Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
236 participants
INTERVENTIONAL
2011-09-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AMG 151 - Arm 1
AMG 151 - Arm 1
AMG 151
Drug: AMG 151 50 mg BID
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.
AMG 151 - Arm 2
AMG 151 - Arm 2
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.
AMG 151
Drug: AMG 151 100 mg BID
AMG 151 - Arm 3
AMG 151 - Arm 3
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.
AMG 151
Drug: AMG 151 200 mg BID
AMG 151 - Arm 4
AMG 151 - Arm 4
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.
AMG 151
Drug: AMG 151 100 mg QD
AMG 151 - Arm 5
AMG 151 - Arm 5
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.
AMG 151
Drug: AMG 151 200 mg QD
AMG 151 - Arm 6
AMG 151 - Arm 6
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.
AMG 151
Drug: AMG 151 400 mg QD
Placebo Arm
AMG 151 Placebo Arm
Placebo
Placebo
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.
Interventions
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AMG 151
Drug: AMG 151 50 mg BID
Placebo
Placebo
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.
AMG 151
Drug: AMG 151 100 mg BID
AMG 151
Drug: AMG 151 200 mg BID
AMG 151
Drug: AMG 151 100 mg QD
AMG 151
Drug: AMG 151 200 mg QD
AMG 151
Drug: AMG 151 400 mg QD
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Chula Vista, California, United States
Research Site
Fresno, California, United States
Research Site
Greenbrae, California, United States
Research Site
Inglewood, California, United States
Research Site
Lomita, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Palm Desert, California, United States
Research Site
Roseville, California, United States
Research Site
San Diego, California, United States
Research Site
San Jose, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Watsonville, California, United States
Research Site
Bradenton, Florida, United States
Research Site
Brooksville, Florida, United States
Research Site
Clearwater, Florida, United States
Research Site
Fort Myers, Florida, United States
Research Site
Kissimmee, Florida, United States
Research Site
Maitland, Florida, United States
Research Site
Palm Harbor, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
St. Petersburg, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Winter Park, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Columbus, Georgia, United States
Research Site
Dunwoody, Georgia, United States
Research Site
Roswell, Georgia, United States
Research Site
Meridian, Idaho, United States
Research Site
Chigago, Illinois, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Metairie, Louisiana, United States
Research Site
Bethesda, Maryland, United States
Research Site
St Louis, Missouri, United States
Research Site
Bozeman, Montana, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Mineola, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Shelby, North Carolina, United States
Research Site
Bismarck, North Dakota, United States
Research Site
Fargo, North Dakota, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Kettering, Ohio, United States
Research Site
Norman, Oklahoma, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Dallas, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Draper, Utah, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Midlothian, Virginia, United States
Research Site
Norfolk, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Salem, Virginia, United States
Research Site
Brno, , Czechia
Research Site
Pardubice, , Czechia
Research Site
Prague, , Czechia
Research Site
Tallinn, , Estonia
Research Site
Lodz, , Poland
Research Site
Warsaw, , Poland
Research Site
Carolina, , Puerto Rico
Research Site
Cidra, , Puerto Rico
Research Site
San Juan, , Puerto Rico
Research Site
San Juan, , Puerto Rico
Research Site
San Juan, , Puerto Rico
Research Site
San Juan, , Puerto Rico
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20100761
Identifier Type: -
Identifier Source: org_study_id
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