Status and phase
Conditions
Treatments
About
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:
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:
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).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Subjects who have any DM-related end-organ damages.
Subjects who have a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
Subjects who have any disease likely to limit life span and/or increase risks of interventions such as:
Subjects who have any of the following conditions related to cardiovascular disease:
Subjects who have any of the following conditions related to gastrointestinal disease:
Subjects who have serum creatinine > 1.5 mg/dL for male or > 1.4 mg/dL for female.
Subjects who have chronic obstructive airway disease or asthma requiring daily therapy or home use oxygen.
Subjects who have hematocrit < 36.0% for male or < 33.0% for female.
Subjects who have any of the following conditions or behaviors likely to affect the conduct of the study:
Subjects who take any of the following medications:
Female subjects who have a positive serum pregnancy test at Screening, plan a pregnancy during study period, or are breast feeding.
Female subjects who don't meet any of the following criteria:
Primary purpose
Allocation
Interventional model
Masking
64 participants in 4 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal