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Repaglinide vs Glyburide on Postprandial Lipemia in Type 2 Diabetes
NCT01605773Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2001
- Primary completion
- Mar 2003
- Countries
- 1
- Sponsor
- Novo Nordisk
- Modality
- Small Molecules
- Drugs
- repaglinide
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 4, randomised, open-label trial of repaglinide in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Novo Nordisk. Primary endpoint: Triglyceride levels post standardised fat tolerance test. Started Nov 2001; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
repaglinide
Repaglinide, dose individually adjusted
glyburide
Glyburide, dose individually adjusted
03
Who it enrols
Patients with type 2 diabetes, either newly diagnosed (diet/exercise only) or treated with sulphonylureas, with normal renal function and no uncontrolled hypertension.
04
Endpoints
Primary
Triglyceride levels post standardised fat tolerance test
Secondary
Incidence of hypoglycemic episodes
Change in HbA1c (glycosylated haemoglobin A1c)
Change in FPG (fasting plasma glucose)
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