This is a phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to evaluate the effect of AMG 151 on 24-hour ambulatory blood pressure and glucose levels in subjects with type 2 diabetes mellitus who are on a stable regimen of metformin alone, metformin and a dipeptidyl peptidase-4 inhibitor (DPP4), metformin and a thiazolidinedione (TZD), or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
5
Research Site
San Diego, California, United States
Mean 24-hour systolic blood pressure
Time frame: After 14 days of AMG 151 or placebo treatment
Mean 24-hour diastolic blood pressure
Time frame: After 14 days of AMG 151 or placebo treatment
Mean 24-hour heart rate
Time frame: After 14 days of AMG 151 or placebo treatment
24-hour concentration time profile of glucose level from continuous glucose monitoring
Time frame: Day 1 and day 14 of each period
Fasting plasma glucose and fructosamine
Time frame: After 13 days of AMG 151 or placebo treatment
Plasma glucose 2 hours after time 0 of mixed meal tolerance test
Time frame: After 13 days of AMG 151 or placebo treatment
4-hour concentration time profile of glucose after the mixed meal tolerance test
Time frame: After 13 days of AMG 151 or placebo treatment
Safety end points will include the incidence of treatment emergent adverse events.
Time frame: Up to 2 Months
Serum AMG 151 concentration
Time frame: Up to 2 Months
Safety end points will include laboratory safety tests.
Time frame: Up to 2 Months.
Safety end points will include vital signs.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 2 Months
Safety end points will include ECGs.
Time frame: Up to 2 Months