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Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose

NCT04623086 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-02-28

Study results available
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Summary

This study evaluates direct switching vs use of a bridging dose from insulin glargine to insulin degludec in type 1 DM patients. Half of the participants will receive a bridging insulin glargine dose along with the 1st dose of degludec, while other half will receive a placebo and 1st dose of degludec.

Conditions

Interventions

DRUG

Insulin Degludec

Insulin Degludec injection

DRUG

Insulin Glargine

Insulin Glargine injection

DRUG

Placebo

9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection

Sponsors & Collaborators

Principal Investigators

  • Arthi Thirumalai, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-14
Primary Completion
2022-09-07
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04623086 on ClinicalTrials.gov