Observational Study of the Switch of Metformin Alone to Metformin Combined With Repaglinide in Type 2 Diabetes

Completed

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

• Registration Number: NCT00709917
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe.

The aim of this observational study is to investigate the switch from metformin alone to metformin combined with repaglinide in type 2 diabetic patients not achieving adequate glycaemic control on maximal dose of metformin given alone and to analyse different epidemiological parameters.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-06-30
• Study First Submitted QC: 2008-06-30
• Study First Posted: 2008-07-03
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2171

Inclusion Criteria

• Type 2 diabetic patients with inadequate glycaemic control when received metformin alone on maximal dose
• Signed informed consent
• Treatment in accordance with the summary of product characterisation

Exclusion Criteria

• Any contraindication to metformin or repaglinide

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	repaglinide	-

Primary Outcome Measures

Name	Time	Method
Safety (number of hypoglycaemic incidents)	After 10-20 weeks
HbA1C	After 10-20 weeks

Secondary Outcome Measures

Name	Time	Method
safety	After 10-20 weeks
posology	After 10-20 weeks
lifestyle	After 10-20 weeks
FBG	After 10-20 weeks