None listed
Conditions
Interventions
Intervention1: Tagatose: 15gm tid for 12 months
Control Intervention1: Splenda: 1.5 gm tid for 12 months
Sponsors
Spherix Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1.Type 2 diabetics in accordance with WHO. 2.Male and female patients, >18 and 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 (±10%) for 3 months before study entry. 8.The subjects must give signed informed consent before any trial related activities
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant decrease in hemoglobin A1c (HbA1c) levelsTimepoint: 4, 6, 8, 10, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in fasting blood glucose, insulin, and lipid profiles; changes in body weight at the end of the studyTimepoint: 4, 6, 8, 10, 12 months | — |
Countries
India
Contacts
Public ContactRakesh N Dadhania
Manipal Acunova
Outcome results
None listed