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
  Purpose

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.


Condition Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: repaglinide

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2171
Study Start Date: February 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: repaglinide
Start dose and freqency to be prescribed by the physician at his discretion following clinical practice
Other Names:
  • AGEE
  • Prandin®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Type 2 diabetic patients having failed on metformin monotherapy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00709917

Locations
Belgium
Brussels, Belgium, 1070
Luxembourg
Luxembourg, Luxembourg
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Steven De Beukelaer, MD sa Novo Nordisk Pharma
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00709917     History of Changes
Other Study ID Numbers: AGEE-1857
Study First Received: June 30, 2008
Last Updated: May 29, 2012
Health Authority: Belgium: Not required for observational study in Belgium
Luxembourg: Not required for observational study

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014