Safety and Efficacy of BI 1356 Plus Metformin in Type 2 Diabetes, Factorial Design - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00798161

Purpose

The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

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

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Randomised, Double-Blind, Placebo-Controlled Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Free Combination of BI 1356 2.5 mg + Metformin 500 mg, or of BI 1356 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg Twice Daily), and BI 1356 (5.0 mg Once Daily) Over 24 Weeks in Drug Naive or Previously Treated (4 Weeks Wash-Out and 2 Weeks Placebo Run-in) Type 2 Diabetic Patients With Insufficient Glycaemic Control

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

HbA1c change from baseline after 24 weeks [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

Individual efficacy respond in terms of HbA1c less than 7.0 % and less than 6.5 % after treatment of 24 weeks, HbA1c reduction from baseline by visit over time [ Time Frame: 24 weeks ]

Estimated Enrollment:	800
Study Start Date:	November 2008
Estimated Primary Completion Date:	March 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 with type 2 diabetes (drug naive or pre-treated) with insufficient glycaemic control (HbA1c higher or equal than 7.5 to less than 11.0 %), with very poor glycaemic control (HbA1c higher or equal than 11.0 %) who are not eligible for randomisation to be included in the open-label arm

Exclusion Criteria:

Myocardial infarction
Stroke or TIA
Unstable or acute congestive heart failure
Impaired hepatic function
Treatment with rosiglitazone or pioglitazone, with a GLP1 analogue, with insulin, with anti-obesity drugs, with stystemic steroids
Renal failure or impairment
Gastric bypass

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798161

Contacts

Contact: Boehringer Ingelheim Study Coordinator

clintriage.rdg@boehringer-ingelheim.com

Show 62 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:	1218.46, EudraCT no: 2008-001640-40
Study First Received:	November 24, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00798161
Health Authority:	Estonia: State Agency of Medicines, EE-5041Tartu; Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb; Lithuania: State Medicines Control Agency, LT-01132 Vilnius; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Romania: National Medicines Agency, Bucharest; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); Brazil: National Health Surveillance Agency; Canada: Health Canada, Therapeutic Products Directorate; Germany: BfArM-Federal Authorities for Drugs and Medical Devices; France: Agence Française de Sécurité Sanitaire des Produits de Santé; Tunasia: Direction de la Pharmacie et du Médicament (DPM); Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS); Netherlands: Central Committee on Research Involving Human Subjects (CCMO); India: Drug Control General of India; Sweden: Medical Products Agency; Sweden: Regional Ethics Committee of Uppsala; South Africa: Medicines Control Council

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009