Effects of Naturlose (Tagatose) on Glycemic Control and Safety of Naturlose Over One Year in Subjects With Type 2 Diabetes Under Diet Control and Exercise
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 494
- 试验地点
- 45
- 主要终点
- Change in Hemoglobin A1C Level From Baseline
研究概览
简要总结
The purpose of this trial was to evaluate the effectiveness and safety of Naturlose (Tagatose) for glycemic control in people with Type 2 diabetes who were not taking other medications for the condition and who were under diet control and exercise.
The study lasted approximately one year. HbA1c was monitored every 2 months after entry into the study. Safety and tolerance for tagatose were assessed every 2 months throughout the study. A total of 14 visits were made to the study site.
详细描述
This was a Phase 3, prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy, safety, and tolerability of D-tagatose (as compared to placebo). Prior to the start of treatment, subjects participated in an 8-week run-in period during which diabetes education was provided and diet and exercise treatment stabilized. Efficacy analyses were conducted on data from 4 and 6 months.
Screening Visit
Based on the inclusion and exclusion criteria, eligible subjects underwent a basic physical examination, pregnancy test for females, and hematology, clinical chemistry, and urinalysis tests. Basic physical examination included physical measurements, general examination by observation, palpation, percussion, auscultation, blood pressure measure, and heart rate check. The clinical laboratory tests included: 1) hematology (hematocrit, hemoglobin, MCH, MCHC, MCV, total white blood cells, platelets, and differential); 2) clinical chemistry (sodium, chloride, potassium, CO2, BUN, uric acid, albumin, creatinine clearance, SGOT, SGPT, bilirubin (total and direct), phosphorus, calcium, alkaline phosphatase, total protein, and glucose (fasting); 3) HbA1c; 4) serum lipid profile including total cholesterol, HDL, LDL, and triglycerides; 5) urinalysis (appearance, volume, specific gravity, pH, glucose, protein, and microscopic evaluation of urinary sediment).
Run-in Period
Subjects deemed potentially eligible on the basis of their medical records were to continue on their previously established diet and exercise treatment program under physician's recommendation for 8 weeks. Patients were to record their food intake and exercise in nutrition diaries.
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 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 45kg/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
Sugar Substitute Splenda
1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
干预措施: Sugar Substitute Splenda (Drug)
Tagatose
15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
干预措施: Tagatose (Drug)
结局指标
主要结局
Change in Hemoglobin A1C Level From Baseline
时间窗: 1 year from baseline
The primary efficacy variable will be the change in HbA1c level from baseline. Changes from baseline in HbA1c level at each visit will be assessed with the use of linear model(ANCOVA) to adjust for any baseline difference, as well as the stratification factor.
次要结局
未报告次要终点
研究者
Robert Lodder
Professor
Spherix Incorporated