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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
Ascending multiple doses of study drug administered SC
Research Site
Chula Vista, California, United States
Research Site
Miramar, Florida, United States
Research Site
Overland Park, Kansas, United States
Research Site
Cincinnati, Ohio, United States
Subject incidence of treatment-emergent adverse events
Physical examinations, vitals, laboratory analytes, and ECGs
Time frame: 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8).
Subject incidence of anti-AMG 876 antibodies
Laboratory analytes
Time frame: 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8).
AMG 876 serum PK parameters
Concentration-time profiles for AMG 876
Time frame: 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8).
Pharmacodynamic parameters
Concentration of fasting glucose, insulin, and C-peptide levels; Concentration-time profiles and AUC for metabolic parameters (eg, glucose, insulin, C peptide, glucagon, and non-esterified fatty acid concentrations); Fasting lipid levels (total cholesterol, low-density lipoprotein \[LDL\], high-density lipoprotein \[HDL\], and triglycerides); The following 7-point SMBG parameters: pre-meal average blood glucose, post-meal average blood glucose, 7-point average blood glucose, post-meal excursion, post-meal excursion average; Body weight, 24 hour weighted mean glucose(cohort 9 only)
Time frame: 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8).
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Research Site
San Antonio, Texas, United States
Research Site
Renton, Washington, United States