A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals. |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: DPP-IV Inhibitor Drug: Placebo Drug: Metformin |
Phase | Phase 2 |
Sponsor | Hoffmann-La Roche |
Responsible Party | Hoffmann-La Roche |
ClinicalTrials.gov Identifier | NCT00111631 |
First Received | May 24, 2005 |
Last Updated | April 7, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | May 24, 2005 |
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Last Updated Date | April 7, 2014 |
Start Date | May 2005 |
Estimated Primary Completion Date | October 2006 |
Current Primary Outcome Measures | Absolute change from baseline in HbAlc\n [Time Frame: Week 16] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes |
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Official Title | A Randomized, Double-blind Study of the Effect of the DPP-IV Inhibitor on HbA1c and Safety in Patients With Type 2 Diabetes Treated With a Stable Dose of Metformin |
Brief Summary | This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 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: DPP-IV Inhibitor Escalating doses po bid Drug: Placebo po bid Drug: Metformin As prescribed |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 218 |
Estimated Completion Date | October 2006 |
Estimated Primary Completion Date | October 2006 |
Eligibility Criteria | Inclusion Criteria: - adult patients 18-75 years of age; - type 2 diabetes; - stable metformin therapy for >=3 months before screening. Exclusion Criteria: - women who are pregnant, breast-feeding, or not using an adequate contraceptive method; - type 1 diabetes; - any anti-hyperglycemic medication other than metformin in the last 3 months. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Australia, Canada, Germany, Italy |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00111631 |
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Other Study ID Numbers | BM18106 |
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, California | Concord, California, United States, 94520 |
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United States, California | Salinas, California, United States, 93901 |
United States, California | San Diego, California, United States, 92161 |
United States, Colorado | Boulder, Colorado, United States, 80304 |
United States, Delaware | Newark, Delaware, United States, 19713 |
United States, Delaware | Wilmington, Delaware, United States, 19085 |
United States, Florida | Clearwater, Florida, United States, 33765 |
United States, Florida | Miami, Florida, United States, 33156 |
United States, Illinois | Chicago, Illinois, United States, 60607 |
United States, Michigan | Detroit, Michigan, United States, 48202-2689 |
United States, New York | Buffalo, New York, United States, 14209 |
United States, New York | Rochester, New York, United States, 14609 |
United States, North Carolina | Durham, North Carolina, United States, 27713 |
United States, Ohio | Mogadore, Ohio, United States, 44260 |
United States, Oregon | Portland, Oregon, United States, 97239 |
United States, Pennsylvania | Connellsville, Pennsylvania, United States, 15425 |
United States, Pennsylvania | Warminster, Pennsylvania, United States, 18974 |
United States, Texas | Dallas, Texas, United States, 75246 |
United States, Texas | Midland, Texas, United States, 79707 |
United States, Texas | San Antonio, Texas, United States, 78229 |
Australia | Adelaide, Australia, 5000 |
Australia | Sydney, Australia, 2050 |
Canada, Manitoba | Winnipeg, Manitoba, Canada, R3E 3P4 |
Canada, Nova Scotia | Halifax, Nova Scotia, Canada, B3H 1V7 |
Canada, Ontario | London, Ontario, Canada, NGA 4V2 |
Canada, Ontario | Toronto, Ontario, Canada, M5C 2T2 |
Germany | Bad Lauterberg, Germany, 37431 |
Germany | Berlin, Germany, 10115 |
Germany | Dresden, Germany, 01307 |
Germany | Görlitz, Germany, 02826 |
Germany | Mainz, Germany, 55116 |
Germany | Neuss, Germany, 41460 |
Italy | Ancona, Italy, 60131 |
Italy | Firenze, Italy, 50100 |
Italy | Napoli, Italy, 80100 |
Italy | Udine, Italy, 33100 |
Puerto Rico | Ponce, Puerto Rico, 00716 |