Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02544321
Study type	Interventional
Source	University of Colorado, Denver
Contact
Status	Completed
Phase	Phase 2
Start date	September 2015
Completion date	June 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05653518` - Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes	N/A
Enrolling by invitation	`NCT05515939` - Evaluating the InPen in Pediatric Type 1 Diabetes
Completed	`NCT05109520` - Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
Recruiting	`NCT04016987` - Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes	N/A
Active, not recruiting	`NCT04190368` - Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes	N/A
Recruiting	`NCT05413005` - Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus	Early Phase 1
Active, not recruiting	`NCT04668612` - Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes	N/A
Completed	`NCT02837094` - Enhanced Epidermal Antigen Specific Immunotherapy Trial -1	Phase 1
Recruiting	`NCT05414409` - The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action	Phase 2
Recruiting	`NCT05670366` - The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes	N/A
Active, not recruiting	`NCT05418699` - Real-life Data From Diabetic Patients on Closed-loop Pumps
Completed	`NCT04084171` - Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6	N/A
Recruiting	`NCT06144554` - Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
Recruiting	`NCT05153070` - Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes	Phase 2
Recruiting	`NCT05379686` - Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes	N/A
Completed	`NCT05281614` - Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D	Early Phase 1
Withdrawn	`NCT04259775` - Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes	N/A
Active, not recruiting	`NCT01600924` - Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
Completed	`NCT02855307` - Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes	Phase 2
Completed	`NCT02750527` - Pediatric Population Screening for Type 1 Diabetes and Familial Hypercholesterolemia in Lower Saxony, Germany