parallel randomized trial

NCT03829891

A Randomized, Open-label, Controlled,Parallel-group Study for Beinaglutide Versus Glargine Therapy in Glycemic Variability of Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT03829891S000676

Design

Randomized: 68
Start year: 2018
Treatment: 8 weeks, follow-up 16 weeks
Countries: China (3 sites)
Sponsor: Xijing Hospital (non industry)
Eligibility: age 18 to 70; diabetes 6 months or more on stable oral agents; HbA1c 7.5 to 11.0 percent; BMI 21 to 35

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: per protocol
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Beinaglutide 0.2 mg subcutaneous three times daily Beinaglutide 0.2 mg three times daily	stable oral glucose lowering drugs; lifestyle: not reported	35	29
A2	Insulin glargine Insulin glargine	stable oral glucose lowering drugs; lifestyle: not reported	33	30

Baseline characteristics

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

Characteristic	Statistic	Beinaglutide 0.2 mg subcutaneous three times daily A1	Insulin glargine A2
age	mean (years)	52.6	53.3
age	sd (years)	11.55	8.13
bmi	mean (kg/m2)	24.71	24.87
bmi	sd (kg/m2)	3.44	2.48
hba1c	mean (percent)	9.18	9.24
hba1c	sd (percent)	1.06	0.94
other male	n	23	26
other male	percent	65.7	78.8
sbp	mean (mmHg)	121.1	121.3
sbp	sd (mmHg)	13.61	12.47
waist	mean (cm)	89.93	93.58
waist	sd (cm)	9.87	6.82
weight	mean (kg)	69.73	72.36
weight	sd (kg)	14.45	10.57

Analyses this trial contributes to

Results

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
8	A1	change	-1.31 percent	-1.69 to -0.94	29	not stated; per protocol; R0007581:Table 3
8	A1 vs A2	md	0.33 percent	-0.09 to 0.75		not stated; per protocol; R0007581:Results
8	A2	change	-1.68 percent	-2.05 to -1.30	30	not stated; per protocol; R0007581:Table 3
16	A1	change	-1.35 percent	-1.91 to -0.79	29	not stated; per protocol; R0007581:Table 3
16	A2	change	-1.62 percent	-2.33 to -1.28	30	not stated; per protocol; R0007581:Table 3
16	A2 vs A1	md	-0.26 percent	-0.54 to 1.05		not stated; per protocol; R0007581:Results

Body weight change in kilograms (diabetes) (6 lines; O02)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
8	A1 vs A2	md	-2.25 kg	-3.32 to -1.22		not stated; per protocol; R0007581:Results
8	A1	change	-2.06 kg	-2.88 to -1.23	29	not stated; per protocol; R0007581:Table 3
8	A2	change	0.14 kg	-0.51 to 0.79	30	not stated; per protocol; R0007581:Table 3
16	A1	change	-2.62 kg	-3.91 to -1.34	29	not stated; per protocol; R0007581:Table 3
16	A2 vs A1	md	1.96 kg	0.51 to 3.41		not stated; per protocol; R0007581:Results
16	A2	change	-0.67 kg	-1.44 to 0.09	30	not stated; per protocol; R0007581:Table 3

HbA1c below 7 percent (4 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
8	A1	responders	24.14	29	not stated; per protocol; R0007581:Results
8	A2	responders	26.67	30	not stated; per protocol; R0007581:Results
16	A1	responders	34.48	29	not stated; per protocol; R0007581:Results
16	A2	responders	46.67	30	not stated; per protocol; R0007581:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 35	not stated; full analysis; R0007581:Results
	A2	events				9 / 33	not stated; full analysis; R0007581:Results

Systolic blood pressure change (6 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
8	A1 vs A2	md	-1.70 mmHg	-6.25 to 2.85		not stated; per protocol; R0007581:Results
8	A1	change	-6.21 mmHg	-11.49 to -0.92	29	not stated; per protocol; R0007581:Table 3
8	A2	change	-3.53 mmHg	-8.87 to 1.81	30	not stated; per protocol; R0007581:Table 3
16	A1 vs A2	md	-4.15 mmHg	-9.60 to 1.31		not stated; per protocol; R0007581:Results
16	A1	change	-7.00 mmHg	-14.10 to 0.10	29	not stated; per protocol; R0007581:Table 3
16	A2	change	-3.68 mmHg	-9.30 to 1.93	30	not stated; per protocol; R0007581:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 35	not stated; full analysis; R0007581:Results
	A2	events				0 / 33	not stated; full analysis; R0007581:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 35	not stated; full analysis; R0007581:Results
	A2	events				1 / 33	not stated; full analysis; R0007581:Results