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Completed

NCT Number: NCT00709917

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repaglinide

Drug

Start dose and freqency to be prescribed by the physician at his discretion following clinical practice

Other names: AGEE, Prandin®

Primary outcomes

  1. Safety (number of hypoglycaemic incidents)

    Time frame: After 10-20 weeks

  2. HbA1C

    Time frame: After 10-20 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: REPAMET

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 3, 2008
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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