Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
Purpose | This trial is conducted in Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed. |
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Condition | Diabetes Diabetes Mellitus, Type 2 |
Intervention | Drug: metformin Drug: repaglinide |
Phase | Phase 4 |
Sponsor | Novo Nordisk A/S |
Responsible Party | Novo Nordisk A/S |
ClinicalTrials.gov Identifier | NCT01465152 |
First Received | October 31, 2011 |
Last Updated | November 3, 2011 |
Last verified | November 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | October 31, 2011 |
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Last Updated Date | November 3, 2011 |
Start Date | March 2002 |
Estimated Primary Completion Date | October 2004 |
Current Primary Outcome Measures | Change of % HbA1c (glycosylated haemoglobin) in blood [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes |
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Official Title | Multicentre, Randomised, Comparative, Open, Three Armed Parallel Group Study on the Use of Metformin, Repaglinide or the Combination of Both in Type 2 Diabetic Patients After Failure of Dietary Measures |
Brief Summary | This trial is conducted in Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed. |
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: metformin Adminstered orally during the three main meals for 24 weeks Drug: repaglinide Administered orally before the three main meals for 24 weeks |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 182 |
Estimated Completion Date | October 2004 |
Estimated Primary Completion Date | October 2004 |
Eligibility Criteria | Inclusion Criteria: - Subjects with type 2 diabetes - Treated by diet for at least 3 months - Never treated with hypoglycaemic drugs - HbA1c (glycaemic haemoglobin A1c) on inclusion time superior to 6.5% Exclusion Criteria: - Very symptomatic diabetes - Advanced vascular complications - Manifest renal failure - Manifest hepatic disease - Pregnancy, breast feeding or intention to become pregnant or if it is considered that the patient is not using adequate contraceptive measures. Adequate contraceptive measures are considered to be an intrauterine device, oral contraceptives and barrier methods |
Gender | Both |
Ages | 35 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Spain |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01465152 |
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Other Study ID Numbers | AGEE-1411 |
Has Data Monitoring Committee | No |
Information Provided By | Novo Nordisk A/S |
Study Sponsor | Novo Nordisk A/S |
Collaborators | Not Provided |
Investigators | Study Director: Mónica Parramón Ponz Novo Nordisk Pharma SA |
Verification Date | November 2011 |
Locations[ + expand ][ + ]
Spain | Zaragoza, Spain, 50007 |
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