crossover randomized trial

NCT00456300

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

The Role of Exenatide in Type 1 Diabetes Mellitus

Type 1 diabetes NCT00456300S002325

Design

Randomized
Start year: 2007
Treatment: 0.03 weeks
Countries: USA
Sponsor: Montefiore Medical Center (non industry)
Eligibility: age 13 to 22; type 1 diabetes 1 year or longer; BMI below 90th percentile; HbA1c below 8.5 percent

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	exenatide exenatide 1.25 ug single dose plus insulin	usual insulin with prandial bolus reduced by 20 percent; lifestyle: not reported		8
A2	exenatide exenatide 2.5 ug single dose plus insulin	usual insulin with prandial bolus reduced by 20 percent; lifestyle: not reported		8

Baseline characteristics

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

Characteristic	Statistic	Whole trial ALL
age	mean (years)	17
age	sd (years)	1
bmi	mean (kg/m2)	23.8
bmi	sd (kg/m2)	2.1
diabetes duration	mean (years)	5
diabetes duration	sd (years)	3.3
female	n	4
hba1c	mean (percent)	7.4
hba1c	sd (percent)	0.7
insulin dose	mean (units/kg/day)	0.9
insulin dose	sd (units/kg/day)	0.2
weight	mean (kg)	67
weight	sd (kg)	8.7

Results

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

Level 2 or 3 hypoglycemia (participants) (3 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	1 / 9	not stated; safety; registry:adverse_events
A1	events	1 / 8	not stated; completers; R0026856:Results
A2	events	0 / 9	not stated; safety; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 9	not stated; safety; registry:adverse_events
	A2	events				0 / 9	not stated; safety; registry:adverse_events

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 8	not stated; completers; R0026856:Results
	A2	events				2 / 8	not stated; completers; R0026856:Results

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 8	not stated; completers; R0026856:Results
	A2	events				0 / 8	not stated; completers; R0026856:Results