The main objectives of the current study are to establish the safety and clinical proof-of-concept of NC-503 in inadequately controlled patients with Type 2 diabetes and features of metabolic syndrome treated with either metformin, a sulfonylurea agent, or metformin in combination with a sulfonylurea agent.
Phase IIa Multi-center, randomized, double-blind, placebo-controlled and parallel-designed study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
capsules of 400 mg Dosage: 4 capsules (1600 mg) BID for 26 weeks
Dosage: 4 capsules BID for 26 weeks
Unnamed facility
Calgary, Alberta, Canada
Unnamed facility
Winnipeg, Manitoba, Canada
Unnamed facility
Etobicoke, Ontario, Canada
Change from baseline to Week 26 in HbA1c levels
Time frame: 26 weeks
Change in HbA1c levels
Time frame: 26 weeks
The rate of achieving glycemic control
Time frame: 26 weeks
Change in fasting serum glucose levels
Time frame: 26 weeks
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Unnamed facility
London, Ontario, Canada
Unnamed facility
Oakville, Ontario, Canada
Unnamed facility
Ottawa, Ontario, Canada
Unnamed facility
Ottawa, Ontario, Canada
Unnamed facility
Thornhill, Ontario, Canada
Unnamed facility
Toronto, Ontario, Canada
Unnamed facility
Toronto, Ontario, Canada
...and 11 more locations