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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: metformin; Drug: repaglinide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01465152

AGEE-1411

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 3 patient groups

Met

Experimental group

Treatment:

Drug: metformin

Rep

Active Comparator group

Treatment:

Drug: repaglinide

Met+Rep

Active Comparator group

Treatment:

Drug: repaglinide

Drug: metformin