Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology and Metabolic Control in Patients With Type 2 Diabetes Mellitus on Stable Metformin Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- • Change in glucagon release (AUC0-180 min) during Liquid Meal Test (LMT) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo)
研究概览
简要总结
The primary aim of this exploratory mechanistic study is to investigate the effects of Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients.
This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell function, as well as several markers of metabolic control.
详细描述
This study will be performed as a multi-center study which includes 2 centres. 44 subjects with T2DM are to be included according to the defined in- and exclusion criteria.
Subjects has to be on a stable metformin therapy and will receive in a first step empagliflozin for 30 days. Both therapies (metformin and empagliflozin) will be continued for another 30 days and subjects will be randomized to receive in addition Linagliptin or Placebo for 30 days.
Subjects will come for two inhouse periods to their corresponding study center and will undergo an hyperglycaemic clamp test as well as a Meal test in each of the periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject with diabetes mellitus type 2
- •Diabetes mellitus type 2 on stable treatment with metformin (daily dose at least 1000 mg) for at least 6 months
- •HbA1c 7.0%-9.9%, both inclusive
- •Diabetes duration of at least 24 months)
排除标准
- •History of diabetes mellitus type 1
- •GFR (as calculated by the Cockcroft-Gault equation) < 60 ml/min at Screening
- •Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 95 mmHg at Screening
研究组 & 干预措施
Empagliflozin plus Linagliptin
Linagliptin 5mg to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
干预措施: Linagliptin (Drug)
Empagliflozin plus Linagliptin
Linagliptin 5mg to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
干预措施: Empagliflozin (Drug)
Empagliflozin plus Placebo
Placebo to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
干预措施: Placebo (Other)
Empagliflozin plus Placebo
Placebo to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
干预措施: Empagliflozin (Drug)
Empagliflozin
Empagliflozin 25mg will be adminstered for 30 days in T2DM patients
干预措施: Empagliflozin (Drug)
结局指标
主要结局
• Change in glucagon release (AUC0-180 min) during Liquid Meal Test (LMT) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo)
时间窗: 30 days
次要结局
- • Change in glucagon release (AUC0-180 min) during LMT from V2 to V3 during treatment with Empagliflozin (V2 vs. V3)(30 days)