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Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.

NCT03668808 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-11-01

Study results available
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Summary

The purpose of the proposed study is to compare insulin Degludec \[TRESIBA® (insulin degludec injection)\] with insulin Glargine U100 \[Lantus® (insulin glargine injection)\] to determine the basal insulin of choice for adults with type 1 diabetes (T1D) who fly non-stop across multiple time zones. With the introduction of Degludec as basal insulin for T1D and the opportunity to vary time of injection between 8 and 40 hours, the use of Degludec as a basal insulin may make it easier for both people living with T1D and diabetologists to plan long-haul travel compared to the use of existing basal insulins when crossing multiple time zones.The study hypothesis is that once daily Degludec as the basal insulin will provide better glycemic control for people with type 1 diabetes on multiple daily injections who are traveling non-stop across multiple time zones than once daily Glargine U100.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Insulin Degludec

Subjects will use Insulin Degludec (Tresiba) with TRESIBA® FLEXTOUCH® pens as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.

DRUG

Insulin Glargine

Subjects will use Insulin Glargine (Lantus) with LANTUS® SOLOSTAR® INSULIN PEN as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.

DEVICE

TRESIBA® FLEXTOUCH®

Subjects will use Tresiba FlexTouch pens when using Tresiba as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.

DEVICE

LANTUS® SOLOSTAR® INSULIN PEN

Subjects will use Lantus SoloStar insulin pens when using Lantus as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Sansum Diabetes Research Institute

    lead OTHER

Principal Investigators

  • David Kerr, M.D. · Sansum Diabetes Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-16
Primary Completion
2020-09-19
Completion
2020-09-19
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03668808 on ClinicalTrials.gov