parallel randomized trial

S002952

Design

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Polyethylene glycol loxenatide 0.2 mg subcutaneous once weekly PEG-loxenatide 0.2 mg weekly plus metformin and insulin	metformin 1.5 to 2.0 g daily; premeal insulin three times daily from 12 U per day, adjusted to glucose; lifestyle: standard	50	50
A2	Standard care or no added treatment Metformin plus insulin (control)	metformin 1.5 to 2.0 g daily; premeal insulin three times daily from 12 U per day, adjusted to glucose; lifestyle: standard	50	50

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

Characteristic	Statistic	Polyethylene glycol loxenatide 0.2 mg subcutaneous once weekly A1	Standard care or no added treatment A2
age	mean (years)	51.38	51.49
age	sd (years)	6.39	6.67
bmi	median (kg/m2)	28.50	27.40
bmi	q1 (kg/m2)	25.25	24.88
bmi	q3 (kg/m2)	30.10	29.05
diabetes duration	mean (years)	3.65	3.77
diabetes duration	sd (years)	1.28	1.32
female	n	24	23
hba1c	median (percent)	7.60	7.60
hba1c	q1 (percent)	6.90	6.90
hba1c	q3 (percent)	8.13	8.13
weight	median (kg)	82.50	81.50
weight	q1 (kg)	75.00	75.75
weight	q3 (kg)	87.50	86.00

18 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
26.07	A1	final	percent			50	not stated; randomized; R0007813:Table II
26.07	A2	final	percent			50	not stated; randomized; R0007813:Table II

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26.07	A1	final	kg			50	not stated; randomized; R0007813:Table II
26.07	A2	final	kg			50	not stated; randomized; R0007813:Table II

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 50	not stated; randomized; R0007813:Table I
A1	events	0 / 50	not stated; randomized; R0007813:Table I
A1	events	0 / 50	not stated; randomized; R0007813:Table I
A2	events	0 / 50	not stated; randomized; R0007813:Table I
A2	events	0 / 50	not stated; randomized; R0007813:Table I
A2	events	0 / 50	not stated; randomized; R0007813:Table I

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 50	not stated; safety; R0007813:Results
	A2	events				0 / 50	not stated; safety; R0007813:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 50	not stated; randomized; R0007813:Table I
	A2	events				1 / 50	not stated; randomized; R0007813:Table I

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 50	not stated; safety; R0007813:Results
	A2	events				0 / 50	not stated; safety; R0007813:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 50	not stated; randomized; pancreatitis; R0007813:Table I
	A2	events				0 / 50	not stated; randomized; pancreatitis; R0007813:Table I