A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding Clinical Trial of MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 813
- 主要终点
- Change in Hemoglobin A1c (HbA1c) Level
研究概览
简要总结
The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy.
详细描述
This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK-0941-007-11). Beginning on Week 16, participants not randomized to the maximum dose of MK-0941 could up-titrate to MK-0941 40 mg three times daily. Participants who complete the 54-week base study are eligible to enter the extension study and will remain in the treatment group to which they were assigned in the base study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has type 2 diabetes mellitus
- •has body mass index >20 and <43 kg/m^2
- •is a male, or a female who is unlikely to conceive
- •currently on a stable dose of insulin with or without metformin for Type 2 diabetes mellitus
- •Extension Study Inclusion Criteria:
- •completed the base study either on double-blind study medication or as part of the post-treatment follow up population
- •had ≥85% compliance with double-blind and open-label medication during the base study double-blind treatment period
排除标准
- •has any history of Type 1 diabetes mellitus or ketoacidosis
- •has received more that 1 week of thiazolidinedione (such as pioglitazone or rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within the prior 8 weeks
- •has had ≥2 episodes during their lifetime or >1 episode within the past year resulting in hypoglycemic seizures, comas, or unconsciousness
- •is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1
- •has undergone surgery within 30 days prior to Visit 1 or has planned major surgery
研究组 & 干预措施
MK-0941 30 mg
干预措施: Lantus (Biological)
MK-0941 10 mg
干预措施: MK-0941 (Drug)
MK-0941 10 mg
干预措施: Lantus (Biological)
MK-0941 10 mg
干预措施: Metformin (Drug)
MK-0941 20 mg
干预措施: MK-0941 (Drug)
MK-0941 20 mg
干预措施: Lantus (Biological)
MK-0941 20 mg
干预措施: Metformin (Drug)
MK-0941 30 mg
干预措施: MK-0941 (Drug)
MK-0941 30 mg
干预措施: Metformin (Drug)
MK-0941 40 mg
干预措施: MK-0941 (Drug)
MK-0941 40 mg
干预措施: Lantus (Biological)
MK-0941 40 mg
干预措施: Metformin (Drug)
Placebo
干预措施: Lantus (Biological)
Placebo
干预措施: Metformin (Drug)
结局指标
主要结局
Change in Hemoglobin A1c (HbA1c) Level
时间窗: Baseline and Weeks 14, 54, 106, and 158
Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level.
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
时间窗: Entire study including 54-week study and 104-week extension
Percentage of Participants Who Experienced at Least One Adverse Event
时间窗: Entire study including 54-week study and 104-week extension
次要结局
- Change in the Two-hour Post Meal Glucose Level(Baseline and Weeks 14, 54, 106, and 158)
- Change in the Fasting Plasma Glucose Level(Baseline and Weeks 14, 54, 106, and 158)
- Percentage of Participants Who Achieve an HbA1c of <7.0%(Weeks 106 and 158)
- Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%(Weeks 54, 106 and 158)