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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 3, 2008
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S

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 ]
  • HbA1C [ Time Frame: After 10-20 weeks ]

Secondary Outcome Measures:
  • safety [ Time Frame: After 10-20 weeks ]
  • posology [ Time Frame: After 10-20 weeks ]
  • lifestyle [ Time Frame: After 10-20 weeks ]
  • FBG [ Time Frame: After 10-20 weeks ]

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®


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetic patients having failed on metformin monotherapy

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709917

Brussels, Belgium, 1070
Luxembourg, Luxembourg
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00709917     History of Changes
Other Study ID Numbers: AGEE-1857
First Submitted: June 30, 2008
First Posted: July 3, 2008
Last Update Posted: March 3, 2016
Last Verified: March 2016

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