Trial · NCT02544321

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

NCT02544321, Phase 2, Completed, University of Colorado, Denver; results first posted 2021-09-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes. Trials, record NCT02544321. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02544321

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bromocriptine Quick Release (BCQR) as Adjunct Therapy in Type 1 Diabetes
NCT number: NCT02544321
Status: Completed
Phases: Phase 2
Enrollment: 108 participants, actual
Lead sponsor: University of Colorado, Denver
Conditions: Type 1 Diabetes
Interventions: Bromocriptine, Placebo
First posted: 2015-09-09
Last updated: 2021-09-13
Results first posted: 2021-09-13

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Glucose	4 weeks	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
Primary	Insulin Dosing	4 weeks	At the end of each 4 week intervention period, we will measure the effect of BCQR on insulin dosing (units//kg/day)
Primary	Brachial Artery Distensibility	4 weeks	At the end of each 4 week intervention period, we will measure the brachial artery distensibility as a measure of vascular stiffness by Dynapulse (%/mmHg). A larger number indicates less stiffness (ie greater compliance).
Primary	Hyperemia Peripheral Arterial Tonometry (RH-PAT): Reactive Hyperemia Index (RHI)	4 weeks	At the end of each 4 week intervention period, we will measure the reactive hyperemia Index (RHI). The Reactive Hyperemia Index (RHI) measures increased bloodflow after vascular occlusion. Higher scores indicate lower CVD risk and a better outcome, Scores of less than 1.67 may be considered abnormal. Scores of 1.67 1.67-2.09 may be considered borderline, and scores of 2.10 or higher my be considered normal.
Secondary	Mean Glycemic Variability	4 weeks	At the end of each 4 week intervention period, we will measure the effect of Bromocriptine Quick Release on glycemic variability throughout the day (mg/dl), measured as SD of all glucose values throughout the last 7 days of intervention. Incorrectly initially entered as primary outcome. per protocol this has always been a secondary outcome.
Secondary	Hypoglycemia Awareness	4 weeks	At the end of each 4 week intervention period, we will measure Hypoglycemia Awareness using the Gold method (7 point Likert scale: Possible scores range from 1 to 7. higher scores indicate more impaired awareness of hypoglycemia, and a worse outcome), Clarke method (8 question questionnaire characterizing hypoglycemia awareness. Possible scores range from 0-7, with higher scores indicating less awareness and a worse outcome), and the McAuley score (list of symptoms with a 7 point Likert scale for each. Possible scores range from 1-7 for each item, and are averaged across all symptoms, for a total possible score range of 1-7, with higher scores indicating more symptom awareness, and a better outcome). Incorrectly initially entered as primary outcome. per protocol this has always been a secondary outcome.
Secondary	Augmentation Index	4 weeks	At the end of each 4 week intervention period, the % will be measured by SyphgmoCor. The Augmentation Index measures vascular stiffness by comparing pulse pressure of the reflected wave to the primary wave. HIGHER scores indicate greater vascular stiffness and higher cardiovascular risk, but a normal range has not been clearly defined. Presented as AI normalized to a heart rate of 75 (AI75).
Secondary	Heart Rate Variability (Adults)	4 weeks	At the end of each 4 week intervention period we will measure the autonomic function by ECG. Ratio of maximum heart rate/minimum heartrate during a valsalva maneuver.
Secondary	Heart Rate Variability (Adolescents)	4 weeks	At the end of each 4 week intervention period we will measure the autonomic function by HRV measured by endopat and reported using the single gold standard measure of SDNN (standard deviation of beat to beat time interval). Normal is \>100, 50-100 indicates compromised autonomic function.
Secondary	Sleep Duration	4 weeks	At the end of each 4 week intervention period, measurements of sleep duration on weekdays and weekends (minutes) by a Philips Spectrum Plus sleep monitor will be obtained.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Glucose	4 weeks	Data reflects average glucose levels.	mg/dl	LEAST_SQUARES_MEAN
PRIMARY	Insulin Dosing	4 weeks		units//kg/day	LEAST_SQUARES_MEAN
PRIMARY	Brachial Artery Distensibility	4 weeks	Compared for placebo versus BCQR after 4 weeks of treatment.	%/mmHg	LEAST_SQUARES_MEAN
PRIMARY	Hyperemia Peripheral Arterial Tonometry (RH-PAT): Reactive Hyperemia Index (RHI)	4 weeks		score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Mean Glycemic Variability	4 weeks		mg/dl	LEAST_SQUARES_MEAN
SECONDARY	Hypoglycemia Awareness	4 weeks	Unadjusted least square means by mixed procedure.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Augmentation Index	4 weeks		Percentage of pressure wave	LEAST_SQUARES_MEAN
SECONDARY	Heart Rate Variability (Adults)	4 weeks		ratio	LEAST_SQUARES_MEAN
SECONDARY	Heart Rate Variability (Adolescents)	4 weeks		milliseconds	LEAST_SQUARES_MEAN
SECONDARY	Sleep Duration	4 weeks		minutes	MEAN

1 to 10 of 16Source ClinicalTrials.gov

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Results by group80

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Glucose	Bromocriptine QR (Adolescents)	182	Standard Error 5	mg/dl
Mean Glucose	Bromocriptine QR (Adults)	165	Standard Error 5	mg/dl
Mean Glucose	Placebo (Adolescents)	181	Standard Error 5	mg/dl
Mean Glucose	Placebo (Adults)	165	Standard Error 5	mg/dl
Insulin Dosing	Bromocriptine QR (Adolescents)	0.9	Standard Error .03	units//kg/day
Insulin Dosing	Bromocriptine QR (Adults)	0.54	Standard Error .02	units//kg/day
Insulin Dosing	Placebo (Adolescents)	0.88	Standard Error .03	units//kg/day
Insulin Dosing	Placebo (Adults)	0.56	Standard Error 0.02	units//kg/day
Brachial Artery Distensibility	Bromocriptine QR (Adolescents)	6.35	Standard Error 0.19	%/mmHg
Brachial Artery Distensibility	Bromocriptine QR (Adults)	6.2	Standard Error 0.2	%/mmHg

1 to 10 of 80Source ClinicalTrials.gov

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Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Bromocriptine QR, Then Placebo	43
Overall Study	STARTED	Placebo, Then Bromocriptine QR	43
Overall Study	Completed First Treatment	Bromocriptine QR, Then Placebo	43
Overall Study	Completed First Treatment	Placebo, Then Bromocriptine QR	41
Overall Study	Completed Washout	Bromocriptine QR, Then Placebo	43
Overall Study	Completed Washout	Placebo, Then Bromocriptine QR	41
Overall Study	Started Second Treatment	Bromocriptine QR, Then Placebo	42
Overall Study	Started Second Treatment	Placebo, Then Bromocriptine QR	40
Overall Study	COMPLETED	Bromocriptine QR, Then Placebo	41
Overall Study	COMPLETED	Placebo, Then Bromocriptine QR	39

1 to 10 of 12Source ClinicalTrials.gov

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Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	nausea	Gastrointestinal disorders	Bromocriptine QR (Adolescents)	13	42
other	nausea	Gastrointestinal disorders	Bromocriptine QR (Adults)	17	42
other	nausea	Gastrointestinal disorders	Placebo (Adolescents)	1	42
other	nausea	Gastrointestinal disorders	Placebo (Adults)	3	42
other	orthostasis	Vascular disorders	Bromocriptine QR (Adolescents)	4	42
other	orthostasis	Vascular disorders	Bromocriptine QR (Adults)	6	42
other	orthostasis	Vascular disorders	Placebo (Adolescents)	0	42
other	orthostasis	Vascular disorders	Placebo (Adults)	2	42
other	fatigue	General disorders	Bromocriptine QR (Adolescents)	1	42
other	fatigue	General disorders	Bromocriptine QR (Adults)	5	42

1 to 10 of 24Source ClinicalTrials.gov

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Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bromocriptine QR (Adolescents)	1	42
Total, all-cause mortality	Bromocriptine QR (Adults)	1	42
Total, all-cause mortality	Placebo (Adolescents)	0	42
Total, all-cause mortality	Placebo (Adults)	0	42
Total, other adverse events	Bromocriptine QR (Adolescents)	13	42
Total, other adverse events	Bromocriptine QR (Adults)	17	42
Total, other adverse events	Placebo (Adolescents)	1	42
Total, other adverse events	Placebo (Adults)	3	42
Total, serious adverse events	Bromocriptine QR (Adolescents)	1	42
Total, serious adverse events	Bromocriptine QR (Adults)	1	42

1 to 10 of 12Source ClinicalTrials.gov

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Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35712800	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UL1TR001082	Colorado Clinical and Translational Sciences Institute	SOKOL, RONALD J.	UNIVERSITY OF COLORADO DENVER	NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES	2013 to 2017

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02544321

GET https://conductscience.org/api/trials/v1/NCT02544321/results?page=2

API reference For AI assistants