A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release on Glucose Control (HbA1c) and Safety in Subjects With Type 2 Diabetes Mellitus Managed With Diet Modification and Exercise and/or Oral Antidiabetic Medications
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 303
- 试验地点
- 23
- 主要终点
- Change in HbA1c From Baseline to Week 30
研究概览
简要总结
A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic Medications.
详细描述
This trial is designed to examine the effect of exenatide once weekly compared to exenatide twice daily on glucose control and safety in subjects for at least 30 weeks. The study is also designed to examine glucose control during the transition from exenatide twice daily for 30 weeks to exenatide once weekly. Long-term safety and efficacy will be monitored during the open-ended assessment periods. This study will be conducted in approximately 300 subjects with type 2 diabetes treated with diet modification and exercise alone or in combination with a stable regimen of metformin, SU, thiazolidinedione (TZD), a combination of metformin and SU, a combination of metformin and TZD, or a combination of SU and TZD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has type 2 diabetes mellitus treated with diet modification and exercise alone or in combination with a stable regimen of a combination of metformin, sulphonylureas, and thiazolidinediones for a minimum of 2 months at screening.
- •Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
- •Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
- •(For sub-study) Currently participating in open ended assessment period of main study 2993 LAR105
排除标准
- •Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any glucagon-like peptide-1 (GLP-1) analog.
- •Received any investigational drug or has participated in any type of clinical trial within 30 days prior to screening.
- •Has been treated, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications:
- •Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
- •Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
- •Regular use (> 14 days) of drugs that directly affect gastrointestinal motility;
- •Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption;
- •Regular use (> 14 days) of medications with addictive potential such as opiates and opioids;
- •Prescription or over-the-counter weight loss medications within 6 months of screening.
- •(For sub-study) Subjects will be terminated from study who do not participate in the dual chamber pen substudy
研究组 & 干预措施
Exenatide Once Weekly
Subcutaneous injection (SC), once a week of long acting release (LAR) exenatide.
干预措施: exenatide, long acting release (Drug)
Exenatide Twice Daily
subcutaneous injection (SC), twice a day for the first 30 weeks, followed by exenatide LAR SC injection weekly for the remainder of the study.
Sub-study: Exenatide 2 mg subcutaneous injection, Administered Using the Exenatide Once Weekly Single-Dose Tray , once a week for 11 visits, switch to Exenatide 2 mg subcutaneous injection, Administered Using the Dual chamber pen device. Exenatide 2mg SC injection administered using the Dual chamber pen device.
干预措施: exenatide (Drug)
结局指标
主要结局
Change in HbA1c From Baseline to Week 30
时间窗: Day -3, Week 30
Absolute change in HbA1c from Baseline (Day -3) to Week 30 \[Week 30 - Baseline\]
Sub-study Relative Bioavailability of Exenatide When Administered Using the Exenatide Once Weekly Dual Chambered Pen and the Exenatide Once Weekly Single Dose Tray (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)
时间窗: Week 22
Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval
次要结局
- Change in HbA1c From Baseline to Week 364(Day -3, Week 364)
- Percentage of Subjects Achieving HbA1c Target of <7%(Week 364)
- Percentage of Subjects Achieving HbA1c Target of <=6.5%(Week 364)
- Percentage of Subjects Achieving HbA1c Target of <=6.0%(Week 30)
- Exenatide LAR Steady State Concentration From Week 29 to Week 30(Week 29 to Week 30)
- Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14(Day -3, Week 14)
- Sub-study Safety and Tolerability of Exenatide When Administered Using the Once Weekly Single Dose Tray and the Once Weekly Dual (Single Dose Tray-11 Weekly Doses Switch to Dual Chamber Pen-11 Weekly Dose)(Week 22)
- Change in Body Weight From Baseline to Week 30(Day -3, Week 30)
- Change in Fasting Plasma Glucose From Baseline to Week 30(Day -3, Week 30)
- Change in Blood Pressure From Baseline to Week 30(Day -3, Week 30)
- Change in Body Weight From Baseline to Week 364(Day -3, Week 364)
- Change in Fasting Plasma Glucose From Baseline to Week 364(Day -3, Week 364)
- Change in Total Cholesterol From Baseline to Week 364(Day -3, Week 364)
- Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364(Day -3, Week 364)
- Ratio of Triglycerides at Week 30 to Baseline(Day -3, Week 30)
- Ratio of Triglycerides at Week 364 to Baseline(Day -3, Week 364)
- Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening(Day 1 to Week 364)
- Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening(Day 1 to Week 364)
- Change in Blood Pressure From Baseline to Week 364(Day -3, Week 364)
- Change in Total Cholesterol From Baseline to Week 30(Day -3, Week 30)
- Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30(Day -3, Week 30)
- Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364(Day -3, Week 364)