crossover randomized trial

GOLD

Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia: "The GOLD-Study"

Design

Randomized: 35
Start year: 2016
Treatment: 3 weeks
Countries: Switzerland (1 sites)
Sponsor: University Hospital, Basel, Switzerland (non industry)
Eligibility: age 18 to 65; primary polydipsia, intake over 3000 mL/day and urine over 50 mL/kg/day

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Dulaglutide 1.5 mg subcutaneous once weekly Dulaglutide 1.5 mg	lifestyle: not reported	35	34
A2	Placebo Placebo	lifestyle: not reported	35	34

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

Characteristic	Statistic	Whole trial ALL
age	median (years)	29.5
age	q1 (years)	26.0
age	q3 (years)	38.8
bmi	median (kg/m2)	23.1
bmi	q1 (kg/m2)	20.7
bmi	q3 (kg/m2)	25.5
female	n	23
female	percent	67.6
white	n	34
white	percent	100

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

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 35	not stated; randomized; R0013314:Results
	A2	events				0 / 35	not stated; randomized; R0013314:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 35	not stated; randomized; recurrent vomiting; R0013314:Results
	A2	events				0 / 35	not stated; randomized; recurrent vomiting; R0013314:Results