parallel randomized trial

S003429

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Type 2 diabetes (adults)S003429

Design

Randomized: 34
Start year: 2011
Treatment: 26 weeks, follow-up 26 weeks
Countries: Turkey (1 sites)
Sponsor: (non industry)
Eligibility: age 40 to 70; HbA1c 7 to 9.5 percent; BMI 25 to 45; metformin 2 g daily; insulin and incretin naive

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide (group E)	metformin 2 g/day; lifestyle: not reported
A2	Insulin glargine Insulin glargine (group I)	metformin 2 g/day; lifestyle: not reported

Baseline characteristics

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

Characteristic	Statistic	Exenatide 10 ug subcutaneous twice daily A1	Insulin glargine A2
age	mean (years)	52.18	53.12
age	sd (years)	7.26	6.99
bmi	mean (kg/m2)	35.89	33.21
bmi	sd (kg/m2)	3.7	4.45
diabetes duration	mean (years)	6.88	7.59
diabetes duration	sd (years)	3.26	4.26
female	n	12	10
female	percent	70.6	58.8
hba1c	mean (percent)	7.95	8.11
hba1c	sd (percent)	0.81	0.76
other coronary artery disease	n	2	1
other coronary artery disease	percent	12	6
sbp	median (mmHg)	140	130
sbp	q1 (mmHg)	130	120
sbp	q3 (mmHg)	150	150
waist	mean (cm)	112.47	107.41
waist	sd (cm)	10.35	11.41
weight	mean (kg)	94.34	90.51
weight	sd (kg)	11.77	14.32

Results

14 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	A1	final	6.73 percent	0.75			not stated; other; R0040568:Table 1
26	A2	final	6.68 percent	0.83			not stated; other; R0040568:Table 1

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Detail
26	A1	change	-5.55 kg		not stated; other; R0040568:Discussion
26	A1	final	88.79 kg	12.94	not stated; other; R0040568:Table 1
26	A2	change	-0.85 kg		not stated; other; R0040568:Discussion
26	A2	final	89.66 kg	14.43	not stated; other; R0040568:Table 1

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	Detail
26	A1	final	mmHg	not stated; other; R0040568:Table 4
26	A1	percent change	percent	not stated; other; R0040568:Table 4
26	A2	final	mmHg	not stated; other; R0040568:Table 4
26	A2	percent change	percent	not stated; other; R0040568:Table 4

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0040568:Materials and Methods
	A2	events				0 /	not stated; other; R0040568:Materials and Methods

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0040568:Discussion
	A2	events				0 /	not stated; other; R0040568:Discussion