Comparison of Repaglinide and Metformin Administered Alone or in Combination in 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

NCT01720290

AGEE-3018

Details and patient eligibility

About

This trial is conducted in Asia. The aim of this trial is to compare repaglinide and metformin administered alone or in combination in subjects with type 2 diabetes.

Enrollment: 150 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously treated with oral hypoglycaemic agents (OHA) as monotherapy (if metformin, less than 1500 mg daily)
• Body Mass Index (BMI) of 21-35 kg/m^2
• HbA1c (glycosylated haemoglobin A1c) between 7.0-10%

Exclusion criteria

• Treatment with insulin within the last 3 months preceding the trial
• Uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg, and/or diastolic blood pressure above 105 mm Hg)
• Participation in any other clinical trial within 30 days of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Rep

Experimental group

Treatment:

Drug: repaglinide

Met

Active Comparator group

Treatment:

Drug: metformin

Drug: metformin

Rep + met

Active Comparator group

Treatment:

Drug: repaglinide

Drug: metformin

Drug: metformin