Diabetes Mellitus
Conditions
Keywords
Ambulatory blood pressure, Type 2 diabetes
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.
Interventions
OTHERPlacebo
Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.
DRUGAMG 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.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean 24-hour systolic blood pressure | After 14 days of AMG 151 or placebo treatment |
Secondary
| Measure | Time frame |
|---|---|
| Mean 24-hour heart rate | After 14 days of AMG 151 or placebo treatment |
| 24-hour concentration time profile of glucose level from continuous glucose monitoring | Day 1 and day 14 of each period |
| Fasting plasma glucose and fructosamine | After 13 days of AMG 151 or placebo treatment |
| Plasma glucose 2 hours after time 0 of mixed meal tolerance test | After 13 days of AMG 151 or placebo treatment |
| 4-hour concentration time profile of glucose after the mixed meal tolerance test | After 13 days of AMG 151 or placebo treatment |
| Mean 24-hour diastolic blood pressure | After 14 days of AMG 151 or placebo treatment |
| Serum AMG 151 concentration | Up to 2 Months |
| Safety end points will include laboratory safety tests. | Up to 2 Months. |
| Safety end points will include vital signs. | Up to 2 Months |
| Safety end points will include ECGs. | Up to 2 Months |
| Safety end points will include the incidence of treatment emergent adverse events. | Up to 2 Months |
Countries
United States
Outcome results
None listed