A Phase 4 interventional study of Insulin glargine U-300 in Type 1 Diabetes Mellitus, sponsored by Marmara University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Marmara University · Phase 4, Interventional, and Treatment
This study evaluated two different starting dose strategies when switching children and adolescents with type 1 diabetes from insulin glargine U-100 to insulin glargine U-300. Participants were randomly assigned to start insulin glargine U-300 either at the same basal insulin dose they had been using or at a 20% higher dose. Continuous glucose monitoring data were used to compare glucose control and hypoglycemia before and after the switch. Participants were also followed to evaluate longer-term changes in glucose control and insulin requirements
Insulin glargine U-300 has a more prolonged and stable pharmacokinetic and pharmacodynamic profile than insulin glargine U-100. However, the optimal initial dose when switching children and adolescents with type 1 diabetes from insulin glargine U-100 to U-300 has not been clearly established.
In this randomized study, participants were assigned to switch from insulin glargine U-100 to U-300 either at the same basal insulin dose or at a 20% higher initial dose. Continuous glucose monitoring data obtained before and after the switch were used to evaluate early changes in glycemic control, including time in range, time above range, and time below range, with particular attention to nighttime glucose control and hypoglycemia.
A subset of participants with adequate continuous glucose monitoring data was also followed at 3 and 6 months to evaluate longer-term glycemic outcomes, insulin requirements, and changes in anthropometric measures.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 71 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Marmara University is the lead sponsor of 590 studies on the registry; 135 are open to participants now.
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Participants switched from insulin glargine U-100 to insulin glargine U-300 at the same initial basal insulin dose.
Drug: Insulin glargine U-300
Participants switched from insulin glargine U-100 to insulin glargine U-300 at an initial basal insulin dose 20% higher than their previous insulin glargine U-100 dose.
Drug: Insulin glargine U-300
Insulin glargine U-300 was administered once daily as basal insulin. Participants switched from insulin glargine U-100 to insulin glargine U-300 using either the same basal insulin dose or an initial dose 20% higher than their previous U-100 dose, according to randomized group assignment. Subsequent dose adjustments were made according to glycemic control.
Early glycemic outcomes after switching from insulin glargine U-100 to U-300
Glycemic outcomes were assessed using continuous glucose monitoring (CGM) data during the 2 weeks before and 2 weeks after switching from insulin glargine U-100 to insulin glargine U-300. CGM metrics included time in range (70-180 mg/dL), time above range (\>180 and \>250 mg/dL), time below range (\<70 and \<54 mg/dL), mean sensor glucose, and coefficient of variation. Early glycemic outcomes were also compared between participants randomized to the same-dose and 20% higher initial dose strategies.
Time frame: 2 weeks before and 2 weeks after switching from insulin glargine U-100 to U-300
Long-term glycemic outcomes after switching to insulin glargine U-300
Glycemic control was evaluated at 3 and 6 months after switching from insulin glargine U-100 to insulin glargine U-300 using HbA1c and CGM-derived glycemic metrics, including time in range, time above range, time below range, mean sensor glucose, and coefficient of variation.
Time frame: Baseline, 3 months, and 6 months after switching to insulin glargine U-300
Plan to share: Undecided — De-identified individual participant data underlying the results reported in the published article may be made available upon reasonable request to the corresponding author, subject to institutional and ethical requirements.
Ran from May 2025 to primary completion in Nov 2025, 6 months.
Of 63 non-industry phase 4 interventional studies under Diabetes Mellitus, Type 1, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 43. This study's 6 months is below that.
Counting every sponsor, half of 74 studies reached it within 22 months; a quarter within 12 and three quarters within 38.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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