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

Amgen

Status and phase: Terminated; Phase 1

Conditions: Diabetes Mellitus

Treatments: Other: Placebo; Drug: AMG 151

Study type: Interventional

Funder types: Industry

Identifiers

NCT01755442

20120189

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

AMG 151

Active Comparator group

Treatment:

Drug: AMG 151

Placebo

Placebo Comparator group

Treatment:

Other: Placebo