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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01755442
• Other study ID #: 20120189
• Status: Terminated
• Phase: Phase 1
• First received: November 27, 2012
• Last updated: April 19, 2013
• Start date: November 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

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.

Locations

Country	Name	City	State
United States	Research Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24-hour systolic blood pressure		After 14 days of AMG 151 or placebo treatment	Yes
Secondary	Mean 24-hour diastolic blood pressure		After 14 days of AMG 151 or placebo treatment	Yes
Secondary	Mean 24-hour heart rate		After 14 days of AMG 151 or placebo treatment	Yes
Secondary	24-hour concentration time profile of glucose level from continuous glucose monitoring		Day 1 and day 14 of each period	No
Secondary	Fasting plasma glucose and fructosamine		After 13 days of AMG 151 or placebo treatment	No
Secondary	Plasma glucose 2 hours after time 0 of mixed meal tolerance test		After 13 days of AMG 151 or placebo treatment	No
Secondary	4-hour concentration time profile of glucose after the mixed meal tolerance test		After 13 days of AMG 151 or placebo treatment	No
Secondary	Safety end points will include the incidence of treatment emergent adverse events.		Up to 2 Months	Yes
Secondary	Serum AMG 151 concentration		Up to 2 Months	No
Secondary	Safety end points will include laboratory safety tests.		Up to 2 Months.	Yes
Secondary	Safety end points will include vital signs.		Up to 2 Months	Yes
Secondary	Safety end points will include ECGs.		Up to 2 Months	Yes

External Links

•   AmgenTrials clinical trials website