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

NCT03668808 | Completed Phase 4 Results DMC FDA Drug FDA Device

• 2 other identifiers: ISS-001227U1111-1210-7350
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Insulin Degludec; Insulin Glargine; Air Travel; Continuous Glucose Monitor

Outcome Measures

Primary Outcomes (1)

• Continuous Glucose Monitoring - Time in Range (70-140 mg/dl)

  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).

  During the initial 24 hours local time and starting within 2 hours after arrival

Secondary Outcomes (10)

• Continuous Glucose Monitoring - Time in Range (70-180 mg/dl)

  During the initial 24 hours local time and starting within 2 hours after arrival

• Mean ± SD CGM Glucose (mg/dl)

  In flight period of time and for 72 hours at each destination

• CGM % Time <70 mg/dl

  In flight period of time and for 72 hours at each destination

• CGM % Time 70-180 mg/dl

  In flight period of time and for 72 hours at each destination

• CGM % Time >180 mg/dl

  In flight period of time and for 72 hours at each destination

Study Arms (2)

Insulin Degludec

EXPERIMENTAL

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; Device: TRESIBA® FLEXTOUCH®

Insulin Glargine U100

ACTIVE COMPARATOR

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; Device: LANTUS® SOLOSTAR® INSULIN PEN

Interventions

Insulin Degludec DRUG

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.

Also known as: Tresiba

Insulin Degludec

Insulin Glargine DRUG

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.

Also known as: Lantus

Insulin Glargine U100

TRESIBA® FLEXTOUCH® DEVICE

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.

Also known as: Insulin Degludec

Insulin Degludec

LANTUS® SOLOSTAR® INSULIN PEN DEVICE

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.

Also known as: Insulin Glargine

Insulin Glargine U100

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥18 and ≤65 years of age.
• Type 1 diabetes mellitus (diagnosed clinically and treated with multiple daily injections of insulin) for ≥12 months.
• HbA1c \<10% within 30 days of being enrolled in the study
• 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.
• No contraindication to long-haul travel.
• 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.
• Willing and able to use a continuous glucose monitoring device (e.g. Dexcom G4).
• Ability to self-manage insulin therapy (verbal confirmation at screening visit) of a changed bolus insulin dose the preceding 2 months prior to screening.
• 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.

You may not qualify if:

• Current use of an insulin pump.
• Use within the last 3 months prior to enrollment visit 1 of any glucose-lowering drug other than insulin.
• 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).
• Proliferative retinopathy or maculopathy requiring treatment, according to the investigator.
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures.
• Any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial.
• 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.
• Known or suspected allergy to any of the trial products or related products.
• Receipt of any investigational drug or participation in other trials within 1 month prior to Visit 1.

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Novo Nordisk A/S: collaborator

Study Sites (2)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

inControl Diabetes Center

Honolulu, Hawaii, 96814, United States

Location

Related Publications (1)

• Bevier WC, Castorino KN, Axelrod C, Haroush G, Farfan CC, Shelton N, Nelson K, Spink LA, Liu H, Kerr D. Traveling Across Time Zones With Type 1 Diabetes: A Pilot Study Comparing Insulin Degludec With Insulin Glargine U100. Diabetes Care. 2022 Jan 1;45(1):67-73. doi: 10.2337/dc21-1524.

  PMID: 34716211 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin degludec; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Wendy C Bevier
• Organization: Sansum Diabetes Research Institute

wbevier@sansum.org

8056827638

Study Officials

• David Kerr, M.D.

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: November 16, 2018
• Primary Completion: September 19, 2020
• Study Completion: September 19, 2020
• Last Updated: November 1, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-10

Locations

US (2)