Table 2.

Clinical trials of GLP1 receptor agonists, DPP4 inhibitors, and SGLT2 inhibitors in children and adolescents with type 1 diabetes. List of all ongoing (in italics) and completed trials of GLP1 receptor agonists, DPP4 inhibitors, and SGLT2 inhibitors in children and adolescents < 18 years in the USA. Participant numbers listed in parentheses indicate target enrollment numbers for ongoing trials

Drug class	Major side effects	Experimental drug	Design	Ph	N	Duration	Primary and secondary outcomes	Mortality and SAE	Results
GLP1 receptor agonists	Nausea, vomiting and diarrhea Injection site reactions	Exenatide NCT01269034	Randomized Open label	4	14	1d per treatment (× 3)	1) Postprandial hyperglycemia 2) Postprandial glucagon and gastric emptying	Not available	Completed: 2017 Results: not published
		NCT01269047	Randomized Open label	4	37	16 wk	1) Postprandial blood glucose 2) Difference in HbA1c between control and treatment groups	Mortality: none SAE: none	Completed: 2016 Results: NCT01269047
		NCT00456300	Randomized Double blind	2	9	1d per treatment (× 3)	1) Mean postprandial plasma glucose AUC	Mortality: none SAE: none	Completed: 2009 Results: [74]
		Liraglutide NCT02516657	Non-randomized Open label	3	(15)	2 wk	1) Mean weekly blood glucose 2) TDID, blood glucose, amylase	Ongoing study	Estimated completion: 2021
DPP4 inhibitors	Upper respiratory tract infections Urinary tract infections Arthralgias	Sitagliptin NCT01718093	Randomized Open label	4	21	6 wk	1) Glucose concentration and AUC	Not available	Completed: 2015 Results: not published
		NCT01155284	Randomized Triple blind	2	68	12 mo	1) 2 h C-peptide AUC at month 12 2) 2 h C-peptide AUC at month 6	Mortality: none SAE: sitagliptin 2/46, placebo 1/22	Completed: 2015 Results: [75]
SGLT2 inhibitors	Normoglycemic ketoacidosis Volume depletion Genital infections	Dapagliflozin NCT04333823	Randomized quadruple blind	3	(100)	16 wk	1) Change in mGFR from baseline to wk 16 2) HbA1c, AE, glycemic control, weight, TDID	Ongoing study	Estimated completion: 2023

AE, adverse events; AUC, area under the curve; d, days; h, hours; mGFR, measured glomerular filtration rate; mo, months; Ph, phase; SAE, serious adverse events; TDID, total daily insulin dose; wk, weeks