parallel randomized trial

S002879

Other conditionsS002879

Design

Randomized: 30
Start year
Treatment: 52.14 weeks, follow-up 52.14 weeks
Countries: Slovakia (1 sites)
Sponsor: (non industry)
Eligibility: age 18 to 65; relapsing remitting MS; EDSS below 5; stable natalizumab at least 3 months; no drug treated diabetes

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Dulaglutide 0.75 mg subcutaneous once weekly Adjunctive dulaglutide 0.75 mg weekly	natalizumab; lifestyle: not reported	15	15	15
A2	Standard care or no added treatment Control without adjunctive therapy	natalizumab; lifestyle: not reported	15	13

Baseline characteristics

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

Characteristic	Statistic	Dulaglutide 0.75 mg subcutaneous once weekly A1	Standard care or no added treatment A2
age	mean (years)	41.7	36.8
age	sd (years)	10.0	6.3
bmi	mean (kg/m2)	26.4	23.5
bmi	sd (kg/m2)	3.4	3.9
female	n	7	7
female	percent	46.7	53.8
sbp	mean (mmHg)	122.9	113.9
sbp	sd (mmHg)	14.8	10.9
waist	mean (cm)	92.4	83.2
waist	sd (cm)	11.9	10.6
weight	mean (kg)	80.3
weight	sd (kg)	11.4

Results

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

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 15	not stated; modified itt; R0001665:Results
A1	events	0 / 15	not stated; modified itt; R0001665:Results
A2	events	0 / 13	not stated; modified itt; R0001665:Results
A2	events	0 / 13	not stated; modified itt; R0001665:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Nonarteritic anterior ischemic optic neuropathy (2 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Gastroparesis (2 lines; O37A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Intestinal obstruction or ileus (2 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 15	not stated; modified itt; R0001665:Results
	A2	events				0 / 13	not stated; modified itt; R0001665:Results