A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Crossover Study to Assess the Safety and Tolerability of MK0893 Coadministered With Propranolol Hydrochloride in Patients With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Recovery Time (Rt[65] From Insulin-induced Hypoglycemia
研究概览
简要总结
This study will assess the effect of combined treatment with MK0893 plus propranolol versus placebo plus propranolol on hypoglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has Type 2 Diabetes (T2DM)
- •Participant is either: Not on an oral antihyperglycemic medication for at least 6 weeks; on a single oral antihyperglycemic medication that is not a peroxisome proliferator-activated gamma (PPAR-gamma) agonist (e.g. Avandia); OR on a combination of no more than two antihyperglycemic medications that are not PPAR-gamma) agonists
- •Participant has not received insulin for at least 6 months
- •Participant has not been treated with a PPAR-gamma agonist for at least 12 weeks
- •Participant has been a nonsmoker for at least 6 months
- •Female participants who are non-pregnant and highly unlikely to conceive due to surgical sterilization, post-menopausal status, not heterosexually active, or willing to use 2 birth control methods
排除标准
- •Participant has a history of stroke, seizures, or neurological disorders
- •Participant cannot tolerate insulin or propranolol
- •Participant has a history of asthma, emphysema or chronic bronchitis
- •Participant is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication within 8 weeks of screening
- •Participant is on or may require treatment with drugs that affect the immune system or with corticosteroids
- •Participant has a history of heart failure or coronary artery disease
- •Participant has a history of uncontrolled high blood pressure
- •Participant is Human Immunodeficiency (HIV), hepatitis B or hepatitis C positive
- •Participant has a history of Type 1 diabetes
- •Participant has a history of hypoglycemia unawareness documented by a blood glucose concentration < 55 mg/dL (3.1 mol/L) without symptoms of hypoglycemia.
研究组 & 干预措施
Propanolol + Placebo > Propanolol + MK0893
Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893-matched placebo was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8).
干预措施: MK0893 (Drug)
Propanolol + Placebo > Propanolol + MK0893
Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893-matched placebo was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8).
干预措施: MK0893-matched Placebo (Drug)
Propanolol + Placebo > Propanolol + MK0893
Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893-matched placebo was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8).
干预措施: Propranolol Hydrochloride (HCL) (Drug)
Propanolol + MK0893 > Propanolol + Placebo
Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893 was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8).
干预措施: MK0893 (Drug)
Propanolol + MK0893 > Propanolol + Placebo
Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893 was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8).
干预措施: MK0893-matched Placebo (Drug)
Propanolol + MK0893 > Propanolol + Placebo
Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893 was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8).
干预措施: Propranolol Hydrochloride (HCL) (Drug)
结局指标
主要结局
Recovery Time (Rt[65] From Insulin-induced Hypoglycemia
时间窗: From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes
Rt(65) defined as the time to recover from hypoglycemia (blood glucose level of 50 mg/dL) to an arterialized venous blood glucose of 65 mg/dL. At t= -60 minutes on the morning of Day 1 (Visit 6) or Day 22 (Visit 8), a hypoglycemic clamp was used via an increased insulin infusion rate to achieve blood glucose concentrations of 50 mg/dL (2.8 mmol/L) within \~30-90 minutes. At the end of the 30-minute hypoglycemic clamp interval, insulin and glucose infusions were terminated, and the time to recover from hypoglycemia to 65 mg/dL Rt(65) was determined. Rt(65) was followed up to 270 minutes
次要结局
- Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893(From time of MK0893 administration through estimated 32 hours post-dose)
- Number of Participants With An Adverse Event (AE)(From time of administration of study treatment through end of Post-Study (up to 21 days after administration of last dose of study treatment).)
- Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893(From time of MK0893 administration through 24 hours post-dose)
- Number of Participants Who Discontinued Study Treatment Due To AEs(From time of first administration of study treatment to time of last administration of study treatment (up to Day 21))