Single Ascending Dose Trial in Patients With Type 2 Diabetes
- Registration Number
- NCT01492465
- Lead Sponsor
- Amgen
- Brief Summary
The purpose of this study is to determine whether AMG 876 is safe and well tolerated in subjects with type 2 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 47
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AMG 876 AMG 876 - Placebo AMG 876 -
- Primary Outcome Measures
Name Time Method Subject incidence of treatment-emergent adverse events 29 days Physical examinations, vitals, clinical laboratories, and ECGs
Safety laboratory analytes, vital signs, and ECGs 29 days laboratory analytes, vital signs, and ECGs
Subject incidence of anti-AMG 876 antibodies. 29 days laboratories analytes
- Secondary Outcome Measures
Name Time Method AMG 876 serum PK parameters 29 days Concentration-time profiles for AMG 876
Pharmacodynamic parameters: 29 days Concentration of fasting glucose, insulin and c-peptide levels; Concentration-time profiles and AUC for metabolic parameters (eg, glucose, insulin, c-peptide, glucagon and free fatty acid concentrations) following a mixed meal tolerance test; Lipid levels (ie, total cholesterol, LDL, HDL, and triglycerides); Body weight.
Trial Locations
- Locations (1)
Research Site
🇺🇸San Antonio, Texas, United States