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: June 13, 2014
Last verified: June 2014
  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: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00709917     History of Changes
Other Study ID Numbers: AGEE-1857
Study First Received: June 30, 2008
Last Updated: June 13, 2014
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 August 27, 2014