An Open, Multi-center, Randomized Study to Evaluate the Efficacy and Safety of Mitiglinide Versus Acarbose in Patients With Type 2 Diabetes Mellitus in China
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 6
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
研究概览
简要总结
Mitiglinide, a benzylsuccinic acid derivative, exerts selective action on the ATP-dependent K (KATP) channel of pancreatic β-cells and reportedly possesses a stronger affinity to the channel compared with other insulinotropic sulphonylurea receptor ligands, namely repaglinide and nateglinide. Preprandial administration of mitiglinide efficiently reduces postprandial hyperglycemia and improves overall glycemic control.
This was a 12-week, open, randomized study for comparing Mitiglinide versus Acarbose. The purpose of this study is to evaluate the efficacy and safety of Mitiglinide vs Acarbose in patients with type 2 diabetes mellitus.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Mitiglinide
Mitiglinide 10 mg three times a day, orally, for 12 weeks
干预措施: Mitiglinide (Drug)
Acarbose
Acarbose 50 mg three times a day, orally, for 12 weeks
干预措施: Acarbose (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
时间窗: Baseline and Week 12
次要结局
- the change from baseline to the end of treatment in fasting blood glucose (FBG), postprandial blood glucose (PBG)(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Number of Participants with Serious and Non-Serious Adverse Events(up to 12 weeks)
- the change from baseline to the end of treatment in Diabetes Quality of Life(baseline and 12 weeks)
- Treatment compliance(up to 12 weeks)
- Diabetes Treatment Satisfaction(12 weeks)
研究者
Zilin Sun
Chief of Department of Endocrinology, Zhongda Hospital, Institute of Diabetes
Zhongda Hospital