Efficacy and Safety of Mitiglinide vs Acarbose in Patients With Type 2 Diabetes Mellitus

Group I (Mitiglinide): Mitiglinide 10 mg three times a day, orally, for 12 weeks Group II (Acarbose): Acarbose 50 mg three times a day, orally, for 12 weeks Total subjects: 248, randomized to 2 groups at ratio of 1:1.

Inclusion criteria

• Subjects aged between 18 and 70, regardless of gender
• Subjects with type-2 diabetes mellitus diagnosed according to 1999 WHO criteria within 5 years
• Subjects who had not received insulin secretagogues, insulin sensitizers, incretin mimetics or alpha-glucosidase inhibitors
• Subjects whose fasting blood glucose [FBG] between7.0 and10.0 mmol/L and HbA1c ratio is between 7.0% and 10.0%

Note: Incretin mimetics contain glucagon-like peptide 1 (GLP-1) receptor agonist (including GLP-1 analogues) and dipeptidyl peptidase 4 inhibitors.

Exclusion criteria

• Subjects with abnormal hepatic function whose aspartate transaminase (AST) and alanine transaminase (ALT) are 2 times higher than the upper limits of normal (ULN)
• Subjects with renal disfunction whose plasma creatinine concentration are more than 1.1 ULN or positive urine protein
• Subjects with severe heart disease, liver diseases, kidney disease and other serious organic disease
• Subjects who have chronic intestinal diseases associated with marked disorders of digestion or absorption and may deteriorate as a result of increased gas formation in the intestine (like Gastrocardiac Syndrome, severe hernia, intestinal obstruction, intestinal ulcer and intestinal surgery)
• Subjects with endocrine system diseases such as hyperthyroidism and cushing's syndrome etc.
• Subject is contraindicated or hypersensitivity to both experimental drugs or comparator drugs
• Subjects who participated in other clinical studies as subjects within 3 months before this study
• Female subjects who have been pregnant , lactating or without contraception in childbearing potential
• Subjects judged unfit for this study by investigators