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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

Tracking Information
First Submitted Date  ICMJE November 27, 2012
First Posted Date  ICMJE December 24, 2012
Last Update Posted Date April 22, 2013
Study Start Date  ICMJE November 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
Mean 24-hour systolic blood pressure [ Time Frame: After 14 days of AMG 151 or placebo treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
  • Mean 24-hour diastolic blood pressure [ Time Frame: After 14 days of AMG 151 or placebo treatment ]
  • Mean 24-hour heart rate [ Time Frame: After 14 days of AMG 151 or placebo treatment ]
  • 24-hour concentration time profile of glucose level from continuous glucose monitoring [ Time Frame: Day 1 and day 14 of each period ]
  • Fasting plasma glucose and fructosamine [ Time Frame: After 13 days of AMG 151 or placebo treatment ]
  • Plasma glucose 2 hours after time 0 of mixed meal tolerance test [ Time Frame: After 13 days of AMG 151 or placebo treatment ]
  • 4-hour concentration time profile of glucose after the mixed meal tolerance test [ Time Frame: After 13 days of AMG 151 or placebo treatment ]
  • Safety end points will include the incidence of treatment emergent adverse events. [ Time Frame: Up to 2 Months ]
  • Serum AMG 151 concentration [ Time Frame: Up to 2 Months ]
  • Safety end points will include laboratory safety tests. [ Time Frame: Up to 2 Months. ]
  • Safety end points will include vital signs. [ Time Frame: Up to 2 Months ]
  • Safety end points will include ECGs. [ Time Frame: Up to 2 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigate Effect of AMG 151 on 24-hour Ambulatory Blood Pressure & Glucose Levels in Type 2 Diabetes Mellitus Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: AMG 151
    Intervention: Drug: AMG 151
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 19, 2013)
5
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2012)
26
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755442
Other Study ID Numbers  ICMJE 20120189
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP