Switch From Metformin Monotherapy to a Bitherapy With Metformin and Repaglinide

Completed

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

• Registration Number: NCT00745433
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of this observational study is to investigate the efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical practice

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-09-01
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 906

Inclusion Criteria

• Type 2 diabetes
• Metformin monotreatment
• HbA1c greater than 7%
• Treatment according to SPC
• Informed consent obtained

Exclusion Criteria

• Any contraindication to the use of repaglinide (according to the SPC)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	metformin	Repaglinide add-on to metformin.
A	repaglinide	Repaglinide add-on to metformin.

Primary Outcome Measures

Name	Time	Method
HbA1c	After 12-20 weeks.

Secondary Outcome Measures

Name	Time	Method
PPG	After 12-20 weeks.
Number of hypoglycemic events	After 12-20 weeks.
Variability in FPG (Fasting Plasma Glucose)	After 12-20 weeks.