Efficacy of Repaglinide in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: repaglinide; Drug: glyburide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01698931

AGEE-1259

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

9 participants in 3 patient groups, including a placebo group

Treatment period 1

Experimental group

Treatment:

Drug: placebo

Drug: repaglinide

Drug: glyburide

Treatment period 2

Active Comparator group

Treatment:

Drug: placebo

Drug: repaglinide

Drug: glyburide

Treatment period 3

Placebo Comparator group

Treatment:

Drug: placebo

Drug: repaglinide

Drug: glyburide