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

Tracking Information

First Received Date ^ICMJE

January 7, 2009

Last Updated Date

November 23, 2009

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

The change from baseline in HbA1c (HbA1c after 18 weeks of treatment). [ Time Frame: 18 Weeks of treatment ]

Change History

Complete list of historical versions of study NCT00819091 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: BI 1356
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

246

Completion Date

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Hungary, India, Japan, Poland, Russian Federation

Administrative Information

NCT ID ^ICMJE

NCT00819091

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

1218.35, EUDRACT2008-003118-86

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP