parallel randomized trial

TODINELI

A Randomized, Double-blinded, Single-centre, Parallel-group, Placebo-controlled, Prospective Trial of Neuroprotective Effect of Liraglutide for Treatment of Diabetic Neuropathy.

Type 1 diabetes Other conditions NCT02138045S001560

Design

Randomized: 48
Start year: 2014
Treatment: 26 weeks, follow-up 26 weeks
Countries: Denmark (1 sites)
Sponsor: Aalborg University Hospital (mixed)
Eligibility: age over 18; type 1 diabetes 2 years or more; HbA1c 6.5 percent or more; BMI over 22; confirmed polyneuropathy; eGFR 60 or more

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: completers only

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide subcutaneous once daily, flexible dose: 1.2 or 1.8 mg by tolerability Liraglutide 1.2 to 1.8 mg	basal and bolus insulin or insulin pump; lifestyle: not reported		19
A2	Placebo Placebo	basal and bolus insulin or insulin pump; lifestyle: not reported		20

Baseline characteristics

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

Characteristic	Statistic	Liraglutide subcutaneous once daily, flexible dose: 1.2 or 1.8 mg by tolerability A1	Placebo A2
age	mean (years)	51	50
age	sd (years)	10	8
bmi	mean (kg/m2)	29	29
bmi	sd (kg/m2)	4	5
diabetes duration	mean (years)	32	32
diabetes duration	median (years)	31	32
diabetes duration	sd (years)	11	7
egfr	median (mL/min/1.73 m2)	85	85
egfr	q1 (mL/min/1.73 m2)	65	72
egfr	q3 (mL/min/1.73 m2)	90	90
hba1c	mean (mmol/mol)	69	64
hba1c	median (percent)	8.5	7.9
hba1c	q1 (percent)	7.5	7.3
hba1c	q3 (percent)	9.5	8.6
hba1c	sd (mmol/mol)	12	10
insulin dose	median (U/day)	55.0	44.0
insulin dose	q1 (U/day)	44.0
insulin dose	q3 (U/day)	82.0	68.0
other male	n	17	14
other male	percent	90	70
sbp	mean (mmHg)	153	150
sbp	sd (mmHg)	16	16
weight	mean (kg)	93	92
weight	sd (kg)	17	17

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	final	mmol/mol		19	not stated; completers; R0012788:Table 3
26	A1 vs A2	md	1.18 percent	-4.31 to 6.98		not stated; completers; R0012788:Table 3
26	A2	final	mmol/mol		20	not stated; completers; R0012788:Table 3

Total daily insulin dose change (3 lines; O06)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	final	U/day		19	not stated; completers; R0012788:Table 3
26	A1 vs A2	md	-1.57 percent	-18.14 to 18.34		not stated; completers; R0012788:Table 3
26	A2	final	U/day		20	not stated; completers; R0012788:Table 3