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NCT02544321 · ClinicalTrials.gov registry record · Phase 2
Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes
A Phase 2 study of Type 1 Diabetes, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
- 1
- Study location
NCT02544321: Completed Phase 2 study of Type 1 Diabetes, sponsored by University of Colorado, Denver.
NCT02544321 is a Phase 2 study of Type 1 Diabetes that has completed, run by University of Colorado, Denver. The registered enrollment target is 108 participants, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02544321, a Phase 2 study of Type 1 Diabetes, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
At the end of each 4 week intervention period, we will measure the effect of Bromocriptine Quick Release on average glucose levels (mg/dl) by continuous glucose monitoring
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Bromocriptine
Study Locations (1)
Colorado
- University of Colorado-Denver, Anshutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2015-09 |
| Est. Completion | 2019-06 |
| Phase | Phase 2 |
What the finished NCT02544321 record still lists
NCT02544321 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 766-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02544321 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT02544321 about?
NCT02544321 is a clinical study titled "Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes". 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 w...
What is the current status of trial NCT02544321?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2015-09. Estimated completion is 2019-06.
What conditions does trial NCT02544321 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT02544321?
The interventions under investigation include: Placebo (OTHER), Bromocriptine (DRUG).
Who is sponsoring clinical trial NCT02544321?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02544321 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02544321's enrollment target sits among peer trials
108 53rd of 198 higher than 146 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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