parallel randomized trial

NCT00700817

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension

Type 2 diabetes (adults)NCT00700817S002361

Design

Randomized: 665
Start year: 2008
Treatment: 26 weeks, follow-up 52 weeks
Countries: multinational
Sponsor: Novo Nordisk A/S (industry)
Eligibility: age 18 to 80; HbA1c 7.5 to 10%; BMI 45 or less; metformin 1500 mg/day or more for 3 months

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Liraglutide 1.2 mg subcutaneous once daily Liraglutide 1.2 mg	metformin 1500 mg/day or more; lifestyle: not reported	225	221
A2	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	metformin 1500 mg/day or more; lifestyle: not reported	221	218
A3	Sitagliptin Sitagliptin 100 mg	metformin 1500 mg/day or more; lifestyle: not reported	219	219

Baseline characteristics

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	Liraglutide 1.8 mg subcutaneous once daily A2	Sitagliptin A3
age	mean (years)	55.9	55.0	55.0
age	sd (years)	9.6	9.1	9.0
asian	n	6	4	1
black	n	22	16	10
bmi	mean (kg/m2)	32.6	33.1	32.6
bmi	sd (kg/m2)	5.2	5.1	5.4
diabetes duration	mean (years)	6.0	6.4	6.3
diabetes duration	sd (years)	4.5	5.4	5.4
female	n	109	105	99
hba1c	mean (percent)	8.4	8.4	8.5
hba1c	sd (percent)	0.8	0.7	0.7
hispanic	n	39	34	35
other race american indian alaska native	n	3	0	0
other race multiple	n	0	0	0
other race native hawaiian pacific islander	n	1	0	1
weight	mean (kg)	93.7	94.6
weight	sd (kg)	18.4	18.1
white	n	184	193	199

Analyses this trial contributes to

Results

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

HbA1c change (10 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1 vs A3	md	-0.34 percent		-0.51 to -0.16		not stated; full analysis; registry:outcomes
26	A1	change	-1.24 percent	0.07		211	not stated; full analysis; registry:outcomes
26	A2	change	-1.5 percent	0.06		214	not stated; full analysis; registry:outcomes
26	A2 vs A3	md	-0.6 percent		-0.77 to -0.43		not stated; full analysis; registry:outcomes
26	A3	change	-0.9 percent	0.07		210	not stated; full analysis; registry:outcomes
52	A1 vs A3	md	-0.40 percent		-0.59 to -0.22		not stated; other; R0024199:Results
52	A1	change	-1.29 percent		-1.43 to -1.15	211	not stated; other; R0024199:Results
52	A2	change	-1.51 percent		-1.65 to -1.37	214	not stated; other; R0024199:Results
52	A2 vs A3	md	-0.63 percent		-0.81 to -0.44		not stated; other; R0024199:Results
52	A3	change	-0.88 percent		-1.02 to -0.74	210	not stated; other; R0024199:Results

Body weight change in kilograms (diabetes) (8 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-2.86 kg	0.27		215	not stated; full analysis; registry:outcomes
26	A2	change	-3.38 kg	0.27		214	not stated; full analysis; registry:outcomes
26	A3	change	-0.96 kg	0.27		215	not stated; full analysis; registry:outcomes
52	A1	change	-2.78 kg		-3.39 to -2.17	215	not stated; other; R0024199:Results
52	A1 vs A3	md	-1.62 kg		-2.43 to -0.82		not stated; other; R0024199:Results
52	A2	change	-3.68 kg		-4.29 to -3.07	214	not stated; other; R0024199:Results
52	A2 vs A3	md	-2.53 kg		-3.33 to -1.72		not stated; other; R0024199:Results
52	A3	change	-1.16 kg		-1.77 to -0.55	215	not stated; other; R0024199:Results

HbA1c below 7 percent (6 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
26	A1	responders	43	221	not stated; full analysis; registry:outcomes
26	A2	responders	55	218	not stated; full analysis; registry:outcomes
26	A3	responders	22	219	not stated; full analysis; registry:outcomes
52	A1	responders	50	211	not stated; other; registry:outcomes
52	A2	responders	63	214	not stated; other; registry:outcomes
52	A3	responders	27	210	not stated; other; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (9 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	8.1	221	not stated; other; R0024199:Abstract
A1	events		1 / 221	not stated; safety; R0024199:Results
A1	events		1 / 221	not stated; other; R0024199:Results
A2	events		0 / 218	not stated; other; R0024199:Results
A2	events	8.3	218	not stated; other; R0024199:Abstract
A2	events		0 / 218	not stated; safety; R0024199:Results
A3	events	6.4	219	not stated; other; R0024199:Abstract
A3	events		0 / 219	not stated; other; R0024199:Results
A3	events		0 / 219	not stated; safety; R0024199:Results

Level 2 or 3 hypoglycemia (episode rate) (15 lines; O04B)

Arm	Statistic	Estimate	Events / N	Detail
A1	rate		221	not stated; other; registry:outcomes
A1	rate	0.143		not stated; other; R0024199:Results
A1	rate		221	not stated; safety; registry:outcomes
A1	rate		221	not stated; safety; registry:outcomes
A1	rate		221	not stated; other; registry:outcomes
A2	rate		218	not stated; other; registry:outcomes
A2	rate	0.154		not stated; other; R0024199:Results
A2	rate		218	not stated; safety; registry:outcomes
A2	rate		218	not stated; other; registry:outcomes
A2	rate		218	not stated; safety; registry:outcomes
A3	rate		219	not stated; other; registry:outcomes
A3	rate		219	not stated; safety; registry:outcomes
A3	rate	0.137		not stated; other; R0024199:Results
A3	rate		219	not stated; safety; registry:outcomes
A3	rate		219	not stated; other; registry:outcomes

Systolic blood pressure change (8 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-0.55 mmHg	0.89		213	not stated; full analysis; registry:outcomes
26	A2	change	-0.72 mmHg	0.89		214	not stated; full analysis; registry:outcomes
26	A3	change	-0.94 mmHg	0.89		213	not stated; full analysis; registry:outcomes
52	A1	change	-0.37 mmHg		-2.19 to 1.45	213	not stated; other; R0024199:Table 1
52	A1 vs A3	md	0.66 mmHg		-1.79 to 3.10		not stated; other; R0024199:Table 1
52	A2	change	-2.55 mmHg		-4.37 to -0.72	214	not stated; other; R0024199:Table 1
52	A2 vs A3	md	-1.53 mmHg		-3.97 to 0.92		not stated; other; R0024199:Table 1
52	A3	change	-1.03 mmHg		-2.85 to 0.79	213	not stated; other; R0024199:Table 1

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 221	not stated; other; R0024199:Table 2
A2	events	1 / 218	not stated; other; R0024199:Table 2
A3	events	2 / 219	not stated; other; R0024199:Table 2

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 218	not stated; other; heart failure; R0024199:Table 2

Health related quality of life total score (any instrument) (6 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	3.51 points	0.49		164	not stated; other; registry:outcomes
26	A2	change	4.35 points	0.48		171	not stated; other; registry:outcomes
26	A3	change	2.96 points	0.48		170	not stated; other; registry:outcomes
52	A1	change	3.3 points		2.3 to 4.3	163	not stated; other; R0024199:Results
52	A2	change	4.3 points		3.3 to 5.3	165	not stated; other; R0024199:Results
52	A3	change	3.0 points		2.0 to 4.0	169	not stated; other; R0024199:Results

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	10 / 221	not stated; other; R0024199:Table 2
A2	events	13 / 218	not stated; other; R0024199:Table 2
A3	events	12 / 219	not stated; other; R0024199:Table 2

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	14 / 225	not stated; randomized; registry:flow
A1	events	5 / 155	not stated; other; registry:flow
A2	events	10 / 176	not stated; other; registry:flow
A2	events	15 / 221	not stated; randomized; registry:flow
A3	events	4 / 219	not stated; randomized; registry:flow
A3	events	3 / 166	not stated; other; registry:flow

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	48 / 221	not stated; other; R0024199:Table 2
A2	events	60 / 218	not stated; other; R0024199:Table 2
A3	events	12 / 219	not stated; other; R0024199:Table 2

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	18 / 221	not stated; other; R0024199:Table 2
A2	events	23 / 218	not stated; other; R0024199:Table 2
A3	events	11 / 219	not stated; other; R0024199:Table 2

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	20 / 221	not stated; other; R0024199:Table 2
A2	events	27 / 218	not stated; other; R0024199:Table 2
A3	events	14 / 219	not stated; other; R0024199:Table 2

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	10 / 221	not stated; other; R0024199:Table 2
A2	events	13 / 218	not stated; other; R0024199:Table 2
A3	events	8 / 219	not stated; other; R0024199:Table 2

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 218	not stated; other; cholecystitis; R0024199:Table 2
	A3	events				1 / 219	not stated; other; acute cholecystitis; R0024199:Table 2

Acute pancreatitis (1 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 218	not stated; other; non-acute pancreatitis; R0024199:Results

Medullary thyroid carcinoma (3 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 221	not stated; other; R0024199:Results
A2	events	0 / 218	not stated; other; R0024199:Results
A3	events	0 / 219	not stated; other; R0024199:Results

Thyroid cancer (any) (3 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 221	not stated; other; R0024199:Results
A2	events	0 / 218	not stated; other; R0024199:Results
A3	events	0 / 219	not stated; other; R0024199:Results

Diabetic retinopathy complications (1 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 218	not stated; other; diabetic retinopathy; R0024199:Table 2

Death by suicide (3 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 221	not stated; other; R0024199:Table 2
A2	events	0 / 218	not stated; other; R0024199:Table 2
A3	events	0 / 219	not stated; other; R0024199:Table 2

Intestinal obstruction or ileus (1 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 218	not stated; other; subileus; R0024199:Table 2

Pancreatic cancer (1 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 218	not stated; other; R0024199:Results