Acute Effect of a GLP-1-Analogue (Exenatide) and of a DPP-4-Inhibitor (Sitagliptin) in Subjects With Type 2 Diabetes Treated With Insulin Glargine Once Daily
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast
研究概览
简要总结
This study investigated a 4-week adjunctive therapy of either a GLP-1 analog (exenatide), or a DPP-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and their effect on blood glucose control, versus insulin glargine alone as active comparator in type 2 diabetes.
详细描述
Due to the different mechanisms of action of the long-acting insulin analog insulin glargine and both a GLP-1 analog (exenatide) and a DPP-4-inhibitor (sitagliptin), it could be a promising approach to combine insulin glargine with either exenatide or sitagliptin for optimum control of fasting and postprandial blood glucose values. Thus, in the present study the influence of either exenatide or sitagliptin as a 4-week adjunctive therapy to a basal insulin (insulin glargine) was investigated versus insulin glargine alone as active comparator in subjects with type 2 diabetes. Preexisting metformin was continued, sulfonylureas, if any, were stopped. In particular, the effects on postprandial blood glucose excursion following ingestion of a standard breakfast, assessed after 4 weeks of treatment, the effects on mean daily blood glucose, on self-measured 7-point profiles, the percentage of subjects reaching ADA treatment goals (HbA1c < 7.0%) at the end of treatment, on fasting lipid profile, on HOMA index, weight, hypoglycemic episodes and general safety were assessed. The study consisted of a screening visit, a 4-8 week (depending on pre-treatment) run-in period, a 4-week treatment period, and a follow-up visit. There were weekly visits at the site and twice weekly telephone contacts.
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
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female subjects aged between 35 and 70 years, inclusive
- •type 2 diabetes with duration >6 months and <10 years
- •for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or NPH insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas
- •HbA1c >=7.0% and <=10.0%
- •if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start
- •written informed consent
排除标准
- •history or presence of cancer or any clinically relevant diseases
- •chronic heart failure NYHA class III or IV, unstable angina pectoris or myocardial infarction within the previous 6 months
- •recurrent hypoglycemia
- •abnormal lab tests at screening (ALAT and/or ASAT >=3 times ULN), creatinine >1.6 mg/dL in males and >1.4 mg/dL in females
- •clinically relevant ECG findings at screening
- •treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months
- •treatment with any other OHA than metformin or metformin plus sulfonylureas during the previous 3 months
- •any systemic or topical treatment with drugs known to influence glucose metabolism
研究组 & 干预措施
insulin glargine + exenatide + metformin
干预措施: insulin glargine + exenatide + preexisting metformin (Drug)
Insulin glargine + sitagliptin + metformin
干预措施: insulin glargine + sitagliptin + preexisting metformin (Drug)
insulin glargine + metformin
干预措施: insulin glargine + preexisting metformin (Drug)
结局指标
主要结局
the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast
时间窗: after 4 weeks of treatment
次要结局
- mean daily blood glucose (BG) from 7-point 24h BG profiles, fasting BG, self-measured 7-point BG profiles, percentage of subjects achieving ADA HbA1c treatment goals, fasting lipid profiles, HOMA-IR index, hypoglycemic episodes(after 4 weeks of treatment)