Phase 4
N=25
Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT03668808 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Continuous Glucose Monitoring - Time in Range (70-140 mg/dl) — 36.3; 45.6; 37.2; 43.9 percentage of Time in Range 70-140mg/dL — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin Degludec (Drug); Insulin Glargine (Drug); TRESIBA® FLEXTOUCH® (Device); LANTUS® SOLOSTAR® INSULIN PEN (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sansum Diabetes Research Institute
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Glucose Monitoring - Time in Range (70-140 mg/dl) |
36.3; 45.6; 37.2; 43.9 | <0.05 sig |
| SECONDARY Continuous Glucose Monitoring - Time in Range (70-180 mg/dl) |
55.0; 62.3; 54.5; 61.2 | <0.05 sig |
| SECONDARY Mean ± SD CGM Glucose (mg/dl) |
166.3; 158.8; 157.0; 146.1; 154.3; 147.6 | <0.05 sig |
| SECONDARY CGM % Time <70 mg/dl |
9.9; 8.9; 4.1; 9.9; 10.0; 10.5 | <0.05 sig |
| SECONDARY CGM % Time 70-180 mg/dl |
50.5; 58.9; 65.1; 64.0; 58.3; 62.0 | <0.05 sig |
| SECONDARY CGM % Time >180 mg/dl |
39.5; 32.3; 30.8; 26.0; 31.7; 27.6 | <0.05 sig |
| SECONDARY CGM - Coefficient of Variation (CV) |
30.6; 31.0; 28.2; 33.7; 39.9; 41.0 | <0.05 sig |
| SECONDARY CGM Fasting Blood Glucose (FBG) |
143; 137; 137; 140 | <0.05 sig |
| SECONDARY Liverpool Jet-Lag Questionnaire |
2.5; 4.1; 1.6; 3.8; 0.2; 0.2 | <0.01 sig |
| SECONDARY Sleep Quantity Measured by ActiGraph |
489; 398 | <0.05 sig |
| SECONDARY Sleep Efficiency Measured by ActiGraph |
92; 89 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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.
-
Exclusion Criteria
- 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.
-
Data sourced from ClinicalTrials.gov (NCT03668808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.