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Randomized, db, Placebo-controlled 18 Week Study of BI 1356 in Type 2 Diabetic Patients With Insufficient Glycaemic Control on a Sulfonylurea Drug
This study is ongoing, but not recruiting participants.
First Received: January 7, 2009   Last Updated: November 23, 2009   History of Changes
Sponsor: 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

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.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

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: 246
Study Start Date: December 2008
Estimated Primary Completion Date: January 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 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

  Hide Study Locations
Locations
United States, Alabama
1218.35.10002 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, California
1218.35.10001 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1218.35.10016 Boehringer Ingelheim Investigational Site
National City, California, United States
United States, Florida
1218.35.10017 Boehringer Ingelheim Investigational Site
Ft. Lauderdale, Florida, United States
1218.35.10021 Boehringer Ingelheim Investigational Site
Ft. Lauderdale, Florida, United States
United States, Illinois
1218.35.10013 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Michigan
1218.35.10015 Boehringer Ingelheim Investigational Site
Flint, Michigan, United States
United States, North Carolina
1218.35.10018 Boehringer Ingelheim Investigational Site
Asheville, North Carolina, United States
United States, Ohio
1218.35.10004 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
United States, Oregon
1218.35.10005 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, South Carolina
1218.35.10020 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
United States, Texas
1218.35.10009 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
1218.35.10019 Boehringer Ingelheim Investigational Site
Sugar Land, Texas, United States
Argentina
1218.35.54001 Boehringer Ingelheim Investigational Site
Mar Del Plata, Argentina
1218.35.54003 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1218.35.54005 Boehringer Ingelheim Investigational Site
Corrientes, Argentina
1218.35.54006 Boehringer Ingelheim Investigational Site
Parque Velez Sarfield, Argentina
Hungary
1218.35.36005 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1218.35.36002 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1218.35.36003 Boehringer Ingelheim Investigational Site
Debrecen, Hungary
1218.35.36004 Boehringer Ingelheim Investigational Site
Budapest, Hungary
1218.35.36001 Boehringer Ingelheim Investigational Site
Budapest, Hungary
India
1218.35.91001 Boehringer Ingelheim Investigational Site
Bangalore, Karnataka, India
1218.35.91002 Boehringer Ingelheim Investigational Site
Indore, India
1218.35.91003 Boehringer Ingelheim Investigational Site
Aligarh, Uttar Pradesh, India
1218.35.91004 Boehringer Ingelheim Investigational Site
Bangalore, Karnataka, India
1218.35.91005 Boehringer Ingelheim Investigational Site
Nagpur, Maharashtra, India
1218.35.91006 Boehringer Ingelheim Investigational Site
Pune, Maharastra, India
1218.35.91007 Boehringer Ingelheim Investigational Site
Aminjikarai, Tamilnadu, India
1218.35.91008 Boehringer Ingelheim Investigational Site
Mumbai, Maharastra, India
Japan
1218.35.81001 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo, Japan
1218.35.81002 Boehringer Ingelheim Investigational Site
Suita, Osaka,, Japan
1218.35.81003 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
Poland
1218.35.48001 Boehringer Ingelheim Investigational Site
Rzeszow, Poland
1218.35.48002 Boehringer Ingelheim Investigational Site
Bialystok, Poland
1218.35.48003 Boehringer Ingelheim Investigational Site
Poznan, Poland
1218.35.48004 Boehringer Ingelheim Investigational Site
Lublin, Poland
1218.35.48005 Boehringer Ingelheim Investigational Site
Wroclaw, Poland
Russian Federation
1218.35.70001 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1218.35.70002 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1218.35.70009 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1218.35.70006 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1218.35.70007 Boehringer Ingelheim Investigational Site
Yaroslavl, Russian Federation
1218.35.70008 Boehringer Ingelheim Investigational Site
Arkhangelsk, Russian Federation
1218.35.70003 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1218.35, EUDRACT2008-003118-86
Study First Received: January 7, 2009
Last Updated: November 23, 2009
ClinicalTrials.gov Identifier: NCT00819091     History of Changes
Health Authority: Argentina: ANMAT (Food, Drug and Medical Technology National Administration);   Hungary: National Institute of Pharmacy;   India: Drugs Controller General India;   Japan: Ministry of Health, Labor and Welfare;   Poland:;   Russia: Pharmacological Committee, Ministry of Health;   United States: Food and Drug Administration

Additional relevant MeSH terms:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009



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