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 |
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)
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