parallel randomized trial

EXENDA

A 24 Week Monocentric Prospective Randomized, Placebo-controlled Trial to Evaluate Efficacy of Combination of Exenatide and Dapagliflozin Compared to Dapagliflozin and Placebo and Its Effects on Hepatic, Myocardial and Pancreatic Fat Distribution in Patients With Uncontrolled Type 2 Diabetes Mellitus.

Type 2 diabetes (adults)NCT03007329S000796

Design

Randomized: 30
Start year: 2017
Treatment: 24 weeks, follow-up 28 weeks
Countries: Austria (1 sites)
Sponsor: Medical University of Vienna (industry)
Eligibility: age 18 to 75; BMI 25 or more; HbA1c 6.5 to 11 percent; metformin 1000 mg or more

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release 2 mg subcutaneous once weekly Exenatide QW plus dapagliflozin	metformin and dapagliflozin 10 mg daily; lifestyle: not reported	16	16
A2	Placebo Placebo plus dapagliflozin	metformin; dapagliflozin 10 mg daily; lifestyle: not reported	14	14

Baseline characteristics

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

Characteristic	Statistic	Exenatide extended release 2 mg subcutaneous once weekly A1	Placebo A2
age	mean (years)	59.4	60.9
age	sd (years)	8.5	7.4
bmi	mean (kg/m2)	31.9	30.7
bmi	sd (kg/m2)	4.6	3.5
diabetes duration	mean (years)	7.3	5.8
diabetes duration	sd (years)	5.2	4.7
female	n	6	4
female	percent	37.5	28.6
hba1c	mean (percent)	7.8	7.3
hba1c	sd (percent)	1.3	0.6
sbp	mean (mmHg)	137	131
sbp	sd (mmHg)	15	18
waist	mean (cm)	113.0	111.3
waist	sd (cm)	12.3	8.9
weight	mean (kg)	99.1	93.5
weight	sd (kg)	20.6	14.2
white	n	15	14
white	percent	93.8	100

Analyses this trial contributes to

Results

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	change	-17.8 mmol/mol	-24.8 to -10.8	16	not stated; randomized; R0025594:Table 3
24	A1 vs A2	md	-6.0 mmol/mol	-9.7 to -2.2		not stated; randomized; R0025594:Table 2
24	A1 vs A2	md	-0.52 percent	-0.86 to -0.17		not stated; randomized; R0025594:Table 2
24	A2	change	-6.9 mmol/mol	-10.5 to -3.3	14	not stated; randomized; R0025594:Table 3

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	change	-7.34 kg	-9.87 to -4.82	16	not stated; randomized; R0025594:Table 3
24	A1 vs A2	md	-2.32 kg	-5.84 to 1.21		not stated; randomized; R0025594:Table 2
24	A1 vs A2	md	-2.45 kg	-5.45 to 0.54		not stated; randomized; R0025594:Table 2
24	A2	change	-4.57 kg	-7.36 to -1.79	14	not stated; randomized; R0025594:Table 3

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 16	not stated; randomized; R0025594:Results
	A2	events				0 / 14	not stated; randomized; R0025594:Results

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	percent change	-7.5 percent	4.2		16	not stated; randomized; R0025594:Supplement S3
24	A2	percent change	-4.8 percent	4.9		14	not stated; randomized; R0025594:Supplement S3