AMG 151 Amgen Protocol Number 20100761



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:3/30/2013
Start Date:September 2011
End Date:April 2013
Contact:Amgen Call Center
Phone:866-572-6436

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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.


Inclusion Criteria:

- Age 18 to 65 years, inclusive

- Diagnosis of type 2 diabetes mellitus

- HbA1c levels 7.5% to 10.0%, inclusive, at screening

- Fasting C-peptide levels ≥ 0.2 nmol/L at screening

- BMI ≥ 25 to < 40 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 (± 5%) 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 outpatient insulin at any time 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

- Known history of HIV, hepatitis B or hepatitis C

- 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 > 90 mm Hg or systolic
pressure > 150 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
We found this trial at
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