Table 3.

Ongoing clinical trials.

Clinical Trials.gov Identifier	Study Design	Study Population/ Study Duration	Intervention/ Treatment	Locations	Primary Endpoint	Secondary Endpoint
NCT04075513 [44]	Randomized, controlled trial	338/ 12 weeks	• Gla-300 • IDeg-100	US, Brazil, Germany, Hungary, UK	To demonstrate the noninferiority of insulin Gla-300 compare to insulin IDeg-100 on glycemic control and variability	• To evaluate the glycemic control and variability parameters in each treatment group at week-12 CGM • Safety of insulin Gla-300 vs. IDeg-100
NCT03107208 [45]	Randomized, open label	Up to 1 week following episode of diabetic ketoacidosis.	• Gla-100	US	Rate of rebound hyperglycemia	• Rate of recurrent ketogenesis • Risk of hypoglycemia between those given early administration of glargine vs. those given standard-of-care management. • Evaluation of CGM and POC glucose monitoring during DKA treatment in children.
NCT03952130 [46]	Prospective, randomized, double-blind	350/ 26 weeks	• LY900014 + Glargine/IDeg-100 • Insulin lispro+ Glargine/IDeg-100	Argentina, China, Mexico	Change from baseline in HbA1c	• 1-hour PPG excursion during Mixed-Meal Tolerance Test • Rate of severe hypoglycemia
NCT03400501 [47]	Randomized	30/ 4 months	• IDeg-100 • Glargine	US	Lower beta hydroxybutyrate levels (Hypothesis: beta hydroxybutyrate levels will be lower in the morning (≥0.6 mmol/L) of the first day of the school week in subjects receiving IDeg, since the long half-life of IDeg will compensate for missed insulin doses over the weekend/holidays)	• Control of HbA1c levels • Measure of beta hydroxybutyrate levels between the 2 groups (Differences in frequency of elevated beta hydroxybutyrate levels when receiving supervised injections of basal insulin vs. when not receiving supervised injections).

Abbreviations: CGM, continuous glucose monitoring; DKA, diabetic ketoacidosis; Gla-300, glargine 300 U/mL; HbA1c, glycated hemoglobin; IDeg-100, insulin degludec 100 U/mL; POC, point-of-care; PPG, post-prandial glucose.