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NCT03542682

The Effect of Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes

Completed NA Results posted Last updated 13 February 2024
What this trial tests

NA trial testing Quick Bolus in Type1diabetes in 11 participants. Completed in 23 September 2022.

Timeline
30 May 2018
Primary endpoint
23 September 2022
23 September 2022

Quick facts

Lead sponsorYale University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposebasic science
Enrollment11
Start date30 May 2018
Primary completion23 September 2022
Estimated completion23 September 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

Adults 18 to 30, any sex, with Type1diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Maximum Glucose Infusion Rate Primary · 300 minutes

time to maximum glucose infusion rate (GIR) in minutes

GroupValue95% CI
Quick Bolus116.5474.74 – 158.34
Standard Bolus172.21130.41 – 214.01
Maximum Glucose Infusion Rate Secondary · 300 minutes

maximum glucose infusion rate (GIRmax)

GroupValue95% CI
Quick Bolus8.424.91 – 11.92
Standard Bolus7.453.95 – 10.96
Area Under the Curve for the Glucose Infusion Rate Secondary · 300 minutes

area under the curve for the glucose infusion rate

GroupValue95% CI
Quick Bolus1204.29716.72 – 1691.86
Standard Bolus1072.44584.86 – 1560.01

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 5 hours post intervention for each intervention. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Individuals Given Standard Bolus
Serious: 0/8 (0%)
Deaths: 0/8
Individuals Given Quick Bolus
Serious: 0/9 (0%)
Deaths: 0/9
Other adverse events (1 terms — click to expand)

ReactionSystemIndividuals Given Standard…Individuals Given Quick Bo…
Common ColdInfections and infestations

Data from ClinicalTrials.gov NCT03542682 adverse events section.

Sponsor's own description

Rapid Action Insulin (RAI) absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Type1diabetes

Currently open trials in the same condition.

Other Yale University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03542682.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing