Randomized, db, Placebo-controlled 18 Week Study of BI 1356 in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug

This study is ongoing, but not recruiting participants.

First Received: January 7, 2009 Last Updated: November 23, 2009 History of Changes

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00819091

Purpose

Efficacy and safety of BI 1356 compared to placebo in patients with type 2 diabetes who have insufficient glycaemic control despite treatment with a sulfonylurea drug.

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

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-blind, Placebo-controlled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 18 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control (HbA1c 7.0-10%) Despite Background Therapy With a Sulfonylurea Drug.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

The primary efficacy endpoint is change from baseline HbA1c after 18 weeks of treatment. [ Time Frame: 18 Weeks of treatment ]

Secondary Outcome Measures:

HbA1c <7.0% after 18 weeks of treatment [ Time Frame: 18 Weeks of treatment ]

Estimated Enrollment:	246
Study Start Date:	December 2008
Estimated Primary Completion Date:	January 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%) despite therapy with a sulfonylurea drug

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819091

Show 45 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:	1218.35, EUDRACT2008-003118-86
Study First Received:	January 7, 2009
Last Updated:	November 23, 2009
ClinicalTrials.gov Identifier:	NCT00819091 History of Changes
Health Authority:	Argentina: ANMAT (Food, Drug and Medical Technology National Administration); Hungary: National Institute of Pharmacy; India: Drugs Controller General India; Japan: Ministry of Health, Labor and Welfare; Poland:; Russia: Pharmacological Committee, Ministry of Health; United States: Food and Drug Administration

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009