A Phase 1, Double-blind, Randomized, 2-Way Crossover, Placebo-controlled Study to Investigate the Effect of AMG 151 on 24-hour Ambulatory Blood Pressure and Glucose Levels in Subjects With Type 2 Diabetes Mellitus

Amgen1 site in 1 country5 target enrollmentNovember 2012

ConditionsDiabetes Mellitus

InterventionsAMG 151 Placebo

DrugsAMG 151

Overview

Phase: Phase 1
Intervention: AMG 151
Conditions: Diabetes Mellitus
Sponsor: Amgen
Enrollment: 5
Locations: 1
Primary Endpoint: Mean 24-hour systolic blood pressure
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

January 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

AMG 151

Intervention: AMG 151

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Mean 24-hour systolic blood pressure

Time Frame: After 14 days of AMG 151 or placebo treatment

Secondary Outcomes

4-hour concentration time profile of glucose after the mixed meal tolerance test(After 13 days of AMG 151 or placebo treatment)
Plasma glucose 2 hours after time 0 of mixed meal tolerance test(After 13 days of AMG 151 or placebo treatment)
Mean 24-hour diastolic blood pressure(After 14 days of AMG 151 or placebo treatment)
Mean 24-hour heart rate(After 14 days of AMG 151 or placebo treatment)
24-hour concentration time profile of glucose level from continuous glucose monitoring(Day 1 and day 14 of each period)
Fasting plasma glucose and fructosamine(After 13 days of AMG 151 or placebo treatment)
Safety end points will include the incidence of treatment emergent adverse events.(Up to 2 Months)
Serum AMG 151 concentration(Up to 2 Months)
Safety end points will include laboratory safety tests.(Up to 2 Months.)
Safety end points will include vital signs.(Up to 2 Months)
Safety end points will include ECGs.(Up to 2 Months)