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

October 31, 2023 updated by: Novo Nordisk A/S

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

906

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any subject with type 2 diabetes treated with metformin

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Repaglinide add-on to metformin.
Drug: repaglinide
Start dose and frequency at the discretion of the physician following clinical practice
Other Names:
  • NovoNorm®
Drug: metformin
Start dose and frequency at the discretion of the physician following clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: After 12-20 weeks.
After 12-20 weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
PPG
Time Frame: After 12-20 weeks.
After 12-20 weeks.
Number of hypoglycemic events
Time Frame: After 12-20 weeks.
After 12-20 weeks.
Variability in FPG (Fasting Plasma Glucose)
Time Frame: After 12-20 weeks.
After 12-20 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 1, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimated)

September 3, 2008

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGEE-3558

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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