Clinical trial NCT01464437: AMG 151 Amgen Protocol Number 20100761
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Keywords: diabetes
mellitus
metformin
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2011-11-03
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Change in fasting plasma glucose levels from baseline to Day 28
Secondary outcomes:
measure: To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test
timeFrame: 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
measure: Adverse events
timeFrame: Incidence of serious adverse events from signing of ICF to Day 42. Incidence of non-serious adverse events from randomization to Day 42.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Fresno
country: United States
facility: Research Site
state: California
city: Greenbrae
country: United States
facility: Research Site
state: California
city: Inglewood
country: United States
facility: Research Site
state: California
city: Lomita
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Palm Desert
country: United States
facility: Research Site
state: California
city: Roseville
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Jose
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Watsonville
country: United States
facility: Research Site
state: California
city: Bradenton
country: United States
facility: Research Site
state: Florida
city: Brooksville
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
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state: Florida
city: Fort Myers
country: United States
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state: Florida
city: Kissimmee
country: United States
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state: Florida
city: Maitland
country: United States
facility: Research Site
state: Florida
city: Palm Harbor
country: United States
facility: Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Research Site
state: Florida
city: St. Petersburg
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Columbus
country: United States
facility: Research Site
state: Georgia
city: Dunwoody
country: United States
facility: Research Site
state: Georgia
city: Roswell
country: United States
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state: Georgia
city: Meridian
country: United States
facility: Research Site
state: Idaho
city: Chigago
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Metairie
country: United States
facility: Research Site
state: Louisiana
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Bozeman
country: United States
facility: Research Site
state: Montana
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Mineola
country: United States
facility: Research Site
state: New York
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Shelby
country: United States
facility: Research Site
state: North Carolina
city: Bismarck
country: United States
facility: Research Site
state: North Dakota
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Kettering
country: United States
facility: Research Site
state: Ohio
city: Norman
country: United States
facility: Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Rapid City
country: United States
facility: Research Site
state: South Dakota
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Draper
country: United States
facility: Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Midlothian
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Salem
country: United States
facility: Research Site
state: Virginia
city: Brno
country: Czech Republic
facility: Research Site
city: Pardubice
country: Czech Republic
facility: Research Site
city: Praha 3
country: Czech Republic
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Carolina
country: Puerto Rico
facility: Research Site
city: Cidra
country: Puerto Rico
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: