parallel randomized trial

NCT02617654

A Randomized, Double-blinded Placebo-controlled, Paralleled Designed, Investigator Sponsored Study of the Effect of the GLP-1 Receptor Agonist Liraglutide on Beta-cell Function in C-peptide Positive Type 1 Diabetic Patients

Type 1 diabetes NCT02617654S002261

Design

Randomized: 18
Start year: 2015
Treatment: 52 weeks, follow-up 65 weeks
Countries: Sweden (1 sites)
Sponsor: Per-Ola Carlsson (mixed)
Eligibility: age 18 or older; T1D 5 years or longer; HbA1c 45 to 75 mmol/mol; fasting C-peptide above 1.5 pmol/L

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	basal bolus insulin; lifestyle: not reported	8
A2	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg daily	basal bolus insulin; lifestyle: not reported	10

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Liraglutide 1.8 mg subcutaneous once daily A2
age	mean (years)	24.6	24.0
age	sd (years)	3.4	3.5
bmi	mean (kg/m2)	25.7	24.1
bmi	sd (kg/m2)	3.7	2.6
diabetes duration	mean (years)	9.0	10.0
diabetes duration	sd (years)	3.5	4.8
hba1c	mean (mmol/mol)	59.9	54.3
hba1c	sd (mmol/mol)	8.1	7.4
other male	percent	62	80
weight	mean (kg)	76.7	75.9
weight	sd (kg)	15.3	7.5

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Detail
52	A1	final	60.4 mmol/mol	6.1		not stated; other; R0012710:Supplement Table S2
52	A2	final	53.3 mmol/mol	8.1		not stated; other; R0012710:Supplement Table S2
52	A2 vs A1	md	-7.5 mmol/mol		-14.5 to 0.5	not stated; modified itt; R0012710:Table 2

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 8	not stated; randomized; R0012710:Results
A1	events	5 / 8	not stated; randomized; R0012710:Supplement Table S3
A2	events	5 / 10	not stated; randomized; R0012710:Supplement Table S3
A2	events	0 / 10	not stated; randomized; R0012710:Results

Total daily insulin dose change (2 lines; O06)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	final	0.60 U/kg/day	0.16			not stated; other; R0012710:Supplement Table S2
52	A2	final	0.56 U/kg/day	0.15			not stated; other; R0012710:Supplement Table S2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 8	not stated; randomized; R0012710:Results
	A2	events				2 / 10	not stated; randomized; R0012710: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 / 8	not stated; randomized; R0012710:Results
	A2	events				2 / 10	not stated; randomized; R0012710:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 8	not stated; randomized; R0012710:Results
	A2	events				0 / 10	not stated; randomized; R0012710:Results

Diabetic ketoacidosis (2 lines; O30)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 8	not stated; randomized; R0012710:Results
	A2	events				0 / 10	not stated; randomized; R0012710:Results

Severe hypoglycemia (type 1 diabetes) (2 lines; O31)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 8	not stated; randomized; R0012710:Results
	A2	events				0 / 10	not stated; randomized; R0012710:Results