parallel randomized trial

NCT02803918

Randomized, Double-blind, Placebo-controlled, Dose Escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin and/or Basal Insulin

Children and adolescents with type 2 diabetes NCT02803918S000673

Design

Randomized: 23
Start year: 2017
Treatment: 6 weeks, follow-up 6.43 weeks
Countries: United States, Spain, Mexico, Mauritius, South Africa, Turkey (11 sites)
Sponsor: Sanofi (industry)
Eligibility: Age 10 to 17; T2D on metformin and/or basal insulin; HbA1c above 6.5 to 11 percent; BMI above 85th percentile

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: safety
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Lixisenatide 20 ug subcutaneous once daily Lixisenatide	metformin and or basal insulin; lifestyle: standard	18	18
A2	Placebo Placebo	metformin and/or basal insulin; lifestyle: standard	5	5

Baseline characteristics

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

Characteristic	Statistic	Lixisenatide 20 ug subcutaneous once daily A1	Placebo A2
age	mean (years)	15.6	15.4
age	sd (years)	1.0	1.5
asian	n	0	0
black	n	4	0
bmi	mean (kg/m2)	33.2	37.4
bmi	sd (kg/m2)	4.8	3.6
diabetes duration	mean (years)	1.6	3.5
diabetes duration	sd (years)	1.2	2.2
female	n	13	3
female	percent	72.2	60.0
hba1c	mean (percent)	8.16	8.14
hba1c	sd (percent)	0.93	1.58
other background: basal insulin only	n	1	0
other background: metformin only	n	13	3
other background: metformin plus basal insulin	n	4	2
weight	mean (kg)	91.3	98.0
weight	sd (kg)	18.8	14.7
white	n	12	4

Analyses this trial contributes to

Results

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

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
6	A1	change	-0.3 percent	1.2		18	not stated; other; R0009184:Table 3
6	A2	change	0.1 percent	1.1		5	not stated; other; R0009184:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 18	not stated; safety; R0009184:Table 4
	A2	events				0 / 5	not stated; safety; R0009184:Table 4

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 18	not stated; safety; R0009184:Table 4
	A2	events				0 / 5	not stated; safety; R0009184:Table 4

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 18	not stated; safety; R0009184:Table 4
	A2	events				1 / 5	not stated; safety; R0009184:Table 4

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 18	not stated; safety; R0009184:Table 4
	A2	events				0 / 5	not stated; safety; R0009184:Table 4