Clinical trial NCT01755442: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: Ambulatory blood pressure
Type 2 diabetes
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-12-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean 24-hour systolic blood pressure
timeFrame: After 14 days of AMG 151 or placebo treatment
Secondary outcomes:
measure: Mean 24-hour diastolic blood pressure
timeFrame: After 14 days of AMG 151 or placebo treatment
measure: Mean 24-hour heart rate
timeFrame: After 14 days of AMG 151 or placebo treatment
measure: 24-hour concentration time profile of glucose level from continuous glucose monitoring
timeFrame: Day 1 and day 14 of each period
measure: Fasting plasma glucose and fructosamine
timeFrame: After 13 days of AMG 151 or placebo treatment
measure: Plasma glucose 2 hours after time 0 of mixed meal tolerance test
timeFrame: After 13 days of AMG 151 or placebo treatment
measure: 4-hour concentration time profile of glucose after the mixed meal tolerance test
timeFrame: After 13 days of AMG 151 or placebo treatment
measure: Safety end points will include the incidence of treatment emergent adverse events.
timeFrame: Up to 2 Months
measure: Serum AMG 151 concentration
timeFrame: Up to 2 Months
measure: Safety end points will include laboratory safety tests.
timeFrame: Up to 2 Months.
measure: Safety end points will include vital signs.
timeFrame: Up to 2 Months
measure: Safety end points will include ECGs.
timeFrame: Up to 2 Months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Research Site
state: California
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: