NCT01001104已完成2 期
Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Japanese Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks
研究概览
简要总结
The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients with type 2 diabetes with a body mass index (BMI)≥18.5 kilograms per square meter (kg/m^2) but <40.0 kg/m^
- •Patients who are oral antidiabetic drug (OAD) naïve or are taking OAD monotherapy except for a dipeptidyl peptidase-4 inhibitor (DPP-IV) and are willing to discontinue their OAD.
- •Patients who are OAD naïve with screening glycosylated hemoglobin (HbA1c) value of 7.0% to 9.5% and randomization HbA1c value of 7.0% to 9.5%, or who are taking OAD monotherapy with screening HbA1c value of 6.0% to 8.5% and randomization HbA1c value of 7.0% to 9.5%.
- •Patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening.
排除标准
- •Patients who are currently taking prescription medications to promote weight loss
- •Patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening.
- •Patients who have a known clinically significant gastrointestinal disorder, have undergone excision of all or any part of the gastrointestinal tract, have undergone gastric bypass surgery for treatment of obesity, or chronically take drugs that directly influence gastrointestinal motility.
- •Patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension.
- •Patients who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis. Patients who have amylase and/or lipase of 1.5 times or more the upper limit of the reference range.
- •Have a family history, obvious clinical signs, or symptoms of medullary carcinoma of thyroid.
研究组 & 干预措施
0.75 mg LY2189265
Experimental
干预措施: LY2189265 (Drug)
0.5 mg LY2189265
Experimental
干预措施: LY2189265 (Drug)
0.25 mg LY2189265
Experimental
干预措施: LY2189265 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks
时间窗: Baseline, 12 weeks
Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect.
次要结局
- Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks(up to 12 weeks)
- Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks(up to 12 weeks)
- Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks(Baseline, 12 weeks)
- Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks(Baseline, 12 weeks)
- Change From Baseline in Total Body Weight at 12 Weeks(Baseline, 12 weeks)
- Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks(Baseline, 12 weeks)
- Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks(Baseline, 12 weeks)
- Steady-State Concentrations of LY2189265(12 weeks)
- Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period(12 weeks)
研究者
研究点 (1)
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