Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: gliclazide; Drug: repaglinide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01022762

U1111-1111-9453 (Other Identifier)

AGEE-3783

Details and patient eligibility

About

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood glucose lowering effect and the safety profile of repaglinide given alone compared to gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated with oral anti-diabetic drugs (OADs). This study also investigates the augment effect of repaglinide on the phases of insulin secretion as a subgroup study.

Enrollment: 440 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this trial is allowed)
• Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
• Lipid-lowing agent naïve
• HbA1c: 6.5-8.5%
• Fasting glucose: 6.1-13.0 mmol/L (110-234 mg/dl)
• Body Mass Index (BMI): 20-35 kg/m^2
• Be able and willing to perform self-monitored plasma glucose (SMPG)
• Be able and willing to eat 3 main meals per day
• Only applicable to subjects who will participate in the subgroup study: Be able and willing to perform and complete IVGTT (intravenous glucose tolerance test) at additional visits

Exclusion criteria

• Known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (SUs)), or any of the excipients in the study drugs
• Previous participation in this study
• Participation in a study of another investigational drug within 1 month prior to study start

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

440 participants in 2 patient groups

repaglinide

Active Comparator group

Description:

1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily

Treatment:

Drug: repaglinide

gliclazide

Active Comparator group

Description:

80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily

Treatment:

Drug: gliclazide