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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00745433
First received: September 1, 2008
Last updated: March 2, 2016
Last verified: March 2016
  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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PPG [ Time Frame: After 12-20 weeks. ] [ Designated as safety issue: No ]
  • Number of hypoglycemic events [ Time Frame: After 12-20 weeks. ] [ Designated as safety issue: Yes ]
  • Variability in FPG (Fasting Plasma Glucose) [ Time Frame: After 12-20 weeks. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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: 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 
Study First Received: September 1, 2008
Last Updated: March 2, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

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

ClinicalTrials.gov processed this record on August 25, 2016