Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00641043 |
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: BI 1356 Drug: Placebo Drug: Pioglitazone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Efficacy Study |
Official Title: | A Randomised, Double-Blind, Placebo Controlled, Parallel Group 24 Week Study to Assess the Efficacy and Safety of BI 1356 (5 mg) in Combination With 30 mg Pioglitazone (Both Administered Orally Once Daily), Compared to 30 mg Pioglitazone Plus Placebo in Drug Naive or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control. |
Estimated Enrollment: | 375 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Pre-menopausal women (last menstruation < or =1 year prior to signing IC) who:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1218.15, EudraCT 2007-002456-41 |
Study First Received: | February 29, 2008 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00641043 History of Changes |
Health Authority: | Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna; Greece: National Organization fo Medicines (EOF) National Ethics Committe; Hungary: National Institute of Pharmacy, H-1051 Budapest; Japan: Ministry of Health, Labor and Welfare; Portugal: INFARMED I.P.; Romania: National Medicines Agency, Bucharest; Spain: AEMPS; United States: Food and Drug Administration |
Hypoglycemic Agents Metabolic Diseases Pioglitazone Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Metabolic Diseases Pioglitazone Physiological Effects of Drugs Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |