Investigate Effect of AMG 151 on 24-hour Ambulatory Blood Pressure & Glucose Levels in Type 2 Diabetes Mellitus Subjects
Study Details
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.
Protocol Summary
Mean 24-hour systolic blood pressure
Timeframe: After 14 days of AMG 151 or placebo treatment
Mean 24-hour diastolic blood pressure
Timeframe: After 14 days of AMG 151 or placebo treatment
Mean 24-hour heart rate
Timeframe: After 14 days of AMG 151 or placebo treatment
24-hour concentration time profile of glucose level from continuous glucose monitoring
Timeframe: Day 1 and day 14 of each period
Fasting plasma glucose and fructosamine
Timeframe: After 13 days of AMG 151 or placebo treatment
Plasma glucose 2 hours after time 0 of mixed meal tolerance test
Timeframe: After 13 days of AMG 151 or placebo treatment
4-hour concentration time profile of glucose after the mixed meal tolerance test
Timeframe: After 13 days of AMG 151 or placebo treatment
Safety end points will include the incidence of treatment emergent adverse events.
Timeframe: Up to 2 Months
Serum AMG 151 concentration
Timeframe: Up to 2 Months
Safety end points will include laboratory safety tests.
Timeframe: Up to 2 Months.
Safety end points will include vital signs.
Timeframe: Up to 2 Months
Safety end points will include ECGs.
Timeframe: Up to 2 Months