crossover randomized trial

Lixi

Effects of Lixisenatide on Gastric Emptying, Glycaemia and 'Postprandial' Blood Pressure in Type 2 Diabetes and Healthy Subjects.

Design

Randomized
Start year: 2013
Treatment
Countries: Australia (1 sites)
Sponsor: Royal Adelaide Hospital (industry)
Eligibility: age 40 to 80; BMI 19 to 35; T2D on diet or metformin with HbA1c below 8.5 percent, or healthy

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	lixisenatide Lixisenatide 10 ug single dose	lifestyle: not reported
A2	Placebo Placebo	lifestyle: not reported

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

Characteristic	Statistic	Whole trial ALL
age diabetes:none	mean (years)	67.2
age diabetes:none	se (years)	2.3
age diabetes:t2d	mean (years)	61.9
age diabetes:t2d	se (years)	2.3
bmi diabetes:none	mean (kg/m2)	25.4
bmi diabetes:none	se (kg/m2)	0.8
bmi diabetes:t2d	mean (kg/m2)	30.3
bmi diabetes:t2d	se (kg/m2)	0.7
diabetes duration diabetes:t2d	mean (years)	5.3
diabetes duration diabetes:t2d	se (years)	1.2
female diabetes:none	n	6
female diabetes:t2d	n	6
hba1c diabetes:t2d	mean (percent)	6.9
hba1c diabetes:t2d	se (percent)	0.2
metformin use diabetes:t2d	n	10

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

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	2 / 18	not stated; other; diabetes:none; nausea; R0010615:Methods
A1	events	0 / 16	not stated; other; diabetes:t2d; R0010615:Methods
A2	events	0 / 18	not stated; other; diabetes:none; R0010615:Methods
A2	events	0 / 16	not stated; other; diabetes:t2d; R0010615:Methods

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	2 / 18	not stated; other; diabetes:none; nausea; R0010615:Methods
A1	events	0 / 16	not stated; other; diabetes:t2d; R0010615:Methods
A2	events	0 / 16	not stated; other; diabetes:t2d; R0010615:Methods
A2	events	0 / 18	not stated; other; diabetes:none; R0010615:Methods