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Metformin vs Repaglinide in Non-Obese T2DM

NCT00118950Phase 4

Key facts

Status: Completed
Start: Mar 2001
Countries: 1
Sponsor: Steno Diabetes Center Copenhagen
Modality: Small Molecules

Drugs: liquid metformin (Aspargo Labs)
Conditions: type 2 diabetes mellitus (T2DM)

Overview

Phase 4, randomised, double-blind trial of liquid metformin (Aspargo Labs) in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Steno Diabetes Center Copenhagen. Primary endpoint: Haemoglobin A1c at 4 months. Started Mar 2001; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Metformin First Sequence
Patients receive Metformin in Period 1, then Repaglinide in Period 2
Repaglinide First Sequence
Patients receive Repaglinide in Period 1, then Metformin in Period 2

Who it enrols

Non-obese (BMI <= 27) type 2 diabetic patients aged >= 40, uncontrolled by diet (HbA1c >= 6.5%), with preserved insulin secretion (C-peptide criteria) and no insulin treatment.

Endpoints

Primary

Haemoglobin A1c4 months

Secondary

Home-monitored 7-point plasma-glucose profiles4 months
Body-weight4 months
Waist-circumference4 months
Hip-circumference4 months
Lipoproteins and triglycerides4 months
Biomarkers related to inflammation4 months
Biomarkers related to endothelial dysfunction4 months
Albuminuria4 months

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