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

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ClinicalTrials.gov Identifier: NCT01755442
Recruitment Status : Terminated (Amgen determined no further need for this study.)
First Posted : December 24, 2012
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Placebo Drug: AMG 151 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : November 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Mean 24-hour systolic blood pressure [ Time Frame: After 14 days of AMG 151 or placebo treatment ]

Secondary Outcome Measures :
  1. Mean 24-hour diastolic blood pressure [ Time Frame: After 14 days of AMG 151 or placebo treatment ]
  2. Mean 24-hour heart rate [ Time Frame: After 14 days of AMG 151 or placebo treatment ]
  3. 24-hour concentration time profile of glucose level from continuous glucose monitoring [ Time Frame: Day 1 and day 14 of each period ]
  4. Fasting plasma glucose and fructosamine [ Time Frame: After 13 days of AMG 151 or placebo treatment ]
  5. Plasma glucose 2 hours after time 0 of mixed meal tolerance test [ Time Frame: After 13 days of AMG 151 or placebo treatment ]
  6. 4-hour concentration time profile of glucose after the mixed meal tolerance test [ Time Frame: After 13 days of AMG 151 or placebo treatment ]
  7. Safety end points will include the incidence of treatment emergent adverse events. [ Time Frame: Up to 2 Months ]
  8. Serum AMG 151 concentration [ Time Frame: Up to 2 Months ]
  9. Safety end points will include laboratory safety tests. [ Time Frame: Up to 2 Months. ]
  10. Safety end points will include vital signs. [ Time Frame: Up to 2 Months ]
  11. Safety end points will include ECGs. [ Time Frame: Up to 2 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755442


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

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01755442     History of Changes
Other Study ID Numbers: 20120189
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: April 22, 2013
Last Verified: April 2013

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