A Randomized, Crossover Study Assessing the Effect of EFB0027 on Plasma Glucose and Pharmacokinetics in Subjects With Type 2 Diabetes Mellitus
概览
- 阶段
- 1 期
- 干预措施
- Met DR
- 疾病 / 适应症
- Type 2 Diabetes Mellitus
- 发起方
- Elcelyx Therapeutics, Inc.
- 入组人数
- 26
- 主要终点
- AUC (0-24) of Plasma Metformin
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
This study compared the effects of delayed-release metformin (Met DR, EFB0027) administered once daily in the morning (qAM), administered once daily in the evening (qPM), and administered twice daily (BID) on circulating glucose concentrations and metformin pharmacokinetics (PK) in subjects with type 2 diabetes mellitus (T2DM).
研究者
入排标准
入选标准
- •18 to 70 (inclusive) years old at Visit 1 (Screening)
- •Was diagnosed with type 2 diabetes mellitus with
- •HbA1c between 6.0 to 9.5% (inclusive) for subjects managing their diabetes with:
- •i. Diet and exercise alone, or ii. A stable regimen (minimum of 2 months at Visit 1) of metformin alone, or iii. A stable regimen (minimum of 2 months at Visit 1) of DPP-4 inhibitor alone OR
- •HbA1c between 6.0 to 8.5% (inclusive) for subjects managing their diabetes with a stable (minimum of 2 months at Visit 1) combination regimen of metformin and DPP-4 inhibitors
- •Had normal renal function with an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73 m\^2 based on the Modification of Diet in Renal Disease (MDRD) equation
- •Body mass index (BMI) of 25.0 to 40.0 kg/m\^2 (inclusive) at Screening
- •Male, or if female and met all of the following criteria:
- •Not breastfeeding
- •Negative pregnancy test result (human chorionic gonadotropin, beta subunit) at Visit 1 (Screening) (not applicable to hysterectomized females)
排除标准
- •Had a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
- •Hepatic disease
- •Renal disease
- •Gastrointestinal disease
- •Endocrine disorder except diabetes
- •Cardiovascular disease
- •Central nervous system diseases
- •Psychiatric or neurological disorders
- •Organ transplantation
- •Chronic or acute infection
研究组 & 干预措施
500 mg Met DR BID
Two doses of 500 mg metformin delayed-release
干预措施: Met DR
1000 mg Met DR qAM
One dose of 1000 mg metformin delayed-release in the morning
干预措施: Met DR
1000 mg Met DR qPM
One dose of 1000 mg metformin delayed-release in the evening
干预措施: Met DR
结局指标
主要结局
AUC (0-24) of Plasma Metformin
时间窗: Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.
AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.
AUC (0-24) of Plasma Glucose
时间窗: Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the time of the standardized dinner.
AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.
Cmax of Plasma Metformin
时间窗: Times points to determine Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.
Cmax = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.
Rmax (0-24) of Plasma Glucose
时间窗: Times points to determine Rmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.
Rmax (0-24) = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.