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

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:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

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

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:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

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 May 22, 2013