crossover randomized trial

NCT02049034

The Effect of Lixisenatide on Postprandial Lipid and Glucose Metabolism in Patients with Type 2 Diabetes

Design

Randomized
Start year: 2014
Treatment: 4 weeks, follow-up 12 weeks
Countries: United Kingdom (1 sites)
Sponsor: University of Surrey (industry)
Eligibility: white men 40 to 65; type 2 diabetes on metformin monotherapy; HbA1c 7.5 to 9.5 percent

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Lixisenatide 20 ug subcutaneous once daily Lixisenatide	metformin; lifestyle: not reported		8
A2	Placebo Placebo	metformin; lifestyle: not reported		8

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)			57.3
age	se (years)			1.9
bmi	mean (kg/m2)			30.3
bmi	se (kg/m2)			1.0
hba1c	mean (percent)			8.2
hba1c	se (percent)			0.3
other male	n			8
weight	mean (kg)	91.8	92.2
weight	se (kg)	3.4	2.9

12 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
4	A1	final	7.2 percent	0.3			not stated; other; R0018624:Table 1
4	A2	final	7.9 percent	0.3			not stated; other; R0018624:Table 1

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
4	A1	final	89.4 kg	3.3			not stated; other; R0018624:Table 1
4	A2	final	90.7 kg	3.1			not stated; other; R0018624:Table 1

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 8	not stated; other; R0018624:Results
	A2	events				0 / 8	not stated; other; R0018624:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 8	not stated; other; R0018624:Results
	A2	events				0 / 8	not stated; other; R0018624:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 8	not stated; other; R0018624:Results
	A2	events				0 / 8	not stated; other; R0018624:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 8	not stated; other; R0018624:Results
	A2	events				0 / 8	not stated; other; R0018624:Results