A Phase III, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
- 主要终点
- Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30
研究概览
简要总结
The primary objectives of this study are to determine if sitagliptin treatment is not inferior to that of glimepiride as measured by the change in baseline hemoglobin A1C (HbA1C) after 30 weeks of treatment, and if sitagliptin treatment results in a lower incidence of symptomatic hypoglycemia compared to that of glimepiride. The study will also evaluate if sitagliptin treatment, compared to glimepiride results in improvements in fasting plasma glucose (FPG) levels, and plasma lipid levels after 30 weeks of treatment. Participants will be randomized to either sitagliptin or glimepiride treatment after eligibility for study participation is determined during screening and washout study phases. Participants and study staff will not know to which treatment group they have been randomized (double-blind design). The duration of study participation will be up to 40 weeks (with 9 clinic visits). This will include a screening phase (Visit 1 to Visit 2) of 2 weeks maximum; a 6-week (Visits 2 to 3) oral antihyperglycemic agent (AHA) wash-out phase (for those who have been taking a AHA prior to the study); a placebo run-in phase (Visits 3 to 4), followed by up to 30 weeks of treatment with study medication.
详细描述
The dose of sitagliptin will be 100 mg once daily (QD) or 50 mg QD based on the participant's estimated glomerular filtration rate (eGFR). The starting dose of glimepiride (1 mg QD) may be up-titrated as needed to optimize glycemic control over the first 18 weeks to a maximum dose of 6 mg/day, after which the dose will not be increased for the rest of the study (down-titration to avoid or control hypoglycemia is allowed).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sitagliptin
Sitagliptin phosphate 100 mg or 50 mg once daily (QD)
干预措施: sitagliptin phosphate (Drug)
Sitagliptin
Sitagliptin phosphate 100 mg or 50 mg once daily (QD)
干预措施: Placebo to Glimepiride (Drug)
Glimepiride
Glimepiride 1-6 mg QD
干预措施: Glimepiride (Drug)
Glimepiride
Glimepiride 1-6 mg QD
干预措施: Placebo to Sitagliptin (Drug)
结局指标
主要结局
Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30
时间窗: Baseline and Week 30
Participant whole blood samples were collected at baseline and Week 30 to determine the LS mean HbA1c change from baseline. HbA1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.
Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30
时间窗: Up to Week 30
Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level. Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia. If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL. In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms.
Number of Participants Experiencing An Adverse Event (AE)
时间窗: Up to Week 30
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered.
Number of Participants Discontinuing Study Treatment Due to An AE
时间窗: Up to Week 30
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment administered.
次要结局
- LS Mean Change From Baseline in Participant Body Weight at Week 30(Baseline and Week 30)
- LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30(Baseline and Week 30)
- Percentage of Participants With HbA1c <7.0% at Week 30(Week 30)
- Percentage of Participants With HbA1c <6.5% at Week 30(Week 30)