Multicenter, Open, Pragmatic, Randomized Trial Comparing the Efficacy of 3 Different Lifestyle Interventions After Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,512
- 主要终点
- Hemoglobin A1c Measurement
研究概览
简要总结
To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled by metformin (hemoglobin A1c [HbA1c] 6.5-9%). A difference between the three strategies of lifestyle changes was expected.
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
- None
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
- •Man or woman aged >/= 18 years,with T2DM and treated with the maximal tolerated dose of metformin, with documented or high likely inadequate control of diabetes (HbA1c 6.5-9%)
排除标准
- •Daily insulin treatment or one insulin dose or more within the last 8 weeks or expected insulin treatment within the next 3 months.
- •Hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis
- •Known hypersensitivity or contraindication to metformin
研究组 & 干预措施
Sitagliptin with Standard of Care
Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet.
干预措施: sitagliptin phosphate (Drug)
Sitagliptin with Diet Advice
Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
Intervention on diet which includes advice on diet with a leaflet and a diary
干预措施: sitagliptin phosphate (Drug)
Sitagliptin with Diet and Physical Activity Advice
Subjects received sitagliptin 100 mg once daily for 26 Weeks,
and:
Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.
干预措施: sitagliptin phosphate (Drug)
结局指标
主要结局
Hemoglobin A1c Measurement
时间窗: Baseline and Week 24
Hemoglobin A1c (HbA1c) is a measure of glycated hemoglobin in the blood. HbA1c greater than 6.5% was considered inadequately controlled.
次要结局
- Fasting Plasma Glucose (FPG) Measurement(Baseline and Week 24)