A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin
Overview[ - collapse ][ - ]
| Purpose | This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals. |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: GK Activator (2) Drug: Metformin |
| Phase | Phase 2 |
| Sponsor | Hoffmann-La Roche |
| Responsible Party | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier | NCT00266253 |
| First Received | December 15, 2005 |
| Last Updated | April 7, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 15, 2005 |
|---|---|
| Last Updated Date | April 7, 2014 |
| Start Date | November 2005 |
| Estimated Primary Completion Date | March 2007 |
| Current Primary Outcome Measures | HbA1c mean change from baseline compared with placebo. [Time Frame: Week 12] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin |
|---|---|
| Official Title | A Randomized Double-blind Study to Determine the Effect of GK Activator (2) on Efficacy (HbA1c), Safety, Tolerability and Pharmacokinetics in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin. |
| Brief Summary | This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of GK Activator (2) in combination with metformin, compared to that of placebo (metformin monotherapy), in patients with type 2 diabetes mellitus. Patients will continue on their stable dose of metformin and will be randomized to receive either GK Activator (2) or placebo. The anticipated time on study treatment is less than 3 months, and the target sample size is 100-500 individuals. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: GK Activator (2) Escalating doses, po bid or qd for 12 weeks. Drug: Metformin As prescribed, for 12 weeks |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 220 |
| Estimated Completion Date | March 2007 |
| Estimated Primary Completion Date | March 2007 |
| Eligibility Criteria | Inclusion Criteria: - adult patients 30-75 years of age; - type 2 diabetes mellitus; - individual maximal tolerated daily dose of metformin monotherapy for >=3 months prior to screening. Exclusion Criteria: - type 1 diabetes mellitus; - any oral anti-hyperglycemic medication, other than metformin monotherapy, during last 3 months |
| Gender | Both |
| Ages | 30 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Australia, Canada, Germany, Spain, United Kingdom |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00266253 |
|---|---|
| Other Study ID Numbers | BM18249 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Hoffmann-La Roche |
| Study Sponsor | Hoffmann-La Roche |
| Collaborators | Not Provided |
| Investigators | Study Director: Clinical Trials Hoffmann-La Roche |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| United States, Arizona | Phoenix, Arizona, United States, 85012 |
|---|---|
| United States, California | Chula Vista, California, United States, 91910 |
| United States, California | Los Angeles, California, United States, 90057 |
| United States, Florida | Kissimmee, Florida, United States, 34741 |
| United States, Florida | Tampa, Florida, United States, 33603 |
| United States, Georgia | Lawrenceville, Georgia, United States, 30045 |
| United States, Kansas | Arkansas City, Kansas, United States, 67005 |
| United States, Michigan | Benzonia, Michigan, United States, 49616 |
| United States, Missouri | Springfield, Missouri, United States, 65804 |
| United States, Montana | Butte, Montana, United States, 59701 |
| United States, Ohio | Kettering, Ohio, United States, 45429 |
| United States, Oklahoma | Tulsa, Oklahoma, United States, 74104 |
| United States, Oregon | Medford, Oregon, United States, 97504 |
| United States, Pennsylvania | Morrisville, Pennsylvania, United States, 19067 |
| United States, Pennsylvania | Philadelphia, Pennsylvania, United States, 19107 |
| United States, Tennessee | Memphis, Tennessee, United States, 38119 |
| United States, Washington | Bellevue, Washington, United States, 98004 |
| United States, Washington | Federal Way, Washington, United States, 98003 |
| Australia | Adelaide, Australia, 5000 |
| Australia | Heidelberg, Australia, 3081 |
| Australia | Sydney, Australia, 2050 |
| Canada, Alberta | Edmonton, Alberta, Canada, T5N 3Y6 |
| Canada, British Columbia | Vancouver, British Columbia, Canada, V5Z 1M9 |
| Canada, Ontario | London, Ontario, Canada, NGA 4V2 |
| Canada, Quebec | Montreal, Quebec, Canada, H1T 2M4 |
| Canada, Quebec | Sherbrooke, Quebec, Canada, J1H 4J6 |
| Germany | Bammental, Germany, 69245 |
| Germany | Berlin, Germany, 10115 |
| Germany | Essen, Germany, 45355 |
| Germany | Giessen, Germany, 35385 |
| Germany | Görlitz, Germany, 02826 |
| Germany | Hamburg, Germany, 20249 |
| Germany | Kuenzing, Germany, 94550 |
| Germany | Mannheim, Germany, 68161 |
| Germany | Nürnberg, Germany, 90402 |
| Germany | Tann, Germany, 36142 |
| Spain | Alzira, Spain, 46600 |
| Spain | Bacarot Alicant, Spain, 03114 |
| Spain | Baracaldo, Spain, 48903 |
| Spain | Barcelona, Spain, 08036 |
| United Kingdom | Dundee, United Kingdom, DD1 5LA |
| United Kingdom | Frome, United Kingdom, BA11 1EZ |
| United Kingdom | Glasgow, United Kingdom, G45 9AW |
| United Kingdom | Liverpool, United Kingdom, L9 7AL |
| United Kingdom | Motherwell, United Kingdom, ML1 3JX |
| United Kingdom | Northwood, United Kingdom, HA6 2RN |
| United Kingdom | Plymouth, United Kingdom, PL6 7TH |