parallel randomized trial

NCT01296412

A Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing the Efficacy and Safety of a Sitagliptin-Based Treatment Paradigm to a Liraglutide-Based Treatment Paradigm in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy

Type 2 diabetes (adults)NCT01296412S000080

Design

Randomized: 653
Start year: 2011
Treatment: 26 weeks, follow-up 26 weeks
Countries: multinational (111 sites)
Sponsor: Merck Sharp & Dohme (industry)
Eligibility: age 18 to 79; HbA1c 7.0 to 11.0 percent on metformin 1500 mg or more; eGFR 60 or more

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: per protocol
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Sitagliptin Oral strategy: sitagliptin 100 mg with glimepiride if needed	metformin; lifestyle: standard	326	269
A2	Liraglutide flexible dose injection once daily Injectable strategy: liraglutide 1.2 mg uptitrated to 1.8 mg if needed	metformin; lifestyle: standard	327	253

Baseline characteristics

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

Characteristic	Statistic	Sitagliptin A1	Liraglutide flexible dose injection once daily A2
age	mean (years)	56.9	57.6
age	sd (years)	10.0	10.8
black	n	9	20
black	percent	3	6
bmi	mean (kg/m2)	32.6	32.7
bmi	sd (kg/m2)	5.9	6.1
diabetes duration	mean (years)	7.6	8.2
diabetes duration	median (years)	6.0	6.0
diabetes duration	sd (years)	4.8	6.2
hba1c	mean (percent)	8.2	8.1
hba1c	sd (percent)	1.1	0.9
other male	n	178	180
other male	percent	55	55
other multiracial	n	21	20
other multiracial	percent	6	6
other race other	n	15	14
other race other	percent	5	4
weight	mean (kg)	91.0	92.1
weight	sd (kg)	20.5	20.4
white	n	281	273
white	percent	86	84

Analyses this trial contributes to

Results

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	change	-1.32 percent	-1.42 to -1.23	269	not stated; per protocol; registry:outcomes
26	A1	change	-1.3 percent	-1.4 to -1.2	269	not stated; per protocol; R0026295:Table 2
26	A1 vs A2	md	0.1 percent	-0.1 to 0.2		not stated; per protocol; R0026295:Table 2
26	A1 vs A2	md	0.09 percent	-0.05 to 0.23		not stated; per protocol; registry:outcomes
26	A2	change	-1.4 percent	-1.5 to -1.3	253	not stated; per protocol; R0026295:Table 2
26	A2	change	-1.42 percent	-1.51 to -1.32	253	not stated; per protocol; registry:outcomes

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	change	-0.4 kg	-0.8 to -0.0	285	not stated; completers; R0026295:Table 4
26	A1 vs A2	md	2.3 kg	1.8 to 2.9		not stated; completers; R0026295:Table 4
26	A2	change	-2.8 kg	-3.2 to -2.3	262	not stated; completers; R0026295:Table 4

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1 vs A2	rd	-9.5	-17.4 to -1.5		not stated; per protocol; R0026295:Results
26	A1	responders	62.8		269	not stated; per protocol; R0026295:Results
26	A2	responders	72.3		253	not stated; per protocol; R0026295:Results

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

Arm	Statistic	Events / N	Detail
A1	events	39 / 326	not stated; safety; R0026295:Table 3
A1	events	1 / 326	not stated; safety; R0026295:Results
A2	events	13 / 324	not stated; safety; R0026295:Table 3
A2	events	1 / 324	not stated; safety; R0026295:Results

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	change	0.9 mmHg	-0.5 to 2.2	285	not stated; completers; R0026295:Table 4
26	A1 vs A2	md	2.8 mmHg	0.8 to 4.8		not stated; completers; R0026295:Table 4
26	A2	change	-1.9 mmHg	-3.3 to -0.5	262	not stated; completers; R0026295:Table 4

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 326	not stated; safety; R0026295:Table 3
	A2	events				0 / 324	not stated; safety; R0026295:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				17 / 326	not stated; safety; R0026295:Table 3
	A2	events				12 / 324	not stated; safety; R0026295:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 326	not stated; safety; R0026295:Table 3
	A2	events				29 / 324	not stated; safety; R0026295:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				10 / 326	not stated; safety; R0026295:Table 3
	A2	events				63 / 324	not stated; safety; R0026295:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 326	not stated; safety; R0026295:Table 3
	A2	events				21 / 324	not stated; safety; R0026295:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 326	not stated; safety; R0026295:Table 3
	A2	events				35 / 324	not stated; safety; R0026295:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 326	not stated; safety; R0026295:Table 3
	A2	events				6 / 324	not stated; safety; R0026295:Table 3

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 326	not stated; safety; cholecystitis infective; registry:adverse_events
	A2	events				0 / 324	not stated; safety; cholecystitis infective; registry:adverse_events

Any cancer (6 lines; O39)

Arm	Statistic	Events / N	Detail
A1	events	0 / 326	not stated; safety; breast cancer; registry:adverse_events
A1	events	0 / 326	not stated; safety; prostate cancer; registry:adverse_events
A1	events	1 / 326	not stated; safety; squamous cell carcinoma; registry:adverse_events
A2	events	1 / 324	not stated; safety; breast cancer; registry:adverse_events
A2	events	1 / 324	not stated; safety; prostate cancer; registry:adverse_events
A2	events	0 / 324	not stated; safety; squamous cell carcinoma; registry:adverse_events