Efficacy and Safety of BI 1356 Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control

This study is ongoing, but not recruiting participants.

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00621140

Purpose

To investigate efficacy, safety and tolerability of BI 1356 versus placebo

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

MedlinePlus related topics: Diabetes

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Efficacy Study
Official Title:	A Randomised, Double-Blind, Placebo-Controled Parallel Group Efficacy and Safety Study of BI 1356 (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug Naive or Previously Treated (6 Weeks Washout) Type 2 Diabetic Patients With Insufficient Glycemic Control

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 (HbA1c after 24 weeks of treatment). [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

Other HbA1c related parameters fasting plasma glucose. 2 hour post prandial glucose [ Time Frame: 24 weeks ]

Estimated Enrollment:	503
Study Start Date:	February 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Male or female patients with type 2 diabetes and insufficient glycaemic control.
Age 18 or over and not older than 80 years

Exclusion Criteria:

Use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or GLP-1 analogues within 3 months.
Myocardial infarction, stroke or TIA within 6 months prior to informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621140

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:	1218.16, Eudract 2007-002448-10
Study First Received:	January 14, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00621140
Health Authority:	Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb; India: Drug Control General of India; Israel: No regulatory agency approval needed for clinical trials; Italy: Comitato Etico per la sperim. clinica dei medicinali dell'A.O. Universitaria Pisana di Pisa; Malaysia: Ministry of Health, Malaysia; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Poland: Urzad Rejestracji Produktow Leczniczych, Wyrobow, Medycznych i Produktow Biobojczych, PL-00725 Warsaw; Romania: National Medicines Agency, Bucharest; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; Thailand: Ministry of Public Health; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009