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

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00819091

Purpose

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

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

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	255
Study Start Date:	December 2008
Estimated Primary Completion Date:	October 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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819091

Contacts

Contact: Boehringer Ingelheim Study Coordinator

800-542-6257 ext Option 4

clintriage.rdg@boehringer-ingelheim.com

Locations

United States, Alabama
1218.35.10002 Boehringer Ingelheim Investigational Site	Not yet recruiting
Birmingham, Alabama, United States
United States, California
1218.35.10001 Boehringer Ingelheim Investigational Site	Recruiting
Los Angeles, California, United States
United States, Indiana
1218.35.10006 Boehringer Ingelheim Investigational Site	Not yet recruiting
Indianapolis, Indiana, United States
United States, Louisiana
1218.35.10008 Boehringer Ingelheim Investigational Site	Not yet recruiting
New Orleans, Louisiana, United States
United States, Ohio
1218.35.10004 Boehringer Ingelheim Investigational Site	Recruiting
Cincinnati, Ohio, United States
United States, Oregon
1218.35.10005 Boehringer Ingelheim Investigational Site	Not yet recruiting
Portland, Oregon, United States
United States, Texas
1218.35.10009 Boehringer Ingelheim Investigational Site	Not yet recruiting
Dallas, Texas, United States
Argentina
1218.35.54001 Boehringer Ingelheim Investigational Site	Not yet recruiting
Mar del Plata, Argentina
1218.35.54002 Boehringer Ingelheim Investigational Site	Not yet recruiting
Córdoba, Argentina
1218.35.54003 Boehringer Ingelheim Investigational Site	Not yet recruiting
Capital Federal, Argentina
1218.35.54004 Boehringer Ingelheim Investigational Site	Not yet recruiting
Córdoba, Argentina
1218.35.54005 Boehringer Ingelheim Investigational Site	Not yet recruiting
Corrientes, Argentina
1218.35.54006 Boehringer Ingelheim Investigational Site	Not yet recruiting
Parque Velez Sarfield, Argentina
Japan
1218.35.81001 Boehringer Ingelheim Investigational Site	Recruiting
Shinjyuku-ku,Tokyo, Japan
1218.35.81002 Boehringer Ingelheim Investigational Site	Recruiting
Suita, Osaka,, Japan
1218.35.81003 Boehringer Ingelheim Investigational Site	Recruiting
Osaka, Osaka, Japan

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:	1218.35, EUDRACT20080-003118-86
Study First Received:	January 7, 2009
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00819091
Health Authority:	Argentina: ANMAT (Food, Drug and Medical Technology National Administration); Hungary: National Institute of Pharmacy, H-1051 Budapest; India: Drugs Controller General India; Japan: Ministry of Health, Labor and Welfare; Poland: CEBK, Warsaw; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; 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