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Completed

NCT Number: NCT01698931

Efficacy of Repaglinide in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the efficacy of repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2 diabetes.

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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

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site

Padova, 35137, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • HbA1c (glycosylated haemoglobin A1c) above 7 %
  • BMI (body mass index) below 32 kg/m^2
  • FBG (fasting blood glucose) after wash out period 130-220 mg/dl
  • Currently treated with diet or OHA (oral hypoglycaemic agent)

Exclusion criteria

  • Current systemic treatment with concomitant medication
  • Known or suspected history of drug or alcohol dependence
  • Any other significant concomitant disease such as cerebrovascular or symptomatic peripheral vascular disease, malignant, disease or severe treated or untreated hypertension
  • Hepatic disease
  • Cardiac problems
  • Active proliferative retinopathy
  • Known or suspected allergy to trial product or related products
  • Women in fertile age and women having the intention of becoming pregnant
  • Body Mass Index (BMI) above 32 kg/m^2

Treatment and study plan

repaglinide

Drug

1 mg before each main meal on three separate dosing visits separated by a wash-out period

Glyburide

Drug

5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period

Placebo

Drug

Before each main meal on three separate dosing visits separated by a wash-out period

Primary outcomes

  1. Basal hepatic glucose production

    Time frame: Day 0; day 44

Secondary outcomes

  1. Number of hypoglycaemic episodes

    Time frame: Day 0; day 44

  2. Change in body weight

    Time frame: Day 0; day 44

  3. Number of adverse events

    Time frame: Day 0; day 44

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy of Repaglinide Compared to Glyburide and Placebo on Hepatic Glucose Metabolism in Type 2 Diabetic Subjects Treated With Diet or With Antidiabetic Oral Agents. A Randomized, Open, Cross-over Single-centre Placebo-controlled Trial

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Oct 3, 2012
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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