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A Clinical Study to Evaluate the Effect of Naturlose (Tagatose) - NCT00961662-77036(Clinical Trial 306385)



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City:  Houston
State:  
TX
Zip Code: 77036
Conditions: Type 2 Diabetes
Purpose: 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 will be randomized in one of the 3 arms receiving 2.5, 5 or 7.5 gm of Tagatose. This trial is already on-going in the USA, and is intended to be conducted at 25 investigational sites globally, including 8 sites in India.
Study summary:
Criteria: Inclusion Criteria: - 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 Exclusion Criteria: - 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.
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Data Source: ClinicalTrials.gov
Date Processed: May 11, 2010
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