parallel randomized trial

Dapalost

A 24-week, Single Centre, Randomized, Parallel-group, Double-blind, Placebo Controlled Phase II Study With an Optional 28-week Open-label Extension to Evaluate the Efficacy on Body Weight of Dapagliflozin 10 mg Once Daily in Combination With Exenatide 2 mg Once Weekly in Obese Non-diabetic Subjects.

Overweight or obesity without diabetes (adults)NCT02313220S001235

Design

Randomized: 50
Start year: 2014
Treatment: 24 weeks, follow-up 24 weeks
Countries: Sweden (1 sites)
Sponsor: Uppsala University (industry)
Eligibility: age 18 to 70; BMI 30 to 45 kg/m2; no diabetes

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release and dapagliflozin 2 to 10 mg injection once weekly Dapagliflozin 10 mg once daily plus exenatide 2 mg once weekly	lifestyle: standard	25	25	23
A2	Placebo Placebo oral tablet plus placebo injection	lifestyle: standard	25	24	20

Baseline characteristics

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

Characteristic	Statistic	Exenatide extended release and dapagliflozin 2 to 10 mg injection once weekly A1	Placebo A2
age	mean (years)	53.5	50.0
age	sd (years)	13.5	11.8
bmi	mean (kg/m2)	35.8	35.0
bmi	sd (kg/m2)	2.9	3.7
egfr	mean (mL/min/1.73 m2)	85.0	84.6
egfr	sd (mL/min/1.73 m2)	17.3	12.1
female	n	15	15
female	percent	60.0	62.5
hba1c	mean (percent)	5.6	5.6
hba1c	sd (percent)	0.35	0.30
sbp	mean (mmHg)	133.7	133.8
sbp	sd (mmHg)	12.7	17.5
waist	mean (cm)	117.6	114.4
waist	sd (cm)	11.3	12.6
weight	mean (kg)	106.43	102.72
weight	sd (kg)	15.55	17.26

Analyses this trial contributes to

Results

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

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Detail
24	A1	change	-9.8 mmHg	-13.7 to -5.8	not stated; full analysis; R0025222:Table 1
24	A1	change	-9.6 mmHg	-13.6 to -5.7	not stated; full analysis; R0025627:Table 2
24	A1 vs A2	md	-6.7 mmHg	-12.4 to -1.0	not stated; full analysis; R0025627:Table 2
24	A2	change	-3.1 mmHg	-7.2 to 1.1	not stated; full analysis; R0025222:Table 1
24	A2	change	-3.0 mmHg	-7.1 to 1.2	not stated; full analysis; R0025627:Table 2

Percent body weight change (5 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Detail
24	A1	percent change	-4.47 percent	-6.05 to -2.90	not stated; full analysis; R0025222:Table 1
24	A1	percent change	-4.47 percent	-6.04 to -2.89	not stated; full analysis; R0025627:Table 2
24	A1 vs A2	md	-4.19 percent	-6.47 to -1.92	not stated; full analysis; R0025627:Table 2
24	A2	percent change	-0.27 percent	-1.91 to 1.37	not stated; full analysis; R0025222:Table 1
24	A2	percent change	-0.27 percent	-1.92 to 1.37	not stated; full analysis; R0025627:Table 2

Weight loss of 5 percent or more (6 lines; O11A)

Week	Arm	Statistic	Estimate	Events / N	Detail
24	A1	responders	39.1	9 / 23	not stated; full analysis; R0025222:Table 1
24	A1	responders	36.0	9 / 25	not stated; full analysis; R0025627:Table 2
24	A1	responders	40.9	9 / 22	not stated; per protocol; R0025627:Figure 2
24	A2	responders	0	0 / 20	not stated; full analysis; R0025222:Table 1
24	A2	responders	4.2	1 / 24	not stated; full analysis; R0025627:Table 2
24	A2	responders	5.0	1 / 20	not stated; per protocol; R0025627:Figure 2

Weight loss of 10 percent or more (4 lines; O11B)

Week	Arm	Statistic	Estimate	Events / N	Detail
24	A1	responders	13.0	3 / 23	not stated; full analysis; R0025222:Table 1
24	A1	responders	12.0	3 / 25	not stated; full analysis; R0025627:Table 2
24	A2	responders	0	0 / 20	not stated; full analysis; R0025222:Table 1
24	A2	responders	0.0	0 / 24	not stated; full analysis; R0025627:Table 2

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 25	not stated; safety; R0025627:Table 3
	A2	events				0 / 25	not stated; safety; R0025627:Table 3

Progression to type 2 diabetes (1 lines; O14)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 25	not stated; safety; R0025627:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 25	not stated; safety; R0025627:Table 3
	A2	events				0 / 25	not stated; safety; R0025627:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 25	not stated; safety; R0025627:Table 3
	A2	events				1 / 25	not stated; safety; R0025627:Table 3

Discontinuation due to adverse events (7 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	2 / 25	not stated; safety; R0025627:Table 3
A1	events	1 / 25	not stated; safety; abdominal pain; R0025627:Results
A1	events	1 / 25	not stated; safety; injection site pruritus and mass; R0025627:Results
A2	events	3 / 25	not stated; safety; R0025627:Table 3
A2	events	1 / 25	not stated; safety; dyspnea and fatigue; R0025627:Results
A2	events	1 / 25	not stated; safety; malaise; R0025627:Results
A2	events	1 / 25	not stated; safety; skin ulcer and vasculitis; R0025627:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 25	not stated; safety; R0025627:Table 3
	A2	events				3 / 25	not stated; safety; R0025627:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 25	not stated; safety; R0025627:Table 3
	A2	events				1 / 25	not stated; safety; R0025627:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 25	not stated; safety; R0025627:Table 3
	A2	events				3 / 25	not stated; safety; R0025627:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 25	not stated; safety; R0025627:Table 3
	A2	events				1 / 25	not stated; safety; R0025627:Table 3

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 25	not stated; safety; abdominal pain; R0025627:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 25	not stated; safety; R0025627:Table 3
	A2	events				0 / 25	not stated; safety; R0025627:Table 3