Efficacy and Safety of B I1356 vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00601250

Purpose

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 add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: BI 1356 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 Randomised, Double-Blind, Placebo-Controlled Parallel Group Efficacy and Safety Study of BI 1356 (One Dose, e.g. 5 mg), Administered Orally Once Daily Over 24 Weeks, With an Open Label Extension to 80 Weeks (Placebo Patients Switched to BI 1356), in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

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:

change from baseline in HbA1c, change from baseline in FPG, Change from baseline in Postprandial glucose [ Time Frame: 24 weeks ]

Estimated Enrollment:	600
Study Start Date:	January 2008
Estimated Primary Completion Date:	May 2009 (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:

Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone, or with metformin and not more than one other oral antidiabetic drug
Diagnosis of type 2 diabetes prior to informed consent
Glycosylated haemoglobin A1 (HbA1c)at screening:

For patients undergoing wash out of previous medication: HbA1c 6.5 - 9.0% For patients not undergoing wash-out of previous medication: HbA1c 7.0 - 10.0%
Glycosylated haemoglobin A1 (HbA1c) 7.0 - 10.0% at the beginning of Placebo Run-in
Age 18 -80 years
BMI (Body Mass Index) less than 40 kg/m2
Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

Exclusion Criteria:

Myocardial infarction, stroke or TIA within 6 months prior to informed consent
Impaired hepatic function
Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
Treatment with an injectable GLP-1 analogue (e.g. exenatide) within 3 months prior to informed consent
Treatment with insulin within 3 months prior to informed consent
Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
Participation in another trial with an investigational drug within 2 months prior to informed consent
Pre-menopausal women who:
- are nursing or pregnant,
- or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
Renal failure or renal impairment
Unstable or acute congestive heart failure
Acute or chronic metabolic acidosis (present in patient history)
Hereditary galactose intolerance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601250

Show 83 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:	1218.17, EudraCT No.: 2007-002457-24
Study First Received:	January 15, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00601250
Health Authority:	Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Finland: National Agency for Medicines; Greece: National Organization of Medicines (EOF) National Ethics Committee; India: Ministry of Health and Family Welfare; Israel: Ministry of Health; Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS); New Zealand: Multicentre Ethics Committee/Medsafe; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Sweden: Sweden; Läkemedelsverket (Medical Product Agency); United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on January 16, 2009