Protocol Information

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Title A PHASE Ib, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, MULTIPLE ASCENDINGDOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SUBCUTANEOUS BFKB8488A IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
Description A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus

Study visits will be in Williamsville
Objective This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending−dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 6 weeks), a 12-week treatment period, and a 6-week follow-up period.
Principal Investigator DANDONA, PARESH
Age Group Adult
Drugs Involved
Clinical Trials.gov http://www.clinicaltrials.gov/ct2/show/NCT03060538/
Status Open
Key Eligibility Ages 18-75
Type 2 Diabetes
Disease Group Diabetes; Endocrine Diseases
Treatment BFKB8488A
Contact MEGHAN KIRSCH
716-898-1950
meghanki@buffalo.edu