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

Primary Purpose

Diabetes Mellitus

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Placebo

AMG 151

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Ambulatory blood pressure, Type 2 diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AMG 151

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Mean 24-hour systolic blood pressure

Secondary Outcome Measures

Mean 24-hour diastolic blood pressure

Mean 24-hour heart rate

24-hour concentration time profile of glucose level from continuous glucose monitoring

Fasting plasma glucose and fructosamine

Plasma glucose 2 hours after time 0 of mixed meal tolerance test

4-hour concentration time profile of glucose after the mixed meal tolerance test

Safety end points will include the incidence of treatment emergent adverse events.

Serum AMG 151 concentration

Safety end points will include laboratory safety tests.

Safety end points will include vital signs.

Safety end points will include ECGs.

Full Information

NCT ID

NCT01755442

First Posted

November 27, 2012

Last Updated

April 19, 2013

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01755442

Brief Title

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

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Terminated

Why Stopped

Amgen determined no further need for this study.

Study Start Date

November 2012 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus

Keywords

Ambulatory blood pressure, Type 2 diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMG 151

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.

Intervention Type

Drug

Intervention Name(s)

AMG 151

Intervention Description

Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.

Primary Outcome Measure Information:

Title

Mean 24-hour systolic blood pressure

Time Frame

After 14 days of AMG 151 or placebo treatment

Secondary Outcome Measure Information:

Title

Mean 24-hour diastolic blood pressure

Time Frame

After 14 days of AMG 151 or placebo treatment

Title

Mean 24-hour heart rate

Time Frame

After 14 days of AMG 151 or placebo treatment

Title

24-hour concentration time profile of glucose level from continuous glucose monitoring

Time Frame

Day 1 and day 14 of each period

Title

Fasting plasma glucose and fructosamine

Time Frame

After 13 days of AMG 151 or placebo treatment

Title

Plasma glucose 2 hours after time 0 of mixed meal tolerance test

Time Frame

After 13 days of AMG 151 or placebo treatment

Title

4-hour concentration time profile of glucose after the mixed meal tolerance test

Time Frame

After 13 days of AMG 151 or placebo treatment

Title

Safety end points will include the incidence of treatment emergent adverse events.

Time Frame

Up to 2 Months

Title

Serum AMG 151 concentration

Time Frame

Up to 2 Months

Title

Safety end points will include laboratory safety tests.

Time Frame

Up to 2 Months.

Title

Safety end points will include vital signs.

Time Frame

Up to 2 Months

Title

Safety end points will include ECGs.

Time Frame

Up to 2 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92161

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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