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12 Weeks Treatement With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, December 2008
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00789035
  Purpose

The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: BI 10773
Drug: placebo
Drug: metformin
Phase II

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 IIb, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (5 mg, 10 mg and 25 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo, as Monotherapy, With an Additional Open-Label Metformin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint is change in HbA1c from baseline after 12 weeks of treatment [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • The main secondary endpoints are: 1. Change in FPG from baseline through 12 weeks of treatment 2. Change in HbA1c from baseline over time 3. Pharmocokinetics of BI 10773 [ Time Frame: 12 weeks ]

Estimated Enrollment: 450
Study Start Date: October 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:

  • Male and female patients with a diagnosis of type 2 diabetes mellitus
  • HbA1c between 7% and 10%
  • Age between 18 and 80 years
  • BMI less than 40 kg/m2
  • Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion Criteria:

  1. Myocardial infarction, stroke or TIA within 6 months prior to informed consent
  2. Impaired hepatic function
  3. Renal insufficiency or impaired renal function
  4. Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
  5. Chronic or clinically relevant acute infections
  6. Current or chronic urogenital tract infection determined by medical history
  7. History of clinically relevant allergy/hypersensitivity
  8. Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
  9. Treatment with anti obesity drugs
  10. Current treatment with systemic steroids
  11. Alcohol abuse
  12. Treatment with an investigational drug within 2 months prior to informed consent
  13. Intolerance to metfomin
  14. Dehydration
  15. Unstable or acute CHF
  16. Acute or chronic acidosis
  17. Hereditary galactose intolerance
  18. Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789035

Contacts
Contact: Boehringer Ingelheim Study Coordinator 800-542-6257 ext Option 4 clintriage.rdg@boehringer-ingelheim.com

Locations
Estonia
1245.9.37201 Boehringer Ingelheim Investigational Site Not yet recruiting
Tallin, Estonia
1245.9.37202 Boehringer Ingelheim Investigational Site Not yet recruiting
Tallin, Estonia
1245.9.37203 Boehringer Ingelheim Investigational Site Not yet recruiting
Tallin, Estonia
Italy
1245.9.39005 Boehringer Ingelheim Investigational Site Not yet recruiting
Treviso, Italy
1245.9.39003 Boehringer Ingelheim Investigational Site Recruiting
Pisa, Italy
1245.9.39004 Boehringer Ingelheim Investigational Site Not yet recruiting
Siena, Italy
1245.9.39001 Boehringer Ingelheim Investigational Site Recruiting
Pisa, Italy
1245.9.39006 Boehringer Ingelheim Investigational Site Not yet recruiting
Genova, Italy
Korea, Republic of
1245.9.82001 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1245.9.82002 Boehringer Ingelheim Investigational Site Recruiting
Pucheon, Korea, Republic of
1245.9.82003 Boehringer Ingelheim Investigational Site Recruiting
Uijeongbu, Korea, Republic of
1245.9.82006 Boehringer Ingelheim Investigational Site Recruiting
Goyang, Korea, Republic of
1245.9.82005 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1245.9.82004 Boehringer Ingelheim Investigational Site Recruiting
Seoul, Korea, Republic of
1245.9.82007 Boehringer Ingelheim Investigational Site Recruiting
Incheon, Korea, Republic of
1245.9.82008 Boehringer Ingelheim Investigational Site Recruiting
Goyang, Korea, Republic of
1245.9.82009 Boehringer Ingelheim Investigational Site Recruiting
Suwon, Korea, Republic of
Sweden
1245.9.46001 Boehringer Ingelheim Investigational Site Not yet recruiting
Stockholm, Sweden
1245.9.46005 Boehringer Ingelheim Investigational Site Not yet recruiting
Svedala, Sweden
1245.9.46004 Boehringer Ingelheim Investigational Site Recruiting
Härnösand, Sweden
1245.9.46003 Boehringer Ingelheim Investigational Site Not yet recruiting
Göteborg, Sweden
1245.9.46002 Boehringer Ingelheim Investigational Site Recruiting
Västerås, Sweden
Taiwan
1245.9.88607 Boehringer Ingelheim Investigational Site Recruiting
Kaohsiung, Taiwan
1245.9.88602 Boehringer Ingelheim Investigational Site Recruiting
Taoyuan, Taiwan
1245.9.88603 Boehringer Ingelheim Investigational Site Recruiting
Taipei, Taiwan
1245.9.88604 Boehringer Ingelheim Investigational Site Recruiting
Taichung, Taiwan
1245.9.88605 Boehringer Ingelheim Investigational Site Recruiting
Changhua, Taiwan
1245.9.88606 Boehringer Ingelheim Investigational Site Recruiting
Tainan, Taiwan
1245.9.88601 Boehringer Ingelheim Investigational Site Recruiting
Taipei, Taiwan
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: 1245.9, EudraCT No 2008-000640-14
Study First Received: October 13, 2008
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00789035  
Health Authority: Argentina: A.N.M.A.T. (National Administration of Medications, Food and Medical Technology);   Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb;   Estonia: State Agency of Medicines, EE-5041Tartu;   Germany: Federal Institute for Drugs and Medical Devices;   Italy: Comitato per la Sperimentazione Clinica dei Medicinali Azienda Ospedaliero-Universitaria Pisana;   Korea, Republic of: Korea Food and Drug Administration (KFDA);   Lithuania: State Medicines Control Agency, LT-01132 Vilnius;   Romania: National Medicines Agency, Bucharest;   Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow;   Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26;   Sweden: Medical Products Agency, Box 26, 751 03 Uppsala, Sweden Regional Ethical Review Board of Stockholm, PO Box 289, SE-171 77 Stockholm, Sweden.;   Taiwan: Department of Health, Executive Yuan, Taiwan;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

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