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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 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 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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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.

Conditions Studied

Type 1 Diabetes

Interventions

  • OTHER Placebo
  • DRUG Bromocriptine

Study Locations (1)

Colorado

  • University of Colorado-Denver, Anshutz Medical Campus - Aurora

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2015-09
Est. Completion 2019-06
Phase Phase 2

Sponsor

University of Colorado, Denver

1,283 total trials

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What the Registry Record Tells You About NCT02544321

The ClinicalTrials.gov registry entry for NCT02544321 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (87% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.