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Completed

NCT Number: NCT01465152

Comparison of Metformin, Repaglinide or the Combination of Both in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the efficacy of metformin and repaglinide used alone or combined administered as initial treatment in subjects with type 2 diabetes in which diet and exercise have failed.

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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

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with type 2 diabetes
  • Treated by diet for at least 3 months
  • Never treated with hypoglycaemic drugs
  • HbA1c (glycaemic haemoglobin A1c) on inclusion time superior to 6.5%

Exclusion criteria

  • Very symptomatic diabetes
  • Advanced vascular complications
  • Manifest renal failure
  • Manifest hepatic disease
  • Pregnancy, breast feeding or intention to become pregnant or if it is considered that the patient is not using adequate contraceptive measures. Adequate contraceptive measures are considered to be an intrauterine device, oral contraceptives and barrier methods

Treatment and study plan

metformin

Drug

Adminstered orally during the three main meals for 24 weeks

repaglinide

Drug

Administered orally before the three main meals for 24 weeks

Primary outcomes

  1. Change of % HbA1c (glycosylated haemoglobin) in blood

Secondary outcomes

  1. Change of the mean body mass index calculated as weight in kilograms divided by the square of height in metres

  2. Incidence of clinical and/or biochemistry hypoglycaemia episodes

  3. Incidence of adverse events

  4. Presence of laboratory abnormalities in routine blood analyses

  5. Change of the blood pressure and/or heart rate

  6. Treatment compliance

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Multicentre, Randomised, Comparative, Open, Three Armed Parallel Group Study on the Use of Metformin, Repaglinide or the Combination of Both in Type 2 Diabetic Patients After Failure of Dietary Measures

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Nov 4, 2011
Registry last updated
Feb 20, 2017

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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