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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00789035 |
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 |
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 |
Estimated Enrollment: | 450 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Boehringer Ingelheim Study Coordinator | 800-542-6257 ext Option 4 | clintriage.rdg@boehringer-ingelheim.com |
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 |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
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) |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |