12 Weeks Treatement With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
Overview[ - collapse ][ - ]
| 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 | Diabetes Mellitus, Type 2 |
| Intervention | Drug: BI 10773 Drug: placebo Drug: metformin |
| Phase | Phase 2 |
| Sponsor | Boehringer Ingelheim |
| Responsible Party | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier | NCT00789035 |
| First Received | October 13, 2008 |
| Last Updated | July 10, 2013 |
| Last verified | July 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 13, 2008 |
|---|---|
| Last Updated Date | July 10, 2013 |
| Start Date | October 2008 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Change of HbA1c from baseline after 12 weeks of treatment [Time Frame: 12 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | 12 Weeks Treatement With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients |
|---|---|
| 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 |
| Brief Summary | 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 |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: BI 10773 Drug: placebo Drug: metformin |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 408 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | October 2009 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Argentina, Croatia, Estonia, Germany, Italy, Korea, Republic of, Lithuania, Romania, Russian Federation, Slovakia, Sweden, Taiwan, Ukraine |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00789035 |
|---|---|
| Other Study ID Numbers | 1245.9 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Boehringer Ingelheim |
| Study Sponsor | Boehringer Ingelheim |
| Collaborators | Not Provided |
| Investigators | Study Chair: Boehringer Ingelheim Boehringer Ingelheim |
| Verification Date | July 2013 |
Locations[ + expand ][ + ]
| 1245.9.54001 Boehringer Ingelheim Investigational Site | Capital Federal, Argentina |
|---|---|
| 1245.9.54002 Boehringer Ingelheim Investigational Site | Capital Federal, Argentina |
| 1245.9.54009 Boehringer Ingelheim Investigational Site | Capital Federal, Argentina |
| 1245.9.54007 Boehringer Ingelheim Investigational Site | Capital Federal, Argentina |
| 1245.9.54008 Boehringer Ingelheim Investigational Site | Capital Federal, Argentina |
| 1245.9.54010 Boehringer Ingelheim Investigational Site | Capital Federal, Argentina |
| 1245.9.54004 Boehringer Ingelheim Investigational Site | Mar del Plata, Argentina |
| 1245.9.54003 Boehringer Ingelheim Investigational Site | Mendoza, Argentina |
| 1245.9.54005 Boehringer Ingelheim Investigational Site | Salta, Argentina |
| 1245.9.54006 Boehringer Ingelheim Investigational Site | Salta, Argentina |
| 1245.9.38504 Boehringer Ingelheim Investigational Site | Karlovac, Croatia |
| 1245.9.38503 Boehringer Ingelheim Investigational Site | Krapinske Toplice, Croatia |
| 1245.9.38506 Boehringer Ingelheim Investigational Site | Osijek, Croatia |
| 1245.9.38505 Boehringer Ingelheim Investigational Site | Varazdin, Croatia |
| 1245.9.38501 Boehringer Ingelheim Investigational Site | Zagreb, Croatia |
| 1245.9.37201 Boehringer Ingelheim Investigational Site | Tallin, Estonia |
| 1245.9.37202 Boehringer Ingelheim Investigational Site | Tallin, Estonia |
| 1245.9.37203 Boehringer Ingelheim Investigational Site | Tallin, Estonia |
| 1245.9.49007 Boehringer Ingelheim Investigational Site | Aschaffenburg, Germany |
| 1245.9.49001 Boehringer Ingelheim Investigational Site | Erlangen, Germany |
| 1245.9.49004 Boehringer Ingelheim Investigational Site | Hamburg, Germany |
| 1245.9.49005 Boehringer Ingelheim Investigational Site | Hamburg, Germany |
| 1245.9.49002 Boehringer Ingelheim Investigational Site | Melsungen, Germany |
| 1245.9.49008 Boehringer Ingelheim Investigational Site | Nürnberg, Germany |
| 1245.9.49003 Boehringer Ingelheim Investigational Site | St. Ingbert/Oberwürzbach, Germany |
| 1245.9.49006 Boehringer Ingelheim Investigational Site | Sulzbach-Rosenberg, Germany |
| 1245.9.39006 Boehringer Ingelheim Investigational Site | Genova, Italy |
| 1245.9.39001 Boehringer Ingelheim Investigational Site | Pisa, Italy |
| 1245.9.39003 Boehringer Ingelheim Investigational Site | Pisa, Italy |
| 1245.9.39004 Boehringer Ingelheim Investigational Site | Siena, Italy |
| 1245.9.39005 Boehringer Ingelheim Investigational Site | Treviso, Italy |
| 1245.9.82006 Boehringer Ingelheim Investigational Site | Goyang, Korea, Republic of |
| 1245.9.82008 Boehringer Ingelheim Investigational Site | Goyang, Korea, Republic of |
| 1245.9.82007 Boehringer Ingelheim Investigational Site | Incheon, Korea, Republic of |
| 1245.9.82002 Boehringer Ingelheim Investigational Site | Pucheon, Korea, Republic of |
| 1245.9.82004 Boehringer Ingelheim Investigational Site | Seoul, Korea, Republic of |
| 1245.9.82005 Boehringer Ingelheim Investigational Site | Seoul, Korea, Republic of |
| 1245.9.82001 Boehringer Ingelheim Investigational Site | Seoul, Korea, Republic of |
| 1245.9.82009 Boehringer Ingelheim Investigational Site | Suwon, Korea, Republic of |
| 1245.9.82003 Boehringer Ingelheim Investigational Site | Uijeongbu, Korea, Republic of |
| 1245.9.37002 Boehringer Ingelheim Investigational Site | Klaipeda, Lithuania |
| 1245.9.37001 Boehringer Ingelheim Investigational Site | Vilnius, Lithuania |
| 1245.9.40003 Boehringer Ingelheim Investigational Site | Brasov, Romania |
| 1245.9.40002 Boehringer Ingelheim Investigational Site | Bucharest, Romania |
| 1245.9.40004 Boehringer Ingelheim Investigational Site | Galati, Romania |
| 1245.9.40005 Boehringer Ingelheim Investigational Site | Targu-Mures, Romania |
| 1245.9.70001 Boehringer Ingelheim Investigational Site | Ekaterinburg, Russian Federation |
| 1245.9.70002 Boehringer Ingelheim Investigational Site | Kazan, Russian Federation |
| 1245.9.70003 Boehringer Ingelheim Investigational Site | Nizhniy Novgorod, Russian Federation |
| 1245.9.70004 Boehringer Ingelheim Investigational Site | Petrozavodsk, Russian Federation |
| 1245.9.70005 Boehringer Ingelheim Investigational Site | Smolensk, Russian Federation |
| 1245.9.70006 Boehringer Ingelheim Investigational Site | Yaroslavl, Russian Federation |
| 1245.9.70007 Boehringer Ingelheim Investigational Site | Yaroslavl, Russian Federation |
| 1245.9.62002 Boehringer Ingelheim Investigational Site | Bratislava, Slovakia |
| 1245.9.62003 Boehringer Ingelheim Investigational Site | Lucenec, Slovakia |
| 1245.9.62004 Boehringer Ingelheim Investigational Site | Nove Mesto Nad Vahom, Slovakia |
| 1245.9.62001 Boehringer Ingelheim Investigational Site | Prievidza, Slovakia |
| 1245.9.46003 Boehringer Ingelheim Investigational Site | Göteborg, Sweden |
| 1245.9.46004 Boehringer Ingelheim Investigational Site | Härnösand, Sweden |
| 1245.9.46005 Boehringer Ingelheim Investigational Site | Lund, Sweden |
| 1245.9.46001 Boehringer Ingelheim Investigational Site | Stockholm, Sweden |
| 1245.9.46002 Boehringer Ingelheim Investigational Site | Västerås, Sweden |
| 1245.9.88605 Boehringer Ingelheim Investigational Site | Changhua, Taiwan |
| 1245.9.88607 Boehringer Ingelheim Investigational Site | Kaohsiung, Taiwan |
| 1245.9.88604 Boehringer Ingelheim Investigational Site | Taichung, Taiwan |
| 1245.9.88606 Boehringer Ingelheim Investigational Site | Tainan, Taiwan |
| 1245.9.88601 Boehringer Ingelheim Investigational Site | Taipei, Taiwan |
| 1245.9.88603 Boehringer Ingelheim Investigational Site | Taipei, Taiwan |
| 1245.9.88602 Boehringer Ingelheim Investigational Site | Taoyuan, Taiwan |
| 1245.9.38003 Boehringer Ingelheim Investigational Site | Kharkov, Ukraine |
| 1245.9.38004 Boehringer Ingelheim Investigational Site | Kiev, Ukraine |
| 1245.9.38002 Boehringer Ingelheim Investigational Site | Odessa, Ukraine |
| 1245.9.38005 Boehringer Ingelheim Investigational Site | Vinnytsya, Ukraine |
| 1245.9.38001 Boehringer Ingelheim Investigational Site | Vinnytsya, Ukraine |