NCT00509236已完成3 期
A Multicenter, Randomized Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease Who Are on Dialysis and Who Have Inadequate Glycemic Control
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 129
- 主要终点
- Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment
研究概览
简要总结
The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who do not have adequate glycemic control.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has T2DM.
- •Participant is on dialysis on day of signing informed consent.
- •Participant is unlikely to conceive or uses acceptable methods of birth control: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.
- •Participant has hemoglobin A1c ≥7% and ≤9% measured at or within 2 weeks prior to Visit 4/Week -
- •Participant is ≥85% compliant with study medication during the single-blind placebo run-in (as determined by tablet/capsule count) and compliant with diet, exercise and other run-in treatments during the run-in period.
排除标准
- •Participant has a history of type 1 diabetes mellitus or a history of ketoacidosis.
- •Participant is losing weight in a weight loss program and is not in the maintenance phase (defined as <2 kg weight loss in 2 months), or intends to be involved in weight loss intervention outside that prescribed by the study.
- •Participant has a clinically significant hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
- •Participant has cirrhosis or active liver disease.
- •Participant has been on dialysis for < 6 months.
- •Participant has been diagnosed with a significant cardiovascular disorder and has new or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent.
- •Participant has severe active peripheral vascular disease.
- •Participant has a history of malignancy ≤ 5 years prior to signing informed consent, or > 5 years without documentation of remission/cure.
- •Participant is under treatment for hyperthyroidism.
- •Participant has a hypersensitivity or contraindication to glipizide.
研究组 & 干预措施
Sitagliptin 25 mg
Experimental
干预措施: Sitagliptin (Drug)
Glipizide 2.5 mg - 20 mg
Active Comparator
干预措施: Glipizide (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c After Sitagliptin Treatment
时间窗: Baseline / Week 54
Change from baseline in mean hemoglobin A1c after treatment with sitagliptin for 54 weeks. Hemoglobin A1c is the percent of hemoglobin that is glycated. Results for the glipizide arm are not reported in this table because the primary outcome measure is for the sitagliptin arm only.
Number of Participants With Clinical Adverse Events
时间窗: 54 Week Treatment Period + 28 days
Reported experiences assessed by investigators as adverse events, excluding data after initiation of glycemic rescue therapy.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline / Week 54)
- Number of Participants With Symptomatic Hypoglycemic Adverse Events(54 Week Treatment Period + 28 days)
- Change From Baseline in Hemoglobin A1c for Sitagliptin Versus Glipizide Treatment(Baseline / Week 54)
研究者
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