AFSSAPS; Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte; Great Britain: MHRA; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; Sweden: Medical Products Agency; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 09, 2010