This trial is a multi-center, adaptive, randomized, double-blind, placebo- and active- controlled, parallel group, Phase 2 study in subjects with T2DM to evaluate the effect of TTP399 on HbA1c following administration for 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
190
Unnamed facility
Mesa, Arizona, United States
Unnamed facility
Tuscon, Arizona, United States
Change in HbA1c (Glycosylated haemoglobin)
Time frame: Day 1 to Day 168
HbA1c < 7% at 6 months
Time frame: Day 1 to Day 168
HbA1c < 6.5% at 6 months
Time frame: Day 1 to Day 168
Plasma Glucose Levels
Time frame: Day 1 to Day 168
Lipid Levels
Time frame: Day 1 to Day 168
Insulin Levels
Time frame: Day 1 to Day 168
Lactate Levels
Time frame: Day 1 to Day 168
C-peptide Levels
Time frame: Day 1 to Day 168
Glucagon Levels
Time frame: Day 1 to Day 168
Glucagon-like Peptide-1 Levels
Time frame: Day 1 to Day 168
Change in Body Weight
Time frame: Day 1 to Day 168
Adverse Events
Time frame: Day 1 to Day 182
Blood Pressure
Time frame: Day 1 to Day 182
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once daily
Unnamed facility
Canoga Park, California, United States
Unnamed facility
Huntington Park, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
West Hills, California, United States
Unnamed facility
Centennial, Colorado, United States
Unnamed facility
Littleton, Colorado, United States
Unnamed facility
Waterbury, Connecticut, United States
Unnamed facility
West Palm Beach, Florida, United States
...and 10 more locations
Electrocardiogram Parameters
Time frame: Day 1 to Day 182
Hematology
Time frame: Day 1 to Day 182
Blood Chemistry
Time frame: Day 1 to Day 182
Urinalysis
Time frame: Day 1 to Day 182
Pulse
Time frame: Day 1 to Day 182