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Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones. (SafrTravlT1D)

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ClinicalTrials.gov Identifier: NCT03668808
Recruitment Status : Enrolling by invitation
First Posted : September 13, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Sansum Diabetes Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: Insulin Degludec Drug: Insulin Glargine Device: TRESIBA® FLEXTOUCH® Device: LANTUS® SOLOSTAR® INSULIN PEN Phase 4

Detailed Description:
This study will be an open-label, single center, pilot study. Participants will be randomized to either Glargine U100 or Degludec as the basal insulin, then a 2 week break, and followed by a cross-over to the other insulin. Each study period will begin in Honolulu, Hawaii (HI) (airport code HNL) with a non-stop flight to Newark, New Jersey (NJ) (EWR) lasting approximately 10 hours with a 6 hour time difference between destinations. After up to 72 hours in EWR, participants will return to Honolulu and spend up to 72 hours at that destination. Investigators plan to recruit 25 adults with established T1D currently being treated with multiple daily injections of insulin (MDI).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Subjects will begin in Honolulu, HI (HNL), fly to Newark (EWR) where they will stay for up to 72 hours followed by a return long-haul flight back to Honolulu with up to 72 hours at this destination. This journey will be repeated after a 2 week period when subjects return to their original insulin treatment regimen and then switch to the alternative basal insulin.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Travelling Across Multiple Time Zones. A Pilot Study.
Actual Study Start Date : November 16, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Insulin Degludec
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Degludec and the TRESIBA® FLEXTOUCH® pens during a long-haul flight and randomized to this arm first or second.
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.
Other Name: Tresiba

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.
Other Name: Insulin Degludec

Active Comparator: Insulin Glargine U100
Subjects with type 1 diabetes and on multiple daily injections will use basal insulin Glargine U100 and the LANTUS® SOLOSTAR® INSULIN PEN during a long-haul flight and randomized to this arm first or second.
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.
Other Name: Lantus

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.
Other Name: Insulin Glargine




Primary Outcome Measures :
  1. Continuous Glucose Monitoring - Time in range (70-140 mg/dl) [ Time Frame: During the initial 24 hours local time and starting within 2 hours after arrival ]
    Time in range (70-140 mg/dl) [percentage of glucose readings or hours per day] by continuous glucose monitoring (CGM) during the initial 24 hours local time (starting within 2 hours after arriving) in Newark, NJ after flying 9-10 hours West to East (from Honolulu, HI) and after the return journey from Newark to Honolulu (flying East to West).


Secondary Outcome Measures :
  1. Continuous Glucose Monitoring - Time in range (70-180 mg/dl) [ Time Frame: During the initial 24 hours local time and starting within 2 hours after arrival ]
    Time in range (70-180 mg/dl) [percentage of glucose readings or hours per day] by continuous glucose monitoring (CGM) during the first 24 hours after arriving in HNL and EWR (starting within 2 hours after arrival).

  2. Mean ± standard deviation (SD) CGM glucose (mg/dl) [ Time Frame: In flight period of time and for 72 hours at each destination ]
    Mean ± SD CGM glucose (mg/dl) by CGM

  3. CGM % time <50 mg/dl [ Time Frame: In flight period of time and for 72 hours at each destination ]
    % time <50 mg/dl by CGM

  4. CGM % time <60 mg/dl [ Time Frame: In flight period of time and for 72 hours at each destination ]
    % time <60 mg/dl by CGM

  5. CGM % time <70 mg/dl [ Time Frame: In flight period of time and for 72 hours at each destination ]
    % time <70 mg/dl by CGM

  6. CGM % time 70-180 mg/dl [ Time Frame: In flight period of time and for 72 hours at each destination ]
    % time 70-180 mg/dl by CGM

  7. CGM % time >180 mg/dl [ Time Frame: In flight period of time and for 72 hours at each destination ]
    % time >180 mg/dl by CGM

  8. CGM % time >250 mg/dl [ Time Frame: In flight period of time and for 72 hours at each destination ]
    % time >250 mg/dl by CGM

  9. CGM % time >300 mg/dl [ Time Frame: In flight period of time and for 72 hours at each destination ]
    % time >300 mg/dl by CGM

  10. CGM - Standard Deviation (SD) and Coefficient of Variation (CV) [ Time Frame: In flight period of time and for 72 hours at each destination ]
    Standard deviation and coefficient of variation of CGM values

  11. CGM Fasting Blood Glucose (FBG) [ Time Frame: At 0600 local time ]
    Fasting Blood Glucose (FBG) using CGM

  12. Cortisol and Melatonin measurement by saliva [ Time Frame: Immediately before a flight, during the flight, immediately after the flight, and after 48 hours at the destination and immediately before the beginning of each flight ]
    Salivary cortisol and melatonin samples

  13. Liverpool Jet-Lag Questionnaire [ Time Frame: Immediately before a flight, during the flight, immediately after the flight, and after 48 hours at the destination and immediately before the beginning of each flight ]
    Questionnaire about jet-lag

  14. Fear of hypoglycemia measured by Hypoglycemic Confidence Questionnaire [ Time Frame: Immediately before a flight, during the flight, immediately after the flight, and after 48 hours at the destination and immediately before the beginning of each flight ]
    Questionnaire & scale for fear of hypoglycemia

  15. Sleep duration and quality measured by Fitbit and/or ActiGraph [ Time Frame: During the flight and up to 72 hours at destination ]
    Measurement of sleep duration and quality

  16. Physical Activity measured by Fitbit and/or ActiGraph [ Time Frame: During the flight and up to 72 hours at destination ]
    Measurement of physical activity



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females ≥18 and ≤65 years of age.
  2. Type 1 diabetes mellitus (diagnosed clinically and treated with multiple daily injections of insulin) for ≥12 months.
  3. HbA1c <10% within 30 days of being enrolled in the study
  4. Current treatment with any basal insulin analogue as the once daily basal insulin given in the evening (22) and no fewer than three injections with rapid acting bolus insulin (e.g. insulin aspart, insulin lispro, or insulin glulisine) as mealtime bolus insulin therapy.
  5. No contraindication to long-haul travel.
  6. No recurrent severe hypoglycemia (more than 1 severe hypoglycemic event requiring hospitalization during the last 12 months), or hypoglycemia unawareness as judged by a score of >4 on the Gold score (23), or hospitalization for diabetic ketoacidosis during the previous 6 months.
  7. Willing and able to use a continuous glucose monitoring device (e.g. Dexcom G4).
  8. Ability to self-manage insulin therapy (verbal confirmation at screening visit) of a changed bolus insulin dose the preceding 2 months prior to screening.
  9. Ability and willingness to adhere to the protocol, including performance of self-monitored blood glucose (SMBG) readings and self-adjustment of insulin doses according to protocol.

    -

Exclusion Criteria:

  1. Current use of an insulin pump.
  2. Use within the last 3 months prior to enrollment visit 1 of any glucose-lowering drug other than insulin.
  3. Initiation or significant change of any systemic treatment which, in the investigator's opinion, could interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers or monoamine oxidase inhibitors (inhaled corticosteroids allowed).
  4. Proliferative retinopathy or maculopathy requiring treatment, according to the investigator.
  5. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures.
  6. Any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial.
  7. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or cooperation, including subjects not able to read or write, and known or suspected abuse of alcohol, narcotics, or illicit drugs.
  8. Known or suspected allergy to any of the trial products or related products.
  9. Receipt of any investigational drug or participation in other trials within 1 month prior to Visit 1.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668808


Locations
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United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
United States, Hawaii
inControl Diabetes Center
Honolulu, Hawaii, United States, 96814
Sponsors and Collaborators
Sansum Diabetes Research Institute
Novo Nordisk A/S
Investigators
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Principal Investigator: David Kerr, M.D. Sansum Diabetes Research Institute

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Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT03668808     History of Changes
Other Study ID Numbers: ISS-001227
U1111-1210-7350 ( Registry Identifier: Universal Trial Number - World Health Organization (WHO) )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided to whether to make individual participant data available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Sansum Diabetes Research Institute:
Insulin Degludec
Insulin Glargine
Air Travel
Continuous Glucose Monitor

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs