Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Patients must meet ALL inclusion criteria to be included in the study.

1. Patient age is 18-75 years.

2. Diagnosis of T1D of at least 1-year duration.

3. Has the ability to provide informed consent before any trial-related activities.

4. Treated with insulin glargine as their basal insulin in the 3 months preceding screening visit.

5. 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.

6. Patient willing to dose their basal insulin at bedtime.

7. Hemoglobin A1c < 9% in the 3 months preceding screening visit.

8. Able to self-administer their insulin doses.

9. 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.

10. 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.

11. Will be reachable by phone and/or email to comply with study procedures.

12. Will be able to comply with study procedures, per investigator's opinion.

13. 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.

1. Patients with eGFR <30 on at least 2 measurements within 1-year of the screening visit.

2. History of myocardial infarction within 6 months preceding the screening visit.

3. 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)

4. Known or suspected allergy to IDeg or one of its excipients.

5. Pregnant, planning to become pregnant in the next 3 months or breastfeeding.

6. Participation in a clinical trial with investigational drug within 1 month of the screening visit or at present.

7. Skin condition that prevents the insertion of the CGM.

8. Previously randomized and received drug in this study.

9. Presence of decompensated or poorly controlled psychiatric conditions.

10. Current known or suspected illicit substance use.

11. Any anticipated surgery or procedure in the next 14 days.

12. Patients using U-300 glargine as their basal insulin.

13. Patients using insulin afrezza as their short-acting insulin.

14. Use of glucocorticoid burst/pulse therapy within 14 days prior to screening visit (chronic stable glucocorticoid doses are acceptable).