Dose Ranging Effects of Three Low-doses of Naturlose™ (Tagatose) on Glycemic Control and Safety of Naturlose™ (Tagatose) Over Six Months in Subjects With Mild Type 2 Diabetes Mellitus Under Control With Diet and Exercise.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 13
- 主要终点
- Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus
研究概览
简要总结
This study is a six-month, prospective, randomized, multicenter, single- blind, controlled clinical study to evaluate the effect of three low-doses of Naturlose (Tagatose) on glycemic control and safety in subjects with Type 2 diabetes under diet control and exercise. The subjects were randomized in one of the 3 arms receiving 2.5, 5 or 7.5 gm of Tagatose.
详细描述
Screening (Visit 1) and Run-in Period
This period of the study was designed as an 8-week screening and stabilization period, during which potentially eligible subjects participated in a weight-maintaining diet and a daily exercise program.
Subjects who were eligible for screening were diabetic subjects treated solely with diet and exercise and who had mildly elevated HbA1c levels but were otherwise in good health and were not suffering from any serious complications of diabetes.
At the end of the screening visit, potentially eligible study subjects were instructed to follow a weight-maintaining diet and a daily exercise program. They were given a blank subject diary and a nutritional diary, and were scheduled for the second visit (Visit 2) after 8 weeks of stabilization.
Randomization Visit (Visit 2)
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetics in accordance with WHO.
- •Male and female patients, between 18 and 75 years of age.
- •Diabetic patients who are not on medication for the disease. Patients may be treated with diet and exercise.
- •Normal blood creatine clearance and normal liver function test results.
- •BMI less than or equal to 45 kg/m2
排除标准
- •Treatment with sulfonylurea (e.g., Glyburide, Glipizide, Glimepiride, Chlorpropamide, Tolazamide, Acetohexamide, or Tolbutamide), TZDs, metformin, acarbose, Byetta, insulin, and any antidiabetic medications within the prior 3 months.
- •Therapy with beta-blockers or thiazide diuretics within the prior 3 months
- •Pregnancy, breastfeeding, or intention of becoming pregnant or judged to be using inadequate contraceptive measure.
- •Documented gastrointestinal disease, or taking of medications likely to alter gut motility or absorption.
- •Receiving any investigational drug within 30 days of the baseline visit.
研究组 & 干预措施
2.5 active
2.5 Active - 2.5 g D-tagatose given orally, three times daily, immediately prior to meals for 6 months.
干预措施: D-Tagatose (Drug)
5.0 mid dose
5.0 mid dose - 5.0 g D-tagatose given orally, three times daily, immediately prior to meals for 6 months.
干预措施: D-Tagatose (Drug)
7.5 high dose
7.5 high dose - 7.5 g D-tagatose given orally, three times daily, immediately prior to meals for 6 months.
干预措施: D-Tagatose (Drug)
结局指标
主要结局
Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus
时间窗: 6 months from baseline
The primary efficacy parameter was a dichotomous variable: the treatment success as measured by a reduction from baseline HbA1c by at least 0.5 units after six months of treatment (i.e.,0.5% reduction in HbA1c after six months of treatment).
次要结局
- A Decrease of Fasting Plasma Glucose (FPG) Level Compared With Baseline Level at Any Time Point Over the Duration of the Study(6 months)
- Body Weight Loss (Compared to Baseline)(6 months)
- A Decrease of ≥0.5% in HbA1c Level at Each Study Visit(6 months)
- Effects of Naturlose (Tagatose) on Other Glycemic Control Measurements Such as Plasma Glucose Concentrations and Plasma Lipids at Each Study Visit(6 months)
- A Decrease of ≥1% in HbA1c Level in Any of the Naturlose (Tagatose) Treatment Groups at Any Time Point Over the Duration of the Study(8 months)
研究者
Robert Lodder
PhD
Spherix Incorporated