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

Amgen1 site in 1 country47 target enrollmentNovember 2011

ConditionsDiabetes Mellitus

InterventionsAMG 876

DrugsAMG 876

Overview

Phase: Phase 1
Intervention: AMG 876
Conditions: Diabetes Mellitus
Sponsor: Amgen
Enrollment: 47
Locations: 1
Primary Endpoint: Subject incidence of treatment-emergent adverse events
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

October 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

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)