parallel randomized trial

NCT02449603

Comparison of Exenatide vs. Biphasic Insulin Aspart 30 on Glucose Variability in Type 2 Diabetes : a Randomised Open Parallel-controlled Study

Design

Randomized: 104
Start year: 2015
Treatment: 16 weeks, follow-up 16 weeks
Countries: China (6 sites)
Sponsor: Xijing Hospital (mixed)
Eligibility: age 18 to 70, HbA1c 7.5 to 10.0 percent on metformin at least 1500 mg, BMI 21 to 35

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide	metformin 1500 mg per day; lifestyle: not reported		52
A2	Premixed insulin Biphasic insulin aspart 30	metformin 1500 mg per day; lifestyle: not reported		52

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

Characteristic	Statistic	Exenatide 10 ug subcutaneous twice daily A1	Premixed insulin A2
age	mean (years)	51.54	51.61
age	sd (years)	9.85	9.77
bmi	mean (kg/m2)	26.27	26.25
bmi	sd (kg/m2)	3.08	3.12
diabetes duration	mean (years)	5.96	6.09
diabetes duration	sd (years)	4.15	4.46
hba1c	mean (percent)	8.75	8.81
hba1c	sd (percent)	0.74	0.74
other male	n	36	35
other male	percent	69.23	67.37
other urinary albumin	max (mg/L)	1110	2930
other urinary albumin	median (mg/L)	11.9	18.4
other urinary albumin	min (mg/L)	2.1	2.1
sbp	mean (mmHg)	123.27	123.00
sbp	sd (mmHg)	10.81	12.34
weight	mean (kg)	74.09	73.56
weight	sd (kg)	11.22	12.00

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1	change	-1.38 percent	-1.89 to -0.86	52	not stated; full analysis; R0023224:Results
16	A2	change	-1.74 percent	-2.20 to -1.28	52	not stated; full analysis; R0023224:Results
16	A2 vs A1	md	-0.36 percent	-0.87 to 0.14		not stated; full analysis; R0023224:Results

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1	change	-2.38 kg	-3.34 to -1.41	52	not stated; full analysis; R0023224:Results
16	A2	change	0.89 kg	0.02 to 1.76	52	not stated; full analysis; R0023224:Results
16	A2 vs A1	md	3.27 kg	2.32 to 4.22		not stated; full analysis; R0023224:Results

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

Arm	Statistic	Estimate	Events / N	Detail
A1	events		0 / 52	not stated; safety; R0023224:Abstract
A1	events		10 / 52	not stated; safety; R0023224:Table 3
A1	events	5.77	52	not stated; safety; R0023224:Abstract
A2	events	17.31	52	not stated; safety; R0023224:Abstract
A2	events		0 / 52	not stated; safety; R0023224:Abstract
A2	events		19 / 52	not stated; safety; R0023224:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 52	not stated; safety; R0023224:Table 3
	A2	events				3 / 52	not stated; safety; R0023224:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 52	not stated; safety; R0023224:Results
	A2	events				1 / 52	not stated; safety; R0023224:Results

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 52	not stated; safety; R0023224:Table 3
	A2	events				0 / 52	not stated; safety; R0023224:Table 3