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

A 16-week, Open-label, Multicentre, Randomised, Parallel Study to Evaluate Efficacy and Safety of Repaglinide and Metformin Combination Therapy Compared to Repaglinide Monotherapy in Chinese OAD Naive Type 2 Diabetic Patients

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.

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