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

• ClinicalTrials.gov Identifier: NCT01755442
• Recruitment Status: Terminated
• First Posted: December 24, 2012
• Last Update Posted: April 22, 2013
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: November 27, 2012
• First Posted Date: December 24, 2012
• Last Update Posted Date: April 22, 2013
• Study Start Date: November 2012
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Investigate Effect of AMG 151 on 24-hour Ambulatory Blood Pressure & Glucose Levels in Type 2 Diabetes Mellitus Subjects
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Diabetes Mellitus

Intervention

• 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

• Active Comparator: AMG 151
  Intervention: Drug: AMG 151
• Placebo Comparator: Placebo
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 19, 2013): 5
• Original Estimated Enrollment (submitted: December 19, 2012): 26
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01755442
• Other Study ID Numbers: 20120189
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Amgen
• Study Sponsor: Amgen
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: April 2013