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Clinical Trial Details

Trial ID: L2301
Source ID: NCT01492465
Associated Drug: Amg 876
Title: Single Ascending Dose Trial in Patients 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, clinical laboratories, and ECGs, 29 days|Safety laboratory analytes, vital signs, and ECGs, laboratory analytes, vital signs, and ECGs, 29 days|Subject incidence of anti-AMG 876 antibodies., laboratories analytes, 29 days | Secondary: AMG 876 serum PK parameters, Concentration-time profiles for AMG 876, 29 days|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 free fatty acid concentrations) following a mixed meal tolerance test; Lipid levels (ie, total cholesterol, LDL, HDL, and triglycerides); Body weight., 29 days
Sponsor/Collaborators: Sponsor: Amgen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 47
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2011-11
Completion Date: 2012-10
Results First Posted:
Last Update Posted: 2013-02-15
Locations: Research Site, Omaha, Nebraska, 68154, United States|Research Site, San Antonio, Texas, 78209, United States|San Antonio, Texas, 78209, United States
URL: https://clinicaltrials.gov/show/NCT01492465

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress