Efficacy of Repaglinide in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698931
• Other study ID #: AGEE-1259
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2012
• Last updated: February 17, 2017
• Start date: April 26, 2002
• Est. completion date: March 6, 2003

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 6, 2003
• Est. primary completion date: March 6, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• repaglinide
1 mg before each main meal on three separate dosing visits separated by a wash-out period
• glyburide
5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period
• placebo
Before each main meal on three separate dosing visits separated by a wash-out period

Locations

Country	Name	City	State
Italy	Novo Nordisk Investigational Site	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Ciccarone A, Mari A, Pulizzi N, Bianchi C, Palumbo F, Benzi L, Del Prato S. Assessment of insulin secretion in response to a mixed meal in type 2 diabetes. Effects of short-term repaglinide and glibenclamide administration. Diabetologia 2005; 48 (Suppl. 1

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basal hepatic glucose production		Day 0; day 44
Secondary	Number of hypoglycaemic episodes		Day 0; day 44
Secondary	Change in body weight		Day 0; day 44
Secondary	Number of adverse events		Day 0; day 44

External Links

•   Clinical Trials at Novo Nordisk