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NCT03668808 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Diabetes Mellitus, Type 1, sponsored by Sansum Diabetes Research Institute.

Completed
Registry status
Phase 4
Development phase
25
Enrollment target
2
Study locations

NCT03668808 is a Phase 4 study of Diabetes Mellitus, Type 1 that has completed, run by Sansum Diabetes Research Institute. The registered enrollment target is 25 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03668808, a Phase 4 study of Diabetes Mellitus, Type 1, has completed, sponsored by Sansum Diabetes Research Institute.

COMPLETED
Registry status
Phase 4
Development phase
25 participants
Enrollment target
2
Study locations

Study 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 Studied

Diabetes Mellitus, Type 1

Interventions

  • DRUG Insulin Glargine
  • DRUG Insulin Degludec
  • DEVICE TRESIBA® FLEXTOUCH®
  • DEVICE LANTUS® SOLOSTAR® INSULIN PEN

Study Locations (2)

California

  • Sansum Diabetes Research Institute - Santa Barbara

Hawaii

  • inControl Diabetes Center - Honolulu

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2018-11-16
Est. Completion 2020-09-19
Phase Phase 4

Sponsor

Sansum Diabetes Research Institute

33 total trials

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What the Registry Record Tells You About NCT03668808

The ClinicalTrials.gov registry entry for NCT03668808 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (98% lower). The listed sponsor is Sansum Diabetes Research Institute, which has 33 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 4 interventions - of which Insulin Glargine is the first listed.

NCT03668808 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Hawaii.

Frequently Asked Questions

What is clinical trial NCT03668808 about?

NCT03668808 is a clinical study titled "Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.". 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. W...

What is the current status of trial NCT03668808?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2018-11-16. Estimated completion is 2020-09-19.

What conditions does trial NCT03668808 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.

What interventions are being tested in trial NCT03668808?

The interventions under investigation include: Insulin Glargine (DRUG), Insulin Degludec (DRUG), TRESIBA® FLEXTOUCH® (DEVICE), LANTUS® SOLOSTAR® INSULIN PEN (DEVICE).

Who is sponsoring clinical trial NCT03668808?

This trial is sponsored by Sansum Diabetes Research Institute, which has 33 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03668808 being conducted?

This trial has 2 study locations across California, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.