Diabetes Mellitus Type 2 in Obese Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Cyclo-Z in Patients With Obese Type 2 Diabetes
This is a double-blind, randomized, placebo-controlled, parallel-group comparison study to
evaluate the efficacy and safety of Cyclo-Z for the treatment of subjects with obese type 2
diabetes.
The study will consist of 3 phases:
- Screening phase (2 weeks)
- Treatment phase (12 weeks)
- Follow-up phase (2 weeks)
Following a 2-week screening period, subjects who meet all inclusion and exclusion criteria
will be randomly assigned into one of the following treatment arms:
- Dose A: Cyclo-Z containing 23 mg zinc plus 3 mg CHP - 16 subjects
- Dose B: Cyclo-Z containing 23 mg zinc plus 9 mg CHP - 16 subjects
- Dose C: Cyclo-Z containing 23 mg zinc plus 15 mg CHP - 16 subjects
- Dose D: Placebo - 16 subjects
The assigned dose will be orally administered to subjects once a day before bedtime for 12
consecutive weeks. After the randomization at Week 0 (Visit 2), subjects will visit their
respective trial sites at Weeks 2, 4, 6, 8, 10, 12, and 14 (Visits 3, 4, 5, 6, 7, 8, and 9).
n/a
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