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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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