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

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: metformin; Drug: repaglinide

• Registration Number: NCT01465152
• Lead Sponsor: Novo Nordisk A/S

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 available

Study Timeline

• Study Start: 2002-03-06
• Primary Completion: 2004-10-21
• Study Completion: 2004-10-21
• Study First Submitted: 2011-10-31
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Met+Rep	metformin	-
Rep	repaglinide	-
Met	metformin	-
Met+Rep	repaglinide	-

Primary Outcome Measures

Name	Time	Method
Change of % HbA1c (glycosylated haemoglobin) in blood

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇪🇸 Zaragoza, Spain