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NCT00709917 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— REPAMET  

Official title:
Observational Study Investigating the Efficacy of Switching From Metformin Monotherapy to a Dual Therapy of Metformin and Repaglinide on Glycaemic Control in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00709917
Other study ID # AGEE-1857
Secondary ID
Status Completed
Phase N/A
First received June 30, 2008
Last updated March 2, 2016
Start date March 2007
Est. completion date January 2008

Study information
Verified date March 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Belgium: Not required for observational study in BelgiumLuxembourg: Not required for observational study
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2171
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• repaglinide
Start dose and freqency to be prescribed by the physician at his discretion following clinical practice

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Belgium,  Luxembourg, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety (number of hypoglycaemic incidents) After 10-20 weeks No
Primary HbA1C After 10-20 weeks No
Secondary safety After 10-20 weeks Yes
Secondary posology After 10-20 weeks No
Secondary lifestyle After 10-20 weeks No
Secondary FBG After 10-20 weeks No
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