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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01465152

Enrollment

182

Registered

2011-11-04

Start date

2002-03-06

Completion date

2004-10-21

Last updated

2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGmetformin

Adminstered orally during the three main meals for 24 weeks

DRUGrepaglinide

Administered orally before the three main meals for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change of % HbA1c (glycosylated haemoglobin) in blood	—

Secondary

Measure	Time frame
Incidence of clinical and/or biochemistry hypoglycaemia episodes	—
Incidence of adverse events	—
Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres	—
Change of the blood pressure and/or heart rate	—
Treatment compliance	—
Presence of laboratory abnormalities in routine blood analyses	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026