Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3606
Source ID: NCT01856881
Associated Drug: Amg 876
Title: Multiple Ascending Dose Study in Subjects With Type 2 Diabetes
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: AMG 876
Outcome Measures: Primary: Subject incidence of treatment-emergent adverse events, Physical examinations, vitals, laboratory analytes, and ECGs, 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, 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8). | Secondary: AMG 876 serum PK parameters, Concentration-time profiles for AMG 876, 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), 43 Days (Cohorts 1, 3, 5 and 7), 57 Days (Cohorts 2, 4, 6 and 9) or 71 Days (Cohort 8).
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 86
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-03
Completion Date: 2015-03
Results First Posted:
Last Update Posted: 2015-11-06
Locations: Research Site, Chula Vista, California, 91911, United States|Research Site, Miramar, Florida, 33025, United States|Research Site, Overland Park, Kansas, 66212, United States|Research Site, Cincinnati, Ohio, 45255, United States|Research Site, San Antonio, Texas, 78209, United States|Research Site, Renton, Washington, 98057, United States
URL: https://clinicaltrials.gov/show/NCT01856881