Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes

Phase 4

Completed

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

• Registration Number: NCT01720290
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07-25
• Primary Completion: 2003-02-25
• Study Completion: 2003-02-25
• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (glycosylated haemoglobin A1c)

Secondary Outcome Measures

Name	Time	Method
Incidence of hypoglycemic episodes
1-hour post prandial blood glucose (PPBG)
Fasting blood glucose (FBG)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Shanghai, China