parallel randomized trial

NCT07370922

Glucagon-Like Peptide 1 Receptor Agonist in Diabetes Mellitus Management in Children and Adolescents With Transfusion-Dependent Thalassemia

Design

Randomized: 80
Start year: 2024
Treatment: 24 weeks, follow-up 24 weeks
Countries: Egypt (1 sites)
Sponsor: Ain Shams University (non industry)
Eligibility: age 10 to 18; transfusion dependent thalassemia induced diabetes uncontrolled on metformin

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Dulaglutide 0.75 mg subcutaneous once weekly Dulaglutide 0.75 mg weekly	deferasirox chelation; lifestyle: none	40	40
A2	Basal bolus insulin Basal bolus insulin	deferasirox chelation; lifestyle: none	40	40

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Dulaglutide 0.75 mg subcutaneous once weekly A1	Basal bolus insulin A2	Whole trial ALL
age	mean (years)			12.25
age	sd (years)			1.33
bmi sds	median	-0.23	0.26
bmi sds	q1	-0.45	-0.15
bmi sds	q3	0.37	0.59
diabetes duration	mean (years)			7.59
diabetes duration	sd (years)			1.79
egfr	mean (mL/min/1.73 m2)	105.88	104.62
egfr	sd (mL/min/1.73 m2)	9.11	8.09
female	n			30
female	percent			37.5
hba1c	mean (percent)	8.54	8.97
hba1c	sd (percent)	1.06	1.52
sbp	mean (mmHg)	103.32	102.11
sbp	sd (mmHg)	7.86	7.51
uacr	mean (mg/mmol)	1.35	1.43
uacr	sd (mg/mmol)	0.18	0.19

7 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 40	not stated; randomized; R0001986:Abstract
	A2	events				0 / 40	not stated; randomized; R0001986:Abstract

Discontinuation due to adverse events (1 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 40	not stated; randomized; R0001986:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				10 / 40	not stated; randomized; gastrointestinal manifestations; R0001986:Results
	A2	events				4 / 40	not stated; randomized; gastrointestinal manifestations; R0001986:Results

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 40	not stated; randomized; R0001986:Results
	A2	events				0 / 40	not stated; randomized; R0001986:Results