parallel randomized trial

LEAD-6

Effect of Liraglutide or Exenatide Added to a Background Treatment of Metformin, Sulphonylurea or a Combination of Both on Glycaemic Control in Subjects With Type 2 Diabetes

Type 2 diabetes (adults)NCT00518882S002230

Design

Randomized: 464
Start year: 2007
Treatment: 26 weeks, follow-up 26 weeks
Countries: multinational (132 sites)
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 to 80; HbA1c 7.0 to 11.0 percent; BMI 45 or less; stable metformin, sulfonylurea or both

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: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg once daily	metformin and/or sulfonylurea; lifestyle: not reported	233	227	202
A2	Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug twice daily	metformin and/or sulfonylurea; lifestyle: not reported	231	226	187

Baseline characteristics

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

Characteristic	Statistic	Liraglutide 1.8 mg subcutaneous once daily A1	Exenatide 10 ug subcutaneous twice daily A2
age	mean (years)	56.3	57.1
age	sd (years)	9.8	10.8
asian	n	0	4
black	n	13	12
bmi	mean (kg/m2)	32.9	32.9
bmi	sd (kg/m2)	5.5	5.7
diabetes duration	mean (years)	8.5	7.9
diabetes duration	sd (years)	6.2	5.9
female	n	119	104
hba1c	mean (percent)	8.2	8.1
hba1c	sd (percent)	1.0	1.0
hispanic	n	32	25
other background: metformin and sulfonylurea	n	145	147
other background: metformin only	n	64	63
other background: sulfonylurea only	n	24	21
other race american indian alaska native	n	0	1
other race multiple	n	0	0
other race native hawaiian pacific islander	n	1	1
weight	mean (kg)	93.1	93.0
weight	sd (kg)	20.1	19.5
white	n	216	210

Analyses this trial contributes to

Results

20 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	Events / N	Detail
26	A1	change	-1.12 percent	0.08		227	not stated; modified itt; registry:outcomes
26	A1 vs A2	md	-0.33 percent		-0.47 to -0.18		not stated; modified itt; registry:outcomes
26	A2	change	-0.79 percent	0.08		226	not stated; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-3.24 kg	0.33		231	not stated; modified itt; registry:outcomes
26	A1 vs A2	md	-0.38 kg		-0.99 to 0.23		not stated; modified itt; registry:outcomes
26	A2	change	-2.87 kg	0.33		229	not stated; modified itt; registry:outcomes

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders	53			233	not stated; modified itt; registry:outcomes
26	A2	responders	42			231	not stated; modified itt; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (1 lines; O04)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 235	not stated; safety; registry:outcomes

Level 2 or 3 hypoglycemia (episode rate) (4 lines; O04B)

Arm	Statistic	Detail
A1	rate	not stated; safety; registry:outcomes
A1	rate	not stated; safety; registry:outcomes
A2	rate	not stated; safety; registry:outcomes
A2	rate	not stated; safety; registry:outcomes

Health related quality of life total score (any instrument) (5 lines; O24C)

Week	Arm	Statistic	Estimate	95% CI	Detail
26	A1	change	4.71 points		not stated; modified itt; R0023843:Results
26	A1	final	15.18 points		not stated; per protocol; R0023843:Results
26	A1 vs A2	md	3.04 points	1.73 to 4.35	not stated; modified itt; R0023843:Results
26	A2	change	1.66 points		not stated; modified itt; R0023843:Results
26	A2	final	13.30 points		not stated; per protocol; R0023843:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				23 / 235	not stated; randomized; registry:flow
	A2	events				31 / 232	not stated; randomized; registry:flow