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

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

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 Overview

• Status: Terminated
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: AMG 151; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.
Active Comparator: AMG 151	Drug: AMG 151; Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean 24-hour systolic blood pressure	After 14 days of AMG 151 or placebo treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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
4-hour concentration time profile of glucose after the mixed meal tolerance test	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

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: December 19, 2012
• First Posted (Estimate): December 24, 2012

Study Record Updates

• Last Update Posted (Estimate): April 22, 2013
• Last Update Submitted That Met QC Criteria: April 19, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Ambulatory blood pressure
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20120189