Phase 4
N=47
Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04623086 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Mean Change in Percent Time in Range — 2; -6.1 percentage of time in measured period — p=0.14
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin Degludec (Drug); Insulin Glargine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Percent Time in Range |
2; -6.1 | 0.14 |
| SECONDARY Coefficient of Variation (CV) of Percent-time-in-range |
3; -1.1 | 0.11 |
| SECONDARY Nocturnal Percent Time in Range of 70-180 mg/dL Nocturnal Time in Range (N-TIR) |
5.1; -7 | 0.29 |
| SECONDARY Percent Time Above 180 mg/dL (TAR-1) |
5.4; 6.5 | 0.015 sig |
| SECONDARY Time Above Range-2 (TAR-2) |
2.2; 1.9 | 0.88 |
| SECONDARY Time Below Range-1 (TBR-1) |
1.1; -1.5 | 0.031 sig |
| SECONDARY Time Below Range-2 (TBR-2) |
0.3; -0.8 | 0.27 |
| SECONDARY Correction Boluses |
0; 0 | >0.99 |
Summary
This study evaluates direct switching vs use of a bridging dose from insulin glargine to insulin degludec in type 1 DM patients. Half of the participants will receive a bridging insulin glargine dose along with the 1st dose of degludec, while other half will receive a placebo and 1st dose of degludec.
Eligibility Criteria
Inclusion Criteria
- Patients must meet ALL inclusion criteria to be included in the study.
- Patient age is 18-75 years.
- Diagnosis of T1D of at least 1-year duration.
- Has the ability to provide informed consent before any trial-related activities.
- Treated with insulin glargine as their basal insulin in the 3 months preceding screening visit.
- Stable insulin regimen (defined as change of <20% in the total daily dose of insulin and no change to the basal insulin agent) over the 3 months preceding the screening visit.
- Patient willing to dose their basal insulin at bedtime.
- Hemoglobin A1c < 9% in the 3 months preceding screening visit.
- Able to self-administer their insulin doses.
- Able to do self-monitoring of blood glucose using a glucose meter and willing to do this at least 2 times daily for patients using a CGM that requires calibration prior to the study and 4 times daily for patients who were not using a CGM prior to the study.
- Agreeable to the use of a continuous glucose monitor (CGM) for the duration required in the study. If already using a CGM prior to the study, then agreeable to wearing the blinded study CGM concurrently during the study period.
- Will be reachable by phone and/or email to comply with study procedures.
- Will be able to comply with study procedures, per investigator's opinion.
- Patient agrees to not use correctional insulin unless BG ≥250 for the 48 hours before and after 1st dose of IDeg.
Exclusion Criteria
- Patient must not have ANY of the exclusion criteria to be included in the study.
- Patients with eGFR <30 on at least 2 measurements within 1-year of the screening visit.
- History of myocardial infarction within 6 months preceding the screening visit.
- Patients taking non-insulin medications for the glycemic management of T1D (including metformin, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors, thiazolidinediones, alpha-glucosidase inhibitors, pramlintide)
- Known or suspected allergy to IDeg or one of its excipients.
- Pregnant, planning to become pregnant in the next 3 months or breastfeeding.
- Participation in a clinical trial with investigational drug within 1 month of the screening visit or at present.
- Skin condition that prevents the insertion of the CGM.
- Previously randomized and received drug in this study.
- Presence of decompensated or poorly controlled psychiatric conditions.
- Current known or suspected illicit substance use.
- Any anticipated surgery or procedure in the next 14 days.
- Patients using U-300 glargine as their basal insulin.
- Patients using insulin afrezza as their short-acting insulin.
- Use of glucocorticoid burst/pulse therapy within 14 days prior to screening visit (chronic stable glucocorticoid doses are acceptable).
Data sourced from ClinicalTrials.gov (NCT04623086). 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.