Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes

Novo Nordisk A/S182 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

182

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

metforminDRUG

Adminstered orally during the three main meals for 24 weeks

repaglinideDRUG

Administered orally before the three main meals for 24 weeks

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (18)

Novo Nordisk Investigational Site

Barcelona, Spain

Novo Nordisk Investigational Site

Benamargosa, Spain

Outcomes

Primary Outcomes

Change of % HbA1c (glycosylated haemoglobin) in blood

Secondary Outcomes

Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres

Incidence of clinical and/or biochemistry hypoglycaemia episodes

Incidence of adverse events

Presence of laboratory abnormalities in routine blood analyses

Change of the blood pressure and/or heart rate

Treatment compliance

Data from ClinicalTrials.gov

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