A Double-blind, Placebo-controlled, Multiple-Dose, 2-Period Crossover Study to Evaluate the Effect of Steady-state AZD6793 on the Steady-state Pharmacokinetics and Pharmacodynamics of Metformin in Participants With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- AstraZeneca
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Mean glucose levels
研究概览
简要总结
The purpose of this study is to examine the effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants with Type 2 Diabetes Mellitus.
详细描述
This is a double-blind, placebo-controlled, 2-period cross-over study conducted at a single study centre to assess the pharmacokinetics and pharmacodynamics (ie, glucose lowering effect) of metformin in participants with T2DM when metformin is administered alone and in combination with multiple doses of AZD6793. This study will consist of 2 treatment periods separated by a washout period of 7 to 14 days.
Approximately 28 eligible participants will be randomized to study intervention such that 24 evaluable participants complete the study (12 participants in each treatment sequence).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Investigators, site staff, sponsor and their representatives will remain blinded to each participant's assigned study intervention throughout the course of the study. In order to maintain this blind, an otherwise uninvolved 3rd party will be responsible for the reconstitution and dispensation of all study intervention and will endeavor to ensure that there are no differences in time taken to dispense following randomization.
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
- •Physician-diagnosis of T2DM
- •On a stable dose of metformin 2000 mg per day for at least 3 months prior to screening.
- •stable glycaemic control indicated by no change in treatment for diabetes within 3 months prior to screening
- •HbA1c (Hemoglobin A1c) ≤ 8.5% at screening
- •Body Mass Index (BMI) within the range 18.5 to 35 kg/m2 , inclusive, at screening.
排除标准
- •Physician diagnosis of type 1 diabetes.
- •History of any clinically important disease or disorder.
- •History or presence of chronic Gastrointestinal, hepatic, renal, or pancreatic disease
- •History of Human immunodeficiency viruses (HIV) infection or a positive HIV test.
- •History of prior episode(s) of lactic acidosis.
研究组 & 干预措施
Treatment B
Placebo and metformin
干预措施: AZD6793 Placebo (Drug)
Treatment A
AZD6793 and metformin
干预措施: AZD6793 (Drug)
结局指标
主要结局
Mean glucose levels
时间窗: Day 7
Mean glucose levels on Day 7 of each treatment period as assessed by Continuous Glucose Monitoring (CGM)
次要结局
- CGM Metric (Time in range)(Day 7 of each treatment period)
- CGM Metric (Time in tight range)(Day 7 of each treatment period)
- CGM Metric (time below range)(Day 7 of each treatment period)
- CGM Metric (time above range)(Day 7 of each treatment period)
- CGM Metric (AUC(0-24))(Day 7 of each treatment period)
- CGM Measure (Plasma fasting glucose)(Day 7 of each treatment period)
- CGM Measure (AUC(0-4) after each meal)(Day 7 of each treatment period)
- CGM Measure (Total glucose AUC(0-24))(Day 7 of each treatment period)
- Metformin Plasma PK (AUC(0-12))(Day 7 of each treatment period)
- Metformin Plasma PK (Cmax)(Day 7 of each treatment period)
- Metformin Plasma PK (tmax)(Day 7 of each treatment period)
- Metformin Plasma PK (t1/2λz)(Day 7 of each treatment period)
- Metformin Plasma PK (CL/F)(Day 7 of each treatment period)
- Metformin Plasma PK (Vz/F)(Day 7 of each treatment period)
- Metformin Plasma PK (R AUC(0-12))(Day 7 of each treatment period)
- Metformin Plasma PK (R Cmax)(Day 7 of each treatment period)
- Metformin Urine PK (Ae(0-12))(Day 7 of each treatment period)
- Metformin Urine PK (fe(0-12))(Day 7 of each treatment period)
- Metformin Urine PK (CLR)(Day 7 of each treatment period)
- AZD6793 plasma PK (AUC(0-24))(Days 1 through 7 of each treatment period)
- AZD6793 plasma PK (Cmax)(Days 1 through 7 of each treatment period)
- AZD6793 plasma PK (tmax)(Days 1 through 7 of each treatment period)
- AZD6793 plasma PK (t1/2λz)(Days 1 through 7 of each treatment period)
- AZD6793 plasma PK (Ctrough)(Days 1 through 7 of each treatment period)
- AZD6793 plasma PK (Rac AUC(0-24))(Days 1 through 7 of each treatment period)
- AZD6793 plasma PK (Rac Cmax)(Days 1 through 7 of each treatment period)