Evaluation of Continuous Glucose Monitoring as a Tool to Measure Glucoregulatory Effects of a Twice Daily Oral Insulin Secretagogue
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- 24 Hour Weighted Mean Glucose (WMG) At 2 Weeks
研究概览
简要总结
This trial will attempt to develop the use of Continuous Glucose Monitoring (CGM) as a tool for the evaluation of both new and existing pharmacological treatments for type 2 diabetes, using the twice daily administered dipeptidyl peptidase-4 (DPP4) inhibitor, vildagliptin as a probe. The primary hypothesis is that two weeks of treatment with 50 mg of oral Vildagliptin, twice daily will lead to a statistically significant decrease in 24 hour weighted-mean glucose (WMG) relative to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 2 diabetes mellitus on a clinical regimen that is metformin alone, up to a maximum of 3 gram per day, on a background of lifestyle measures, and has a Hemoglobin A1C at screening of > 7%.
- •If on antihyperglycemic therapy with both metformin and sulfonylurea with a Screening Visit/Visit 1 Hemoglobin A1C of >= 6.5% and =< 7.5%, should then discontinue sulfonylurea usage and undergo washout of sulfonylurea.
排除标准
- •History of either stroke, chronic seizures or major neurological disorder within the last 6 months.
- •Untreated hypertension with a blood pressure of > 160/95 mmHg.
- •History of neoplastic disease within the past 5 years.
- •History of hypersensitivity to vildagliptin or other DPP4 inhibitors.
- •Had major surgery, or donated or lost 1 unit (500 mL) of blood, or participated in another investigational study within 4 weeks prior to screen.
- •Used any illicit drug or abusively used alcohol within the past 3 months.
研究组 & 干预措施
Placebo → Vildagliptin
Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
干预措施: Vildagliptin (Drug)
Placebo → Vildagliptin
Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
24 Hour Weighted Mean Glucose (WMG) At 2 Weeks
时间窗: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment
The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG.
次要结局
- HbA1C At 12 Weeks(At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment)
- Hemoglobin A1C (HbA1C) At 2 Weeks(At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment)