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

NCT ID: NCT03668808

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-16
• Study Completion Date: 2020-09-19

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.

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).

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Insulin Degludec

Intervention Type: 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.

TRESIBA® FLEXTOUCH®

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Insulin Glargine

Intervention Type: 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.

LANTUS® SOLOSTAR® INSULIN PEN

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Tresiba; Lantus; Insulin Degludec; Insulin Glargine

Eligibility 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.

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Sansum Diabetes Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Kerr, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sansum Diabetes Research Institute

Locations

Sansum Diabetes Research Institute

Santa Barbara, California, United States

inControl Diabetes Center

Honolulu, Hawaii, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34716211 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

U1111-1210-7350

Identifier Type: REGISTRY

Identifier Source: secondary_id

ISS-001227

Identifier Type: -

Identifier Source: org_study_id