Phase 2
N=86
Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02544321 ↗Enrolled (actual)
86
Serious AEs
1.2%
Results posted
Sep 2021
Primary outcome: Primary: Mean Glucose — 182; 165; 181; 165 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bromocriptine (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Glucose |
182; 165; 181; 165 | — |
| PRIMARY Insulin Dosing |
0.9; 0.54; 0.88; 0.56 | — |
| PRIMARY Brachial Artery Distensibility |
6.35; 6.2; 6.14; 6.4 | — |
| PRIMARY Hyperemia Peripheral Arterial Tonometry (RH-PAT): Reactive Hyperemia Index (RHI) |
1.95; 2.1; 2.24; 2.2 | — |
| SECONDARY Mean Glycemic Variability |
71; 61; 73; 63 | — |
| SECONDARY Hypoglycemia Awareness |
2.15; 3.02; 2.00; 3.15; 1.36; 2.33 | — |
| SECONDARY Augmentation Index |
10.42; -2.0; 12.52; -2.5 | — |
| SECONDARY Heart Rate Variability (Adults) |
1.09; 1.14 | — |
| SECONDARY Heart Rate Variability (Adolescents) |
73; 76.4 | — |
| SECONDARY Sleep Duration |
433; 394; 414; 402; 486; 458 | — |
| SECONDARY Sleep Quality |
87.9; 90.4; 89.0; 90.4; 88.3; 89.7 | — |
| SECONDARY Metabolic Markers-glucose and Triglycerides |
11735; 9228; 11356; 12357; 3452; 3445 | — |
| SECONDARY Metabolic Markers-fatty Acids |
123334; 75561; 93661; 67497 | — |
| SECONDARY Metabolic Markers-glucagon |
2398; 2160; 2011; 2350 | — |
| SECONDARY Metabolic Markers - GLP1 |
661; 872; 766; 1196 | — |
| SECONDARY Metabolic Markers - Insulin |
4162; 2386; 4001; 2379 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Type 1 Diabetes (T1D) of >1 year duration based on a clinical course consistent with T1D and rapid conversion to insulin requirement after diagnosis.
- HbA1c 6.5-10% (adults) or any HbA1c up to 12% (pediatrics)
- age 12-60 years of age
Exclusion Criteria
- Any comorbid condition associated with inflammation, insulin resistance, or dyslipidemia including cancer, heart failure, active or end stage liver disease, kidney disease (except microalbuminuria), inadequately treated thyroid disease, or rheumatologic disease;
- Tobacco or marijuana use;
- Pregnancy;
- Regular or frequent oral steroid use;
- Current use of insulin sensitizing medications, neuroleptics, ergot-related medications, or triptan medications for migraine,
- Diagnosis or history of psychosis,
- Diabetes of other cause such as Maturity Onset Diabetes of the Young or cystic fibrosis-related diabetes.
Data sourced from ClinicalTrials.gov (NCT02544321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.