A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess Efficacy, Safety and Tolerability of Sitagliptin Phosphate 100 mg as Treatment for Recurrent, Persistent or Newly Diagnosed Type 2 Diabetes After Gastric Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in Postprandial Glucose Levels After Mixed Meal Test
研究概览
简要总结
The purpose of this study is to assess whether Januvia (sitagliptin phosphate 100mg) is safe and effective for the treatment of Type 2 Diabetes in patients who have had Gastric Bypass.
详细描述
Januvia (sitagliptin phosphate 100mg) is an FDA approved medication for the treatment of Type 2 Diabetes. Sitagliptin works by inhibiting the Dipeptidyl peptidase-4 enzyme, resulting in increased active glucagon-like peptide-1 (GLP-1) levels. GLP-1 is an incretin which increases post-prandial insulin secretion. Because Gastric Bypass has also been shown to increase GLP-1 levels, this study seeks to determine the additional effect of DDP-4 inhibition on glucose control in patients who have elevated incretin levels post Gastric Bypass. The study will also assess if Januvia (Sitagliptin phosphate) is safe and well tolerated in patients after Gastric Bypass.
Recruitment and data collection for this study was started at St. Luke's Hospital in New York, NY and later moved to Columbia University Medical Center in New York, NY.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be a resident of the NYC metropolitan area or be able to come for emergency unscheduled and regular weekly meetings in Manhattan.
- •HbA1c ≥ 6.5% and ≤ 8.5 % or a fasting glucose ≥ 126 mg/dL or a random glucose ≥ 200 mg/dL at least 12 months after GBP surgery confirmed by central laboratory.
- •Subject is capable and willing to give informed consent.
- •Subject is otherwise in good general health, based on medical history and physical examination.
- •Subject is a non smoker for at least 6 months prior to study start
- •Female subjects of child bearing potential must use oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the first administration of the challenge agent. Subjects using hormonal contraception should use a barrier method in addition from the first administration of challenge agent until their next normal period following the end of the study.
排除标准
- •History of type 1 diabetes
- •Female subject is pregnant or breastfeeding.
- •Recent (< 30 days) or simultaneous participation in another clinical trial.
- •Any situation that can compromise the study, including serious illness or a predictable lack of cooperation from the subject.
研究组 & 干预措施
Sitagliptin phosphate
100 mg/day sitagliptin phosphate (Januvia) PO once a day for 4-5 weeks
干预措施: Sitagliptin phosphate (Drug)
Placebo
1 Placebo pill / day PO once a day for 4-5 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change in Postprandial Glucose Levels After Mixed Meal Test
时间窗: Baseline and ~4 weeks
Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo).
Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test
时间窗: Baseline and ~4 weeks
Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo). AUC was measured by trapezoidal method.
次要结局
- Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery(Baseline and ~4 weeks)
- Occurrence of Side Effects In Relation to Sitagliptin(6 weeks)
- Active GLP-1(Pre-Intervention and Post-Intervention)
研究者
Blandine Laferrere
Associate Professor of Medicine, Columbia University
Columbia University