Sitagliptin Study in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 91
- 主要终点
- Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are at least 18 years of age diagnosed with type 2 diabetes mellitus (T2DM) (a specific type of diabetes).
- •Patient has renal (kidney) insufficiency (inadequate kidney function)
排除标准
- •Patient has had heart problems (such as a heart attack or chest pain) or stroke within the past 6 months or any condition or therapy which, in the opinion of the investigator, may not be in the patient's best interest to participate.
- •Pregnant or breast feeding
研究组 & 干预措施
Sitagliptin
Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B.
干预措施: sitagliptin (Drug)
Sitagliptin
Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B.
干预措施: glipizide (Drug)
Sitagliptin
Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B.
干预措施: Placebo to glipizide (Drug)
Placebo
Participants in the Placebo treatment sequence will receive placebo to sitagliptin in Phase A and glipizide in Phase B.
干预措施: Placebo to Sitagliptin (Drug)
Placebo
Participants in the Placebo treatment sequence will receive placebo to sitagliptin in Phase A and glipizide in Phase B.
干预措施: glipizide (Drug)
结局指标
主要结局
Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment
时间窗: Week 0 through Week 12
Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.
次要结局
- Safety and Tolerability of Sitagliptin Over 54 Weeks(Week 0 through Week 54)