A Multi-Center, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Panel Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Number of Participants Discontinuing Study Treatment Due to an AE
研究概览
简要总结
This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Not currently on antihyperglycemic agent (AHA) or AHA monotherapy (not to include treatment with insulin or thiazolidinediones [i.e., peroxisome proliferator activated receptor-gamma, PPARγ agents])
- •male or a female of non-childbearing potential. Women must be postmenopausal or premenopausal and documented surgically sterilized
- •A body mass index (BMI) that is > 20 and ≤ 40 kg/m2
排除标准
- •History of type 1 diabetes or assessed by the investigator as possibly having type 1 diabetes
- •History of ketoacidosis; clinically unstable or rapidly progressive diabetic retinopathy, nephropathy, neuropathy
- •Treatment for diabetes within 3 months of study participation with combination anti-hyperglycemic therapy, insulin or thiazolidinediones (e.g., rosiglitazone or pioglitazone)
- •oral corticosteroid medications within 2 weeks prior to study participation, or requires digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies
- •History of acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV)
- •History of gastrointestinal problems or disorders or extensive bowel or gastric surgery
- •History of significant or unstable cardiovascular disease
- •History of neoplastic disease
- •History of hepatic disease
- •History of seizures, epilepsy or other neurologic disease
- •History of myelodysplastic or pre-leukemic disorders or other severe hematological disorder
研究组 & 干预措施
MK-0893 (40 mg)
MK-0893 40-mg q.d. (quaque die, once daily) group will receive MK-0893 40-mg tablets (after loading dose with 160 mg) and matching placebo to metformin and matching placebo to MK-0893.
干预措施: MK-0893 (Drug)
MK-0893 (40 mg)
MK-0893 40-mg q.d. (quaque die, once daily) group will receive MK-0893 40-mg tablets (after loading dose with 160 mg) and matching placebo to metformin and matching placebo to MK-0893.
干预措施: Placebo (Drug)
MK-0893 (120 mg)
MK-0893 at 120 mg q.d. group will receive MK-0893 120 mg q.d. tablets (after loading dose of 500 mg on Day 1) and matching placebo tablets to metformin and matching placebo to MK-0893
干预措施: MK-0893 (Drug)
MK-0893 (120 mg)
MK-0893 at 120 mg q.d. group will receive MK-0893 120 mg q.d. tablets (after loading dose of 500 mg on Day 1) and matching placebo tablets to metformin and matching placebo to MK-0893
干预措施: Placebo (Drug)
Metformin (2000 mg)
Metformin taken orally, 500 mg tablets, Day 1 to Day 6: 500 mg b.i.d. (bis in die, twice daily), Day 7 to Day 13: 1000 mg in the morning and 500 mg in the evening, and Day 14 to Day 28: 1000 mg. b.i.d. and matching placebo to MK-0893.
干预措施: Metformin (Drug)
Metformin (2000 mg)
Metformin taken orally, 500 mg tablets, Day 1 to Day 6: 500 mg b.i.d. (bis in die, twice daily), Day 7 to Day 13: 1000 mg in the morning and 500 mg in the evening, and Day 14 to Day 28: 1000 mg. b.i.d. and matching placebo to MK-0893.
干预措施: Placebo (Drug)
Placebo
Placebo tablets matching the MK-0893 and placebo tablets matching metformin.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Discontinuing Study Treatment Due to an AE
时间窗: Up to 28 days
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Number of Participants Experiencing an Adverse Event (AE)
时间窗: Up to 42 days
An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.
Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4
时间窗: Baseline and Week 4
Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period.
次要结局
- Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4(Baseline and Week 4)
- Change From Baseline in Fructosamine at Week 4(Baseline and Week 4)
- Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline and Week 4)
- Change From Baseline in Fasting Insulin at Week 4(Baseline and Week 4)
- Change From Baseline in 3-hour Insulin Total AUC at Week 4(Baseline and Week 4)
- Change From Baseline in Fasting C-peptide at Week 4(Baseline and Week 4)
- Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4(Baseline and Week 4)
- Change From Baseline in 3-hour AUC for C-peptide at Week 4(Baseline and Week 4)