A 12-Week,Double-Blind, Placebo-Controlled Trial of LY2428757 in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint
研究概览
简要总结
A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet and exercise alone, or in combination with metformin, will be enrolled. The primary objective of this study is to test the hypothesis that LY2428757 given to patients with T2DM inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week safety follow-up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Have type 2 diabetes mellitus for at least 6 months prior to entering the trial.
- •Treated with diet and exercise alone or in combination with at least 1000 milligrams (mg)/day of metformin for at least 2 months prior to screening.
- •Have a glycosylated fraction of hemoglobin A (HbA1c) value of 7.0% - 10.0% at screening
- •Women of child-bearing potential must test negative for pregnancy at screening and agree to abstain from heterosexual intercourse for the duration of the study, or use 2 effective forms of birth control during the study.
- •Have a body mass index (BMI) between 25 and 40 kilograms per square meters kg/m^2) at screening
- •Stable weight during the 3 months prior to screening.
排除标准
- •Use any antidiabetic agent other than metformin during the 2 months prior to screening.
- •Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone bariatric surgery.
- •Are currently taking prescription or over-the counter medications to promote weight loss.
- •Have been previously diagnosed with pancreatitis
- •Women who are breastfeeding.
- •Have a history of myocardial infarction, unstable angina, coronary artery bypass graft (CABG), percutaneous coronary intervention, transient ischemic attack, stroke or decompensated congestive heart failure in the past 6 months.
- •Have poorly controlled hypertension
研究组 & 干预措施
0.5 mg LY2428757
Once weekly, subcutaneous injection of 0.5 milligram (mg) LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
干预措施: LY2428757 (Drug)
2.0 mg LY2428757
Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
干预措施: LY2428757 (Drug)
6.2 mg LY2428757
Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
干预措施: LY2428757 (Drug)
12.0 mg LY2428757
Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
干预措施: LY2428757 (Drug)
17.6 mg LY2428757
Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
干预措施: LY2428757 (Drug)
Placebo
Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Hemoglobin A1C (HbA1c) From Baseline to Week 12 Endpoint
时间窗: baseline, 12 weeks
LSMean adjusted for baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction.
次要结局
- Change in Visual Analogue Scales (VAS) For Appetite and Satiety From Baseline to Week 12 Endpoint(baseline, 12 weeks)
- Number of Participants With Detectable Antibodies To LY2428757 At Any Time During The Study(baseline through 16 weeks)
- Total Average Concentration (Cavg) of LY2428757(4 weeks, 6 weeks, 8 weeks, 10 weeks)
- Change in 7-Point Self-Monitored Glucose From Baseline to Week 12 Endpoint(baseline, 12 weeks)
- Change in Total Glucose Area Under the Curve (AUC) From Baseline to Week 12 Endpoint(baseline, 12 weeks)
- Change in Insulin Total Area Under the Curve (AUC) From Baseline to Week 12 Endpoint(baseline, 12 weeks)
- Change in C-peptide Area Under the Curve (AUC) From Baseline to Week 12 Endpoint(baseline, 12 weeks)
- Change in Fasting Lipids From Baseline to Week 12 Endpoint(baseline, 12 weeks)
- Change in Fasting Weight From Baseline to Week 12 Endpoint(baseline, 12 weeks)
- Change in Impact of Weight on Quality of Life - Lite (IWQoL-Lite) Average Score From Baseline to Week 12 Endpoint(baseline, 12 weeks)
- Change in Diabetes Symptom Checklist-Revised (DSC-R) Average Score From Baseline to Week 12 Endpoint(baseline, 12 weeks)
- Change in European Quality of Life (EuroQol)- Visual Analog Scale From Baseline to Week 12 Endpoint(baseline, 12 weeks)
- Percent of Participants Domain Scores Indicating No Problems on European Quality of Life (EuroQol) at Baseline and Week 12 Endpoint(Baseline, 12 Weeks)