AMG 151 Amgen Protocol Number 20100761

April 24, 2014 updated by: Amgen

A Randomized, Double-Blind, Placebo-Controlled Study to Explore Dose Effect and Frequency of Administration of AMG 151 in Subjects With Type 2 Diabetes Mellitus

This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 602 00
        • Research Site
      • Pardubice, Czech Republic, 530 02
        • Research Site
      • Praha 3, Czech Republic, 130 00
        • Research Site
  • Estonia
      • Tallinn, Estonia, 10128
        • Research Site
  • Poland
      • Lodz, Poland, 90-368
        • Research Site
      • Warszawa, Poland, 04-730
        • Research Site
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
        • Research Site
      • Cidra, Puerto Rico, 00739
        • Research Site
      • San Juan, Puerto Rico, 00909
        • Research Site
      • San Juan, Puerto Rico, 00917
        • Research Site
      • San Juan, Puerto Rico, 00926-2832
        • Research Site
      • San Juan, Puerto Rico, 00920
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85021
        • Research Site
      • Tucson, Arizona, United States, 85704
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Chula Vista, California, United States, 91911
        • Research Site
      • Fresno, California, United States, 93720
        • Research Site
      • Greenbrae, California, United States, 94904
        • Research Site
      • Inglewood, California, United States, 90301
        • Research Site
      • Lomita, California, United States, 90717
        • Research Site
      • Los Angeles, California, United States, 90017
        • Research Site
      • Los Angeles, California, United States, 90057
        • Research Site
      • Palm Desert, California, United States, 92260
        • Research Site
      • Roseville, California, United States, 95661
        • Research Site
      • San Diego, California, United States, 92161
        • Research Site
      • San Jose, California, United States, 95123
        • Research Site
      • Walnut Creek, California, United States, 94598
        • Research Site
      • Watsonville, California, United States, 95076
        • Research Site
    • Florida
      • Bradenton, Florida, United States, 34208
        • Research Site
      • Brooksville, Florida, United States, 34601
        • Research Site
      • Clearwater, Florida, United States, 33756
        • Research Site
      • Fort Myers, Florida, United States, 33912
        • Research Site
      • Kissimmee, Florida, United States, 34741
        • Research Site
      • Maitland, Florida, United States, 32751
        • Research Site
      • Palm Harbor, Florida, United States, 34684
        • Research Site
      • Saint Petersburg, Florida, United States, 33716
        • Research Site
      • St. Petersburg, Florida, United States, 33709
        • Research Site
      • Tampa, Florida, United States, 33606
        • Research Site
      • Winter Park, Florida, United States, 32789
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Research Site
      • Columbus, Georgia, United States, 31904
        • Research Site
      • Dunwoody, Georgia, United States, 30338
        • Research Site
      • Roswell, Georgia, United States, 30076
        • Research Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Research Site
    • Illinois
      • Chigago, Illinois, United States, 60607
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States, 63128
        • Research Site
    • Montana
      • Bozeman, Montana, United States, 59718
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Research Site
      • Las Vegas, Nevada, United States, 89117
        • Research Site
    • New York
      • Mineola, New York, United States, 11501
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Research Site
      • Shelby, North Carolina, United States, 28150
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58503
        • Research Site
      • Fargo, North Dakota, United States, 58103
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Research Site
      • Cleveland, Ohio, United States, 44122
        • Research Site
      • Dayton, Ohio, United States, 45439
        • Research Site
      • Kettering, Ohio, United States, 45429
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75247
        • Research Site
      • Dallas, Texas, United States, 75235
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • Houston, Texas, United States, 77029
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Research Site
    • Utah
      • Draper, Utah, United States, 84020
        • Research Site
      • Salt Lake City, Utah, United States, 84124
        • Research Site
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Research Site
      • Norfolk, Virginia, United States, 23510
        • Research Site
      • Richmond, Virginia, United States, 23219
        • Research Site
      • Salem, Virginia, United States, 24153
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 75 years, inclusive
  • Diagnosis of type 2 diabetes mellitus
  • HbA1c levels 7.5% to 11.0%, inclusive, at screening
  • Fasting C-peptide levels ≥ 0.2 nmol/L at screening
  • BMI ≥ 25 to < 45 kg/m2 at screening
  • Treated with metformin monotherapy for at least 3 months prior to randomization; the metformin dose must be ≥ 850 mg daily for at least 2 months immediately prior to randomization
  • If a subject is being treated for hyperlipidemia or hypertension they should be on stable medication for 30 days before randomization
  • Subject has provided informed consent.

Exclusion Criteria:

  • History of type 1 diabetes
  • History of significant weight gain or loss (> 10%) during the 4 weeks before randomization
  • Use of any weight loss medication (over the counter or prescription) within 60 days of randomization
  • Use of any oral or injectable anti-hyperglycemic medication (other than metformin) within 3 months prior to randomization
  • Use of chronic and/or continuous insulin administration for > 15 days in an outpatient setting to achieve and maintain glycemic control prior to randomization
  • Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
  • Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or currently diagnosed as having hypoglycemia unawareness
  • Evidence of active infections that can interfere with the study
  • Presence of clinically significant organ system disease that is not stabilized or may interfere with the study
  • Currently receiving immunosuppressive therapy
  • History of positive HIV, chronic hepatitis B or C, or cirrhosis
  • Have symptomatic congestive heart failure or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure or stroke in the past 6 months prior to screening.
  • History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
  • Any finding on the screening ECG that in the opinion of the investigator requires further cardiovascular evaluation
  • Poorly controlled hypertension defined as diastolic pressure > 100 mm Hg or systolic pressure > 160 mm Hg (assessed on two separate occasions during the screening period)
  • Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease-free state since treatment)
  • Use of known inhibitors or inducers of CYP3A4 are not permitted 30 days prior to randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AMG 151 - Arm 1
Drug: AMG 151
Drug: AMG 151 50 mg BID
Drug: Metformin
Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.
Drug: AMG 151
Drug: AMG 151 100 mg BID
Drug: AMG 151
Drug: AMG 151 200 mg BID
Drug: AMG 151
Drug: AMG 151 100 mg QD
Drug: AMG 151
Drug: AMG 151 200 mg QD
Drug: AMG 151
Drug: AMG 151 400 mg QD
Active Comparator: AMG 151 - Arm 2
Drug: AMG 151
Drug: AMG 151 50 mg BID
Drug: Metformin
Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.
Drug: AMG 151
Drug: AMG 151 100 mg BID
Drug: AMG 151
Drug: AMG 151 200 mg BID
Drug: AMG 151
Drug: AMG 151 100 mg QD
Drug: AMG 151
Drug: AMG 151 200 mg QD
Drug: AMG 151
Drug: AMG 151 400 mg QD
Active Comparator: AMG 151 - Arm 3
Drug: AMG 151
Drug: AMG 151 50 mg BID
Drug: Metformin
Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.
Drug: AMG 151
Drug: AMG 151 100 mg BID
Drug: AMG 151
Drug: AMG 151 200 mg BID
Drug: AMG 151
Drug: AMG 151 100 mg QD
Drug: AMG 151
Drug: AMG 151 200 mg QD
Drug: AMG 151
Drug: AMG 151 400 mg QD
Active Comparator: AMG 151 - Arm 4
Drug: AMG 151
Drug: AMG 151 50 mg BID
Drug: Metformin
Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.
Drug: AMG 151
Drug: AMG 151 100 mg BID
Drug: AMG 151
Drug: AMG 151 200 mg BID
Drug: AMG 151
Drug: AMG 151 100 mg QD
Drug: AMG 151
Drug: AMG 151 200 mg QD
Drug: AMG 151
Drug: AMG 151 400 mg QD
Active Comparator: AMG 151 - Arm 5
Drug: AMG 151
Drug: AMG 151 50 mg BID
Drug: Metformin
Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.
Drug: AMG 151
Drug: AMG 151 100 mg BID
Drug: AMG 151
Drug: AMG 151 200 mg BID
Drug: AMG 151
Drug: AMG 151 100 mg QD
Drug: AMG 151
Drug: AMG 151 200 mg QD
Drug: AMG 151
Drug: AMG 151 400 mg QD
Active Comparator: AMG 151 - Arm 6
Drug: AMG 151
Drug: AMG 151 50 mg BID
Drug: Metformin
Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.
Drug: AMG 151
Drug: AMG 151 100 mg BID
Drug: AMG 151
Drug: AMG 151 200 mg BID
Drug: AMG 151
Drug: AMG 151 100 mg QD
Drug: AMG 151
Drug: AMG 151 200 mg QD
Drug: AMG 151
Drug: AMG 151 400 mg QD
Placebo Comparator: Placebo Arm
AMG 151 Placebo Arm
Drug: Placebo
Placebo
Drug: Metformin
Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin
Time Frame: Change in fasting plasma glucose levels from baseline to Day 28
Change in fasting plasma glucose levels from baseline to Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test
Time Frame: Change in area under the curve from 0-4 hours (AUC0-4hr) glucose after a meal tolerancetest from baseline to Day 28, Change in incremental AUC0-4hr glucose after a meal tolerance test from baseline to Day 28
Change in area under the curve from 0-4 hours (AUC0-4hr) glucose after a meal tolerancetest from baseline to Day 28, Change in incremental AUC0-4hr glucose after a meal tolerance test from baseline to Day 28
Adverse events
Time Frame: Incidence of serious adverse events from signing of ICF to Day 42. Incidence of non-serious adverse events from randomization to Day 42.
Incidence of serious adverse events from signing of ICF to Day 42. Incidence of non-serious adverse events from randomization to Day 42.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 14, 2011

First Submitted That Met QC Criteria

November 1, 2011

First Posted (Estimate)

November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

May 13, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20100761

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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