Comparison of the Blood Sugar Lowering Effect Between Repaglinide Plus Metformin and Repaglinide Alone in Type 2 Diabetics Not Previously Treated With Oral Sugar-lowering Drugs

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: repaglinide; Drug: metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00819741

AGEE-3705

Details and patient eligibility

About

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of repaglinide plus metformin as initial treatment compared to repaglinide alone in Chinese subjects with type 2 diabetes having an HbA1c (glycosylated haemoglobin A1c) over 8.5 % and who never have taken oral sugar-lowering drugs before. The associated unfavourable events including low blood sugar episodes between the two treatments are also compared.

Enrollment: 433 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with type 2 diabetes
• Never taken oral antidiabetic drugs before
• HbA1c greater than 8.5 %
• BMI (Body Mass Index) less than or equal to 35 kg/m^2

Exclusion criteria

• Known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications
• Taken an investigational drug in another clinical trial within 4 weeks prior to this trial
• Impaired liver function, defined as ASAT (aspartate aminotransferase) or ALAT (alanine aminotransferase) equal to or greater than 2 times upper normal limit
• Have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems
• Severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (BP) equal to or greater than 100 mmHg or systolic BP equal to or greater than 180 mmHg)
• Impaired renal function
• Acute or chronic acidosis or if there are plans to have a radiographic material containing iodine
• Have a clinically significant, active cardiovascular disease, or decompensated heart failure
• Treatment with systemic corticosteroids within the past two months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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433 participants in 2 patient groups

Repaglinide + metformin

Experimental group

Description:

Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.

Treatment:

Drug: repaglinide

Drug: metformin

Drug: repaglinide

Repaglinide

Active Comparator group

Description:

Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.

Treatment:

Drug: repaglinide

Drug: repaglinide