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



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:3/30/2013
Start Date:November 2012
End Date:May 2013
Contact:Amgen Call Center
Phone:866-572-6436

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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


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.


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
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