NCT04623086: GLIDING

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

Completed Phase 4 Results posted Last updated 28 February 2024

What this trial tests

Phase 4 trial testing Insulin Degludec in Type 1 Diabetes in 59 participants. Completed in 31 December 2023.

Timeline

14 February 2020

Primary endpoint
7 September 2022

31 December 2023

Quick facts

Lead sponsor	University of Washington
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	59
Start date	14 February 2020
Primary completion	7 September 2022
Estimated completion	31 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Insulin Degludec (INSULIN DEGLUDEC) — full drug profile →
• Insulin Glargine (INSULIN GLARGINE) — full drug profile →
• Placebo

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

University of Washington

Who can join

Adults 18 to 75, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in Percent Time in Range Primary · 48 hours prior to 48 hours after 1st dose of degludec insulin

Change in percent time spent in target glycemic range (TIR, glucose 70-180 mg/dL, both values included) in the 48 hours before and the 48 hours after the 1st dose of IDeg.

Group	Value	95% CI
Insulin Glargine and Insulin Degludec	2	± 14.7
Insulin Degludec and Placebo	-6.1	± 17.6

Coefficient of Variation (CV) of Percent-time-in-range Secondary · 48 hours prior to 48 hours after 1st dose of degludec insulin

Change in coefficient of variation of glucose (CV) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)

Group	Value	95% CI
Insulin Glargine and Insulin Degludec	3	± 6.9
Insulin Degludec and Placebo	-1.1	± 8.5

Nocturnal Percent Time in Range of 70-180 mg/dL Nocturnal Time in Range (N-TIR) Secondary · 4 days: Outcome Measure Time Frame 48 hours prior to 48 hours after 1st dose of degludec insulin

Change in nocturnal (defined as midnight to 0600 hours) time in range (glucose in 70-180 mg/dL range) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)

Group	Value	95% CI
Insulin Glargine and Insulin Degludec	5.1	± 34.6
Insulin Degludec and Placebo	-7	± 34.2

Percent Time Above 180 mg/dL (TAR-1) Secondary · 4 days

Change in time above range (glucose in 181-250 mg/dL range, TAR-1) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)

Group	Value	95% CI
Insulin Glargine and Insulin Degludec	5.4	± 15.4
Insulin Degludec and Placebo	6.5	± 12.4

Time Above Range-2 (TAR-2) Secondary · 4 days

Change in time above range (glucose above 250 mg/dL range, TAR-2) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)

Group	Value	95% CI
Insulin Glargine and Insulin Degludec	2.2	± 6.8
Insulin Degludec and Placebo	1.9	± 6.2

Time Below Range-1 (TBR-1) Secondary · 48 hours prior to 48 hours after 1st dose of degludec insulin

Change in time below range (glucose 54-70 mg/dL range, TBR-1) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)

Group	Value	95% CI
Insulin Glargine and Insulin Degludec	1.1	± 3.5
Insulin Degludec and Placebo	-1.5	± 3.4

Time Below Range-2 (TBR-2) Secondary · 48 hours prior to 48 hours after 1st dose of degludec insulin

Change in time below range (glucose below 54 mg/dL range, TBR-2) in the 48 hours before and the 48 hours after the 1st dose of IDeg, as noted on study continuous glucose monitor (dexcom G6)

Group	Value	95% CI
Insulin Glargine and Insulin Degludec	0.3	± 0.7
Insulin Degludec and Placebo	-0.8	± 4.2

Correction Boluses Secondary · 48 hours prior to 48 hours after 1st dose of degludec insulin

Change in the number of daily correction boluses administered in the 48 hours before and 48 hours after the 1st dose of degludec insulin, as noted on insulin logs maintained by participants

Group	Value	95% CI
Insulin Glargine and Insulin Degludec	0	± 1.0
Insulin Degludec and Placebo	0	± 1.6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.