Single Ascending Dose Trial in Patients With Type 2 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:November 2011
End Date:September 2012
Contact:Amgen Call Center
Phone:866-572-6436

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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 876 in Subjects With Type 2 Diabetes


The purpose of this study is to determine whether AMG 876 is safe and well tolerated in
subjects with type 2 diabetes.


Inclusion Criteria:

- Subject has provided written informed consent

- Men and women between the ages of 18 and 65, inclusive at the time of randomization

- Women must be of documented non-reproductive potential (ie, postmenopausal [see
definition below]; OR history of hysterectomy; OR history of bilateral tubal
ligation; OR history of bilateral oophorectomy).

- Diagnosed with type 2 diabetes

- HbA1c ≥ 6.5% and ≤ 10%

- Fasting C-peptide value ≥ 0.8 ng/mL

- Men must agree for the duration of the study and continuing for 4 weeks after the
dose of study drug, to practice a highly effective method of birth control. Highly
effective methods of birth control include sexual abstinence, vasectomy or a condom
with spermicide (men) in combination with either barrier methods, hormonal birth
control or IUD (women).

- Men must agree to not donate sperm for the duration of the study and continuing for 4
weeks after the dose of study drug.

- Body mass index between ≥ 25.0 kg/m2 and ≤ 40.0 kg/m2 at screening

- Negative screening test for alcohol and potential drugs of abuse at screening and day
-2, unless medication is prescribed by a physician and approved by the principal
investigator and Amgen medical monitor

Exclusion Criteria:

- Men with partners who are pregnant at the time of screening or men with partners who
plan to become pregnant during the study

- Women who are pregnant or breastfeeding History or evidence of a clinically
significant disorder, condition or disease that, in the opinion of the principal
investigator or Amgen medical monitor would pose a risk to subject safety or
interfere with the study evaluation, procedures or completion

- Evidence or history at screening of diabetic complications with significant end-organ
damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance < 60
mL/min/1.73m2 (calculated using the Modification of Diet in Renal Disease formula),
or macroalbuminuria (ie, ≥ +1 proteinuria on urinalysis), diabetic neuropathy
complicated by neuropathic ulcers, or severe autonomic neuropathy with gastroparesis,
chronic diarrhea, or hypoglycemic unawareness

- Significant cardiac disease, including but not limited to evidence or history of
coronary artery disease, unstable angina, congestive heart failure, known arrhythmias
of ventricular etiology, unexplained syncope or syncope/seizures related to
arrhythmia

- Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface
antigen (Hbs Ag), or hepatitis C virus antibodies

- An unstable medical condition, defined as having been hospitalized within 28 days
before day -1, major surgery within 6 months before day -1, or otherwise unstable in
the judgment of the investigator (eg, risk of complications or adverse events
unrelated to study participation)
We found this trial at
3
sites
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Grand Island, NE
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Dallas, TX
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Houston, TX
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