This trial is designed to show the effect of treatment with TT223 or placebo on blood glucose control after 12 weeks of treatment with a 6 month follow-up. TT223 is administered by injection once daily to patients currently treated with Metformin and/or Thiazolidinedione.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
87
Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
Daily subcutaneous injection: 1 mg for 1 week; followed by 2 mg for 1 week; followed by 3 mg for 10 weeks
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Artesia, California, United States
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Los Angeles, California, United States
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Santa Ana, California, United States
To evaluate the safety and tolerability of TT223 as a treatment for Type 2 diabetes at 1 mg, 2 mg and 3 mg.
Time frame: For the duration of the trial.
To evaluate the efficacy of TT223 as a treatment for Type 2 diabetes by comparing the change in HbA1c value from baseline between the TT223 and placebo groups.
Time frame: For the duration of the trial.
To evaluate the efficacy of TT223 on beta cell function by assessing additional outcome measures including fasting blood glucose levels, and meal tolerance testing.
Time frame: For the duration of the trial.
To determine the pharmacokinetic (PK) parameter profile of TT223 in a subset of patients.
Time frame: Day 1 and Week 12 of treatment.
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Unnamed facility
Torrence, California, United States
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Walnut Creek, California, United States
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DeLand, Florida, United States
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Bloomingdale, Illinois, United States
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Grand Rapids, Michigan, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
...and 10 more locations