Switch From Metformin Monotherapy to a Bitherapy With Metformin and Repaglinide

Verified by: Novo Nordisk, October 2010
First Received: September 1, 2008 | Last Updated: October 8, 2010 | Phase: N/A | Start Date: January 2008
Overall Status: Completed | Estimated Enrollment: 906
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This study is conducted in Europe. The aim of this observational study is to investigate the efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical...

Brief Summary

Official Title: “REPAMET 2: Observational Study of the Switch From Metformin Monotherapy to Bitherapy With Metformin and Repaglinide”

This study is conducted in Europe. The aim of this observational study is to investigate the efficacy (e.g. glycemic control) and safety (e.g. hypoglycemic episodes) when adding repaglinide to a monotherapy of metformin in type 2 diabetic patients under normal clinical practice

  • Study Type: Observational
  • Study Design: Time Perspective: Prospective
  • Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

  • Drug: repaglinide
    • Start dose and frequency at the discretion of the physician following clinical practice
  • Drug: metformin
    • Start dose and frequency at the discretion of the physician following clinical practice

Arms, Groups and Cohorts in this Clinical Trial

  • : A
    • Repaglinide add-on to metformin.

Outcome Measures for this Clinical Trial

Primary Measures

  • HbA1c
    • Time Frame: After 12-20 weeks.
      Safety Issue?: No

Secondary Measures

  • PPG
    • Time Frame: After 12-20 weeks.
      Safety Issue?: No
  • Number of hypoglycemic events
    • Time Frame: After 12-20 weeks.
      Safety Issue?: Yes
  • Variability in FPG (Fasting Plasma Glucose)
    • Time Frame: After 12-20 weeks.
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Type 2 diabetes
  • Metformin monotreatment
  • HbA1c greater than 7%
  • Treatment according to SPC
  • Informed consent obtained

Exclusion Criteria:

  • Any contraindication to the use of repaglinide (according to the SPC)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Novo Nordisk Industry

Overall Clinical Trial Officials and Contacts

Dirk D'Hooge Study Director sa Novo Nordisk Pharma  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00745433

Study ID Number: AGEE-3558

ClinicalTrials.gov Identifier: NCT00745433

Health Authority: Belgium: Federal Agency for Medicines and Health Products

Clinical Trials at Novo Nordisk

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00745433