Completed

Repaglinide vs Glyburide and Placebo: Impact on Hepatic Glucose Metabolism in Type 2 Diabetes

Study Aim

This study aims to compare the effects of Repaglinide and Glyburide on hepatic glucose production in individuals with Type 2 Diabetes.

What is being tested

repaglinide

+ glyburide

+ placebo

Drug

Who is being recruted

Endocrine System Diseases+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 40 to 75 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 4

Interventional

Study Start: April 2002

See protocol details

Summary

Principal SponsorNovo Nordisk A/S

Last updated: February 20, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: April 26, 2002

Actual date on which the first participant was enrolled.

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.

NCT01698931

Principal SponsorNovo Nordisk A/S

Last updated: February 20, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

9 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes MellitusDiabetes Mellitus, Type 2

Criteria

5 inclusion criteria required to participate

BMI (body mass index) below 32 kg/m^2

Currently treated with diet or OHA (oral hypoglycaemic agent)

FBG (fasting blood glucose) after wash out period 130-220 mg/dl

HbA1c (glycosylated haemoglobin A1c) above 7 %

Show More Criteria

9 exclusion criteria prevent from participating

Active proliferative retinopathy

Any other significant concomitant disease such as cerebrovascular or symptomatic peripheral vascular disease, malignant, disease or severe treated or untreated hypertension

Body Mass Index (BMI) above 32 kg/m^2

Cardiac problems

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Group III

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Novo Nordisk Investigational Site

Padova, ItalyOpen Novo Nordisk Investigational Site in Google Maps

CompletedOne Study Center