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

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.
 
ClinicalTrials.gov Identifier: NCT00745433
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide Drug: metformin

Study Design
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Study Type : Observational
Actual Enrollment : 906 participants
Time Perspective: Prospective
Official Title: REPAMET 2: Observational Study of the Switch From Metformin Monotherapy to Bitherapy With Metformin and Repaglinide
Study Start Date : January 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

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Groups and Cohorts
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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 Name: NovoNorm®

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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Belgium
Brussels, Belgium, 1070
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00745433    
Other Study ID Numbers: AGEE-3558
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Repaglinide
Hypoglycemic Agents
Physiological Effects of Drugs