Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of LY2922470 in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The main purpose of this study is to determine the safety of LY2922470, taken as oral capsules, once or twice daily for approximately 28 days, in participants with diabetes. It also aims to determine how long the drug stays in the body and how it affects blood sugar levels. A screening appointment is required within 28 days before the start of the study and a follow up appointment is required approximately 14 days after the last study dose is taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Must be a male, or a female who cannot become pregnant, and who has type 2 diabetes
- •Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening
- •Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening
- •Have a screening body mass index (BMI) of 18.0 to 45.0 kilograms per square meter (kg/m^2)
- •Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
排除标准
- •Are currently participating in another clinical study or completed one in the last 30 days
- •Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
- •Have electrocardiogram (ECG) readings that are not suitable for the study
- •Are infected with hepatitis B or hepatitis C
- •Are infected with human immunodeficiency virus (HIV)
- •Have donated blood equal to or more than 500 mL within 56 days before the first dose of drug or have donated plasma within 7 days before the first dose or provided any blood donation within the last month from screening
研究组 & 干预措施
Placebo
Multiple oral dose of placebo administered to participants with diabetes once or twice daily for 28 days
干预措施: Placebo (Drug)
LY2922470
Multiple ascending dose of LY292470 (starting at 60 mg) administered orally to participants with diabetes once or twice daily for 28 days
干预措施: LY2922470 (Drug)
结局指标
主要结局
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Study Completion (up to 56 days)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.
次要结局
- Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470(Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose)
- Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470(Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose)
- Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28(Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose)
- Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28(Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose)
- Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470(Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose)
- Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28(Baseline, Day 28)