A 12-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Equa (Vildagliptin) 50 mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups
研究概览
简要总结
The purpose of this study was to assess the efficacy and safety of vildagliptin 50 mg bid add-on therapy to improve overall glycemic control in patients with T2DM inadequately controlled by insulin, with or without concomitant metformin treatment. It was agreed with PMDA to conduct a postmarketing clinical trial to further collect the efficacy and safety data of vildagliptin especially in Japanese patients when it iwas used on top of insulin.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of T2DM by standard criteria.
- •HbA1c ≥ 7.0 to ≤ 10% at Visit
- •Age: ≥ 20 to < 75 years old at Visit
- •BMI ≥ 20 to ≤ 35 kg/m2 at Visit 1.
排除标准
- •FPG ≥ 270 mg/dL (≥15 mmol/L) at Visit
- •Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
- •Significant heart diseases
- •Hepatic disorder
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Vildagliptin (LAF237)
Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
干预措施: Vildagliptin (LAF237) (Drug)
Vildagliptin (LAF237)
Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
干预措施: Insulin (Drug)
Vildagliptin (LAF237)
Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
干预措施: Metformin (Drug)
Placebo
In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
干预措施: Placebo (Drug)
Placebo
In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
干预措施: Insulin (Drug)
Placebo
In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
干预措施: Metformin (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups
时间窗: Baseline, week 12
HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory.
次要结局
- Percentage of Patients Meeting Responder Rates in HbA1c(Baseline, week 12)
- Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia(12 weeks)
- Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks(Baseline, week 12)
- Number of Participants With Adverse Events, Serious Adverse Events and Death(12 weeks)