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Switch From Metformin Monotherapy to a Bitherapy With Metformin and Repaglinide (REPAMET 2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00745433
First Posted: September 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
  Purpose
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

Condition Intervention
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide Drug: metformin

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: REPAMET 2: Observational Study of the Switch From Metformin Monotherapy to Bitherapy With Metformin and Repaglinide

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: After 12-20 weeks. ]

Secondary Outcome Measures:
  • PPG [ Time Frame: After 12-20 weeks. ]
  • Number of hypoglycemic events [ Time Frame: After 12-20 weeks. ]
  • Variability in FPG (Fasting Plasma Glucose) [ Time Frame: After 12-20 weeks. ]

Enrollment: 906
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Repaglinide add-on to metformin.
Drug: repaglinide
Start dose and frequency at the discretion of the physician following clinical practice
Other Name: NovoNorm®
Drug: metformin
Start dose and frequency at the discretion of the physician following clinical practice

  Eligibility

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
Any subject with type 2 diabetes treated with metformin
Criteria

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)
  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): NCT00745433


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00745433     History of Changes
Other Study ID Numbers: AGEE-3558
First Submitted: September 1, 2008
First Posted: September 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
Repaglinide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs