Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGrepaglinide
1 mg before each main meal on three separate dosing visits separated by a wash-out period
DRUGglyburide
5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period
DRUGplacebo
Before each main meal on three separate dosing visits separated by a wash-out period
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Basal hepatic glucose production | Day 0; day 44 |
Secondary
| Measure | Time frame |
|---|---|
| Number of hypoglycaemic episodes | Day 0; day 44 |
| Change in body weight | Day 0; day 44 |
| Number of adverse events | Day 0; day 44 |
Countries
Italy
Outcome results
None listed