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OpenTrials
Completed

NCT Number: NCT00745433

Switch From Metformin Monotherapy to a 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

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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, 1070, Belgium

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

repaglinide

Drug

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

Other names: NovoNorm®

metformin

Drug

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

Primary outcomes

  1. HbA1c

    Time frame: After 12-20 weeks.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

REPAMET 2: Observational Study of the Switch From Metformin Monotherapy to Bitherapy With Metformin and Repaglinide

Acronym: REPAMET 2

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 3, 2008
Registry last updated
Nov 2, 2023

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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