crossover randomized trial

S003038

Design

Randomized: 27
Start year: 2014
Treatment: 4 weeks
Countries: United Kingdom (1 sites)
Sponsor: University of Oxford (mixed)
Eligibility: type 1 diabetes on insulin; numeric inclusion ranges not printed

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Lixisenatide 20 ug subcutaneous once daily Lixisenatide	usual insulin, reduced at start then titrated to glucose 6 to 9 mmol/L; lifestyle: none	27	25
A2	Placebo Placebo	usual insulin, reduced at start then titrated to glucose 6 to 9 mmol/L; lifestyle: none	27	25

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	Whole trial ALL
age	mean (years)			44
age	sd (years)			2.5
bmi	mean (kg/m2)	27.0	27.1
bmi	sd (kg/m2)	3.5	3.5
diabetes duration	mean (years)			18.6
diabetes duration	sd (years)			14.2
egfr	mean (mL/min/1.73 m2)			84.58
egfr	sd (mL/min/1.73 m2)			11.3
female	n			13
hba1c	mean (percent)	7.9	7.9
hba1c	sd (percent)	0.5	0.5
insulin dose: basal	mean (U/day)			27.32
insulin dose: basal	sd (U/day)			15.1
insulin dose: prandial	mean (U/day)			18.28
insulin dose: prandial	sd (U/day)			14.3
weight	mean (kg)	78.8	79.0
weight	sd (kg)	11.1	11.2

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Detail
4	A1	change	0.07 percent	0.3	not stated; other; R0019632:Table 2
4	A1	final	8.1 percent	1.0	not stated; other; R0019632:Table 2
4	A2	change	0.03 percent	0.4	not stated; other; R0019632:Table 2
4	A2	final	8.0 percent	0.5	not stated; other; R0019632:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; other; R0019632:Results
	A2	events				0 / 27	not stated; other; R0019632:Results

Level 2 or 3 hypoglycemia (episode rate) (2 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate					not stated; other; R0019632:Table 3
	A2	rate					not stated; other; R0019632:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; other; R0019632:Results
	A2	events				1 / 27	not stated; other; R0019632:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; other; R0019632:Results
	A2	events				0 / 27	not stated; other; R0019632: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 / 27	not stated; other; R0019632:Results
	A2	events				0 / 27	not stated; other; R0019632:Results

Diabetic ketoacidosis (2 lines; O30)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; other; R0019632:Results
	A2	events				0 / 27	not stated; other; R0019632:Results

Severe hypoglycemia (type 1 diabetes) (2 lines; O31)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; other; R0019632:Results
	A2	events				0 / 27	not stated; other; R0019632:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 27	not stated; other; R0019632:Results
	A2	events				0 / 27	not stated; other; R0019632:Results