Single Ascending Dose Trial in Patients With Type 2 Diabetes

Amgen

Status and phase

Terminated

Phase 1

Conditions

Diabetes Mellitus

Treatments

Drug: AMG 876

Study type

Interventional

Funder types

Industry

Identifiers

NCT01492465

20100015

Details and patient eligibility

About

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

Enrollment

47 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)