NCT02942914已完成1 期
A First-in-Human, Ascending-Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of a Single, Subcutaneous Dose of LY3209590
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 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
This trial is conducted to evaluate the safety of a study drug given by injection under the skin to healthy participants and participants with type 2 diabetes. It will also investigate how the body processes the study drug and the effect of the study drug on blood sugar levels. Information about any side effects and tolerability will be documented. This study is approximately 30 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all study participants:
- •Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes for at least 1 year
- •Male participants with female partners who can become pregnant must agree to use an effective method of birth control during the study and for 4 months after study drug dosing
- •Have a body mass index (BMI) of greater than 18.5 kilogram per square meter (kg/m²) and less than or equal to 35 kg/m² at screening
- •Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
- •Have venous access sufficient to allow blood sampling
- •For participants with Type 2 Diabetes Mellitus (T2DM):
- •Have T2DM controlled with diet and exercise alone or are stable on metformin for at least 30 days
- •If taken, prescription medications for medical conditions (e.g.antihypertensive agents, aspirin or lipid lowering agents) are stable for at least 4 weeks
- •Have a hemoglobin A1c (HbA1c) greater than or equal to 7.0% and less than or equal to 9.5%
排除标准
- •For all study participants:
- •Are currently participating in another clinical study
- •Have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction
- •Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
- •Have donated blood or have had a loss of 500 milliliters (mL) or more in the last 3 months or have had any blood donation within the last month from screening
- •Intend to start any new over-the-counter or prescription medications 7 and 14 days before planned dosing
- •For participants with T2DM:
- •Have taken any glucose-lowering medications, other than metformin, including insulin, in the past 3 months before screening
- •Have had more than 1 episode of severe hypoglycemia, within 6 months before entry into the study, or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
- •Have had a blood transfusion or severe blood loss in the past 3 months, or any blood disorder that could interfere with the understanding of the results of the study
- •Have received chronic (lasting greater than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, and inhaled preparations) in the 3 past months, or have received any glucocorticoid therapy within 30 days before screening
研究组 & 干预措施
LY3209590
Experimental
LY3209590 administered subcutaneously (SC).
干预措施: LY3209590 (Drug)
Placebo
Placebo Comparator
Placebo (sterile saline) administered SC.
干预措施: Placebo (Drug)
Insulin Glargine (Lantus)
Active Comparator
Insulin Glargine administered SC.
干预措施: Insulin Glargine (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 Day 31
次要结局
- Pharmacokinetics: Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) of LY3209590(Baseline through Day 31)
- Pharmacodynamics: Average Glucose from 8-Point Glucose Profiles in Participants with T2DM treated with Placebo or LY3209590(Day 3)
研究者
研究点 (1)
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