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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00709917
First received: June 30, 2008
Last updated: May 29, 2012
Last verified: May 2012

June 30, 2008
May 29, 2012
February 2007
January 2008   (final data collection date for primary outcome measure)
  • Safety (number of hypoglycaemic incidents) [ Time Frame: After 10-20 weeks ] [ Designated as safety issue: No ]
  • HbA1C [ Time Frame: After 10-20 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00709917 on ClinicalTrials.gov Archive Site
  • safety [ Time Frame: After 10-20 weeks ] [ Designated as safety issue: Yes ]
  • posology [ Time Frame: After 10-20 weeks ] [ Designated as safety issue: No ]
  • lifestyle [ Time Frame: After 10-20 weeks ] [ Designated as safety issue: No ]
  • FBG [ Time Frame: After 10-20 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Observational Study of the Switch of Metformin Alone to Metformin Combined With Repaglinide in Type 2 Diabetes
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

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Type 2 diabetic patients having failed on metformin monotherapy

  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: repaglinide
Start dose and freqency to be prescribed by the physician at his discretion following clinical practice
Other Names:
  • AGEE
  • Prandin®
A
Intervention: Drug: repaglinide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2171
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Luxembourg
 
NCT00709917
AGEE-1857
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Steven De Beukelaer, MD sa Novo Nordisk Pharma
Novo Nordisk A/S
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP