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

NCT ID: NCT01755442

Last Updated: 2013-04-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-01-31

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AMG 151

Group Type: ACTIVE_COMPARATOR

AMG 151

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Research Site

San Diego, California, United States

Countries

United States

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20120189

Identifier Type: -

Identifier Source: org_study_id