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Observational Study of the Switch of Metformin Alone to Metformin Combined With Repaglinide in Type 2 Diabetes (REPAMET)

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ClinicalTrials.gov Identifier: NCT00709917
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This study is conducted in Europe.

The aim of this observational study is to investigate the switch from metformin alone to metformin combined with repaglinide in type 2 diabetic patients not achieving adequate glycaemic control on maximal dose of metformin given alone and to analyse different epidemiological parameters.


Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide

Study Type : Observational
Actual Enrollment : 2171 participants
Time Perspective: Prospective
Official Title: Observational Study Investigating the Efficacy of Switching From Metformin Monotherapy to a Dual Therapy of Metformin and Repaglinide on Glycaemic Control in Type 2 Diabetes
Study Start Date : March 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
A Drug: repaglinide
Start dose and freqency to be prescribed by the physician at his discretion following clinical practice
Other Names:
  • AGEE
  • Prandin®



Primary Outcome Measures :
  1. Safety (number of hypoglycaemic incidents) [ Time Frame: After 10-20 weeks ]
  2. HbA1C [ Time Frame: After 10-20 weeks ]

Secondary Outcome Measures :
  1. safety [ Time Frame: After 10-20 weeks ]
  2. posology [ Time Frame: After 10-20 weeks ]
  3. lifestyle [ Time Frame: After 10-20 weeks ]
  4. FBG [ Time Frame: After 10-20 weeks ]


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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
Type 2 diabetic patients having failed on metformin monotherapy
Criteria

Inclusion Criteria:

  • Type 2 diabetic patients with inadequate glycaemic control when received metformin alone on maximal dose
  • Signed informed consent
  • Treatment in accordance with the summary of product characterisation

Exclusion Criteria:

  • Any contraindication to metformin or repaglinide

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): NCT00709917


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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00709917     History of Changes
Other Study ID Numbers: AGEE-1857
First Posted: July 3, 2008    Key Record Dates
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