NCT01755442

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1 diabetes-mellitus

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_1 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

2 months

First QC Date

November 27, 2012

Last Update Submit

April 19, 2013

Conditions

Diabetes Mellitus

Keywords

Ambulatory blood pressureType 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Mean 24-hour systolic blood pressure

    After 14 days of AMG 151 or placebo treatment

Secondary Outcomes (11)

  • 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

  • Plasma glucose 2 hours after time 0 of mixed meal tolerance test

    After 13 days of AMG 151 or placebo treatment

  • +6 more secondary outcomes

Study Arms (2)

AMG 151

ACTIVE COMPARATOR
Drug: AMG 151

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

PlaceboOTHER

Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.

Placebo
AMG 151DRUG

Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.

AMG 151

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with type 2 diabetes mellitus
  • On a stable regimen of metformin alone, metformin and a DPP4, metformin and a TZD, or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization
  • Body mass indices \> 25 and \< 45 kg/m2
  • Hemoglobin A1c levels ≥ 7.0% and ≤ 11.0% at screening
  • Fasting C-peptide levels ≥ 0.2 nmol/L at screening
  • Subject with a history of hypertension must be on a stable antihypertensive treatment (s) (type of medication, dose, and regimen) for at least 6 weeks prior to the first dose of investigational product
  • Other criteria may apply

You may not qualify if:

  • Subject has type 1 diabetes mellitus or history of type 1 diabetes mellitus
  • Subject has had 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening
  • Poorly controlled hypertension defined as diastolic pressure ≥ 95 mmHg or systolic ≥ 155 mmHg (confirmed by a repeat assessment) at screening
  • Triglycerides ≥ 400 mg/dL (4.52 mmol/L) at screening
  • Use of any known cytochrome P450 (CYP) inducers within 30 days or 5 half-lives (whichever is longer), prior to receiving the first dose of investigational product.
  • Use of any known inhibitors of CYP3A4/P-glycoprotein within the 14 days or 5 half lives (whichever is longer) prior to receiving the first dose of investigational product
  • Other criteria may apply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

San Diego, California, 92161, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 24, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 22, 2013

Record last verified: 2013-04

Locations

US(1)