parallel randomized trial

NCT00993720

Effect of GLP-1 on Insulin-dose, Risk of Hypoglycemia and Gastric Emptying Rate in Patients With Type 1 Diabetes

Design

Randomized: 20
Start year: 2009
Treatment: 4 weeks, follow-up 4 weeks
Countries: Denmark
Sponsor: Hvidovre University Hospital (non industry)
Eligibility: age 18 to 50; BMI 18 to 27; HbA1c up to 8.5; randomized part C-peptide negative

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.2 mg subcutaneous once daily Liraglutide plus insulin (C-peptide negative)	basal bolus insulin reduced at start then titrated to glucose target; lifestyle: none		9
A2	Standard care or no added treatment Insulin alone (C-peptide negative)	basal bolus insulin titrated to glucose 5 to 7 mmol/L; lifestyle: none		10

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

Characteristic	Statistic	Liraglutide 1.2 mg subcutaneous once daily A1	Standard care or no added treatment A2
age	mean (years)	35.7	32.9
age	se (years)	2.2	1.7
bmi	mean (kg/m2)	24.6	23.1
bmi	se (kg/m2)	0.7	0.6
diabetes duration	mean (years)	17.3	23.1
diabetes duration	se (years)	2.5	1.6
female	n	0	1
hba1c	mean (percent)	7.5	7.1
hba1c	se (percent)	0.2	0.3
insulin dose	mean (U/kg/day)	0.72	0.62
insulin dose	se (U/kg/day)	0.08	0.04

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
4	A1	change	-0.47 percent	0.15	9	not stated; modified itt; R0027162:Results
4	A1	final	7.0 percent	0.1	9	not stated; modified itt; R0027162:Table 1
4	A2	change	-0.18 percent	0.1	10	not stated; modified itt; R0027162:Results
4	A2	final	6.9 percent	0.2	10	not stated; modified itt; R0027162:Table 1

Total daily insulin dose change (5 lines; O06)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
4	A1	change	-0.13 U/kg/day	0.04	9	not stated; modified itt; R0027162:Results
4	A1	final	0.59 U/kg/day	0.06	9	not stated; modified itt; R0027162:Table 1
4	A1	percent change	-15.8 percent	5.5	9	not stated; modified itt; R0027162:Results
4	A2	change	0.017 U/kg/day	0.02	10	not stated; modified itt; R0027162:Results
4	A2	final	0.64 U/kg/day	0.05	10	not stated; modified itt; R0027162:Table 1

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 10	not stated; modified itt; R0027162:Results

Vomiting (1 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 10	not stated; modified itt; R0027162:Results

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 10	not stated; modified itt; R0027162:Results