Efficacy of Repaglinide in Subjects With Type 2 Diabetes

Novo Nordisk A/S9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

repaglinideDRUG

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

glyburideDRUG

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

placeboDRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Padua, Italy

Outcomes

Primary Outcomes

Basal hepatic glucose production

Time frame: Day 0; day 44

Secondary Outcomes

Number of hypoglycaemic episodes

Time frame: Day 0; day 44

Change in body weight

Time frame: Day 0; day 44

Number of adverse events

Time frame: Day 0; day 44

Data from ClinicalTrials.gov

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