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

This study has been terminated.
(Amgen determined no further need for this study.)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01755442
First received: November 27, 2012
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Other: Placebo
Drug: AMG 151
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Mean 24-hour systolic blood pressure [ Time Frame: After 14 days of AMG 151 or placebo treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean 24-hour diastolic blood pressure [ Time Frame: After 14 days of AMG 151 or placebo treatment ] [ Designated as safety issue: Yes ]
  • Mean 24-hour heart rate [ Time Frame: After 14 days of AMG 151 or placebo treatment ] [ Designated as safety issue: Yes ]
  • 24-hour concentration time profile of glucose level from continuous glucose monitoring [ Time Frame: Day 1 and day 14 of each period ] [ Designated as safety issue: No ]
  • Fasting plasma glucose and fructosamine [ Time Frame: After 13 days of AMG 151 or placebo treatment ] [ Designated as safety issue: No ]
  • Plasma glucose 2 hours after time 0 of mixed meal tolerance test [ Time Frame: After 13 days of AMG 151 or placebo treatment ] [ Designated as safety issue: No ]
  • 4-hour concentration time profile of glucose after the mixed meal tolerance test [ Time Frame: After 13 days of AMG 151 or placebo treatment ] [ Designated as safety issue: No ]
  • Safety end points will include the incidence of treatment emergent adverse events. [ Time Frame: Up to 2 Months ] [ Designated as safety issue: Yes ]
  • Serum AMG 151 concentration [ Time Frame: Up to 2 Months ] [ Designated as safety issue: No ]
  • Safety end points will include laboratory safety tests. [ Time Frame: Up to 2 Months. ] [ Designated as safety issue: Yes ]
  • Safety end points will include vital signs. [ Time Frame: Up to 2 Months ] [ Designated as safety issue: Yes ]
  • Safety end points will include ECGs. [ Time Frame: Up to 2 Months ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: November 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755442

Locations
United States, California
Research Site
San Diego, California, United States, 92161
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01755442     History of Changes
Other Study ID Numbers: 20120189
Study First Received: November 27, 2012
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Ambulatory blood pressure
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014