Terminated/Withdrawn
Sponsor ID
20120189

Investigate Effect of AMG 151 on 24-hour Ambulatory Blood Pressure & Glucose Levels in Type 2 Diabetes Mellitus Subjects

Sponsor ID
20120189
Clinicaltrials.gov ID
NCT01755442
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 151
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
5
Additional Study Details

Protocol Summary

Primary Outcome Measures

Mean 24-hour systolic blood pressure

Timeframe: After 14 days of AMG 151 or placebo treatment

Secondary Outcome Measures

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

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
San Diego, CA, United States, 92161
Status
Recruiting