Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes |
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Condition | Diabetes Diabetes Mellitus, Type 2 |
Intervention | Drug: repaglinide Drug: metformin Drug: glicazide |
Phase | Phase 4 |
Sponsor | Novo Nordisk A/S |
Responsible Party | Novo Nordisk A/S |
ClinicalTrials.gov Identifier | NCT00568984 |
First Received | December 4, 2007 |
Last Updated | June 5, 2012 |
Last verified | January 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | December 4, 2007 |
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Last Updated Date | June 5, 2012 |
Start Date | November 2002 |
Estimated Primary Completion Date | November 2003 |
Current Primary Outcome Measures | HbA1c [Time Frame: after 16 weeks of treatment] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes |
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Official Title | Efficacy and Safety of Repaglinide and Metformin Combined in Type 2 Diabetes Mellitus |
Brief Summary | This trial is conducted in Asia. The aim of this trial is to investigate the efficacy of blood glucose control with combination therapy of repaglinide and metformin compared to conventional treatment with a sulphonylurea or metformin in monotherapy in type 2 diabetes |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: repaglinide Drug: metformin Drug: glicazide |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 324 |
Estimated Completion Date | November 2003 |
Estimated Primary Completion Date | November 2003 |
Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes for at least 3 months - No previous treatment for diabetes - HbA1c between 7.0-12.0% - Body Mass Index (BMI) between 19.0-40.0 kg/m2 Exclusion Criteria: - Type 1 diabetes - Known unstable/untreated proliferative retinopathy - Uncontrolled treated/untreated hypertension - Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | China, Malaysia, Philippines, Thailand |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00568984 |
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Other Study ID Numbers | AGEE-3017 |
Has Data Monitoring Committee | No |
Information Provided By | Novo Nordisk A/S |
Study Sponsor | Novo Nordisk A/S |
Collaborators | Not Provided |
Investigators | Study Director: Jing Ping Yeo Novo Nordisk Asia Pacific Pte. |
Verification Date | January 2012 |
Locations[ + expand ][ + ]
China, Beijing | Beijing, Beijing, China, 100034 |
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Malaysia | Cheras, Malaysia, 56000 |
Philippines | Manila, Philippines, 1003 |
Thailand | Bangkok, Thailand, 10330 |