Effects of Naturlose (Tagatose) on blood sugar Control and Safety of Naturlose Over One Year in Subjects with Type 2 Diabetes under Diet Control and Exercise

Spherix Inc0 个研究点目标入组 550 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Type 2 diabetics in accordance with WHO.
•2.Male and female patients, >18 and <75 years of age.
•3.Diabetic patients who are not on medication for the disease. Patients may be treated with diet and exercise.
•4.HbA1c level at screening and baseline greater than 6.6% and less than 9.0%.
•5.Fasting glucose concentration less than 240 mg/dL (13.3 mmol/l).
•6.BMI must be less than or equal to 45 kg/m2.
•7.Weight stable (Â±10%) for 3 months before study entry.
•8.The subjects must give signed informed consent before any trial related activities

•1.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.
•2.Chronic (lasting longer than 14 consecutive days) systemic glucocorticoid treatment (excludes topical and inhaled forms) or have received such treatment within 4 weeks of the baseline visit.
•3.Any weight loss drugs within the prior 3 months.
•4.Proliferative retinopathy.
•5.Known or suspected abuse of alcohol or narcotics.
•6.Hypoglycemic unconsciousness.
•7.Impaired hepatic function (SGOT and SGPT 2 times normal range).
•8.Impaired renal function (Se-creatinine 132 mM, or 1.5 mg/dL).
•9.Cardiac problems defined as: Decompensated heart failure (NYHA class III or IV); unstable angina pectoris; Myocardial infarction within the last 12 months.
•10.Uncontrolled hypertension (systolic pressure 180 mm Hg and/or diastolic pressure 100 mm Hg).
•11.Pregnancy, breastfeeding, or intention of becoming pregnant or judged to be using inadequate contraceptive measure.
•12.Documented gastrointestinal disease, or taking of medications to alter gut motility or absorption.
•13.Receiving any investigational drug within 30 days of the screening visit.
•14.Patients who are deemed inadequate for the trials by principal investigators.

发起方

Spherix Inc