Multiple Ascending Dose Study in Subjects With Type 2 Diabetes



Status:Terminated
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:March 2013
End Date:March 2015

Use our guide to learn which trials are right for you!

A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-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 evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamics following ascending multiple doses of AMG 876 in subjects with type 2
diabetes.


Inclusion Criteria:

- Male and female subjects ≥ 18 to ≤ 65 years of age at the time of randomization

- Female subjects must be of documented non-reproductive potential

- Diagnosed with type 2 diabetes

- HbA1c ≥ 6.5% and ≤ 10%

- Fasting C-peptide value ≥ 0.8 ng/mL

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

Exclusion Criteria:

- Female subjects who are lactating/breastfeeding or who plan to breastfeed while on
study through 4 weeks after receiving the last dose of study drug.

- Male subjects with partners who are pregnant or planning to become pregnant while the
subject is on study through 4 weeks after receiving the last dose of study drug

- Evidence or history at screening of diabetic complications with significant end-organ
damage, eg, proliferative retinopathy and/or macular edema, estimated glomerular
filtration rate < 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 atrial or ventricular etiology, unexplained syncope, or syncope/seizures related
to arrhythmia

- Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood
pressure ≥ 90 mmHg) either on or off therapy at screening

- Triglycerides ≥ 500 mg/dL (5.64 mmol/L) at screening

- Hepatic liver enzymes ALT, AST, alkaline phosphatase (ALP), or total bilirubin (TBIL)
levels > 1.5 times the upper limit of normal (ULN) at screening

- Fasting blood glucose > 270 mg/dL at the screening visit

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

- 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
6
sites
?
mi
from
Miramar, FL
Click here to add this to my saved trials
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
?
mi
from
Renton, WA
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials