Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes
Status:
Completed
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
Type 1 diabetes (T1D) continues to be a disease plagued by hyperglycemia, insulin resistance
(IR), and increased cardiovascular disease (CVD) despite advances in insulin delivery and
glucose monitoring. Therefore new approaches are needed. Bromocriptine (BC), a dopamine (DA)
agonist, has long been widely used for treating Parkinson's disease and prolactinoma. Its
recent approval in a quick release formulation, BCQR, for type 2 diabetes (T2D) is an
exciting development, representing a novel mechanism for improving IR. BCQR has not been
studied in T1D, but it's mechanism of action, mechanistic studies, and preliminary data
support the proposed study of possible benefits of BCQR on insulin action, glycemic control,
and the vasculature in T1D. This study has received an exemption from the FDA to study BCQR
in adults with T1D and an IND approval (131360) to study BCQR in adolescents with T1D. This
is a random-order, double-blind, placebo-controlled study of a 4 week intervention. Outcomes
will include fasting and postprandial glucose, glycemic variability, insulin dosing,
hypoglycemia frequency and awareness, sleep quality, and metabolic hormone levels.