parallel randomized trial

NCT01617434

The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

Type 2 diabetes (adults)NCT01617434S000926

Design

Randomized: 451
Start year: 2012
Treatment: 26 weeks, follow-up 27 weeks
Countries: Argentina, Canada, Finland, Germany, India, Mexico, Netherlands, Serbia, United States (76 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: age 18 to 80; HbA1c 7.0 to 10.0 percent; BMI 20 to 45; basal insulin analogue 20 U or more with or without metformin

Conduct and analysis

Blinding: double blind
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: not stated
Analysis population: full analysis
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg/day	basal insulin analogue (glargine or detemir) with or without metformin; lifestyle: not reported	226	215
A2	Placebo Placebo	basal insulin analogue (glargine or detemir) with or without metformin; insulin not above prestudy dose, reduced 20 percent if HbA1c 8.0 or less; lifestyle: not reported	225	217

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	Placebo A2
age	mean (years)	59.3	57.5
age	sd (years)	9.2	11.1
bmi	mean (kg/m2)	32.3	32.2
bmi	sd (kg/m2)	5.6	5.7
diabetes duration	mean (years)	12.1	12.1
diabetes duration	sd (years)	7.1	6.8
female	n	105	89
female	percent	46.7	39.6
hba1c	mean (percent)	8.2	8.3
hba1c	sd (percent)	0.8	0.9
insulin dose	mean (U/kg/day)	0.46	0.45
metformin use	percent	92.0	93.3
weight	mean (kg)	90.2	91.9
weight	sd (kg)	20.0	19.3

Analyses this trial contributes to

Results

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.3 percent				not stated; full analysis; R0026247:Results
26	A1	change	-1.30 percent	1.015		215	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-1.2 percent		-1.4 to -1.0		not stated; full analysis; R0026247:Results
26	A1 vs A2	md	-1.1 percent		-1.3 to -1.0		not stated; full analysis; R0026247:Results
26	A2	change	-0.11 percent	1.088		217	not stated; full analysis; registry:outcomes
26	A2	change	-0.1 percent				not stated; full analysis; R0026247:Results

Body weight change in kilograms (diabetes) (5 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-3.54 kg	3.669		215	not stated; full analysis; registry:outcomes
26	A1	change	-3.5 kg				not stated; full analysis; R0026247:Results
26	A1 vs A2	md	-3.1 kg		-3.9 to -2.4		not stated; full analysis; R0026247:Results
26	A2	change	-0.4 kg				not stated; full analysis; R0026247:Results
26	A2	change	-0.42 kg	3.909		216	not stated; full analysis; registry:outcomes

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1 vs A2	or	8.91	5.45 to 14.59		not stated; full analysis; R0026247:Table 2
26	A1	responders	59.2		225	not stated; full analysis; R0026247:Table 2
26	A2	responders	14.0		225	not stated; full analysis; R0026247:Table 2

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 225	not stated; safety; R0026247:Results
A1	events	41 / 225	not stated; safety; R0026247:Table 4
A2	events	28 / 225	not stated; safety; R0026247:Table 4
A2	events	0 / 225	not stated; safety; R0026247:Results

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

Arm	Statistic	Estimate	95% CI	Detail
A1 vs A2	rate ratio	2.00	1.03 to 3.89	not stated; safety; R0026247:Table 4
A1	rate	126		not stated; safety; R0026247:Table 4
A2	rate	83		not stated; safety; R0026247:Table 4

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Detail
26	A1 vs A2	md	-5.02 mmHg	-7.45 to -2.59	not stated; full analysis; R0026247:Table 2
26	A1	change	-5.78 mmHg		not stated; full analysis; R0026247:Table 2
26	A2	change	-0.76 mmHg		not stated; full analysis; R0026247:Table 2

Health related quality of life total score (any instrument) (3 lines; O24C)

Week	Arm	Statistic	Estimate	95% CI	Detail
26	A1	change	0.49 points		not stated; full analysis; R0026247:Table 2
26	A1 vs A2	md	0.37 points	0.20 to 0.55	not stated; full analysis; R0026247:Table 2
26	A2	change	0.11 points		not stated; full analysis; R0026247:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				11 / 225	not stated; safety; R0026247:Table 3
	A2	events				7 / 225	not stated; safety; R0026247:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				12 / 225	not stated; safety; R0026247:Results
	A2	events				3 / 225	not stated; safety; R0026247:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				50 / 225	not stated; safety; R0026247:Table 3
	A2	events				7 / 225	not stated; safety; R0026247:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				20 / 225	not stated; safety; R0026247:Table 3
	A2	events				2 / 225	not stated; safety; R0026247:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				24 / 225	not stated; safety; R0026247:Table 3
	A2	events				11 / 225	not stated; safety; R0026247:Table 3

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 225	not stated; safety; R0026247:Results
	A2	events				0 / 225	not stated; safety; R0026247:Results

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 225	not stated; safety; R0026247:Results
	A2	events				0 / 225	not stated; safety; R0026247:Results

Intestinal obstruction or ileus (2 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 225	while on treatment; safety; ileus; registry:adverse_events
	A2	events				0 / 225	while on treatment; safety; ileus; registry:adverse_events

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 225	not stated; safety; R0026247:Results
	A2	events				0 / 225	not stated; safety; R0026247:Results

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 225	not stated; safety; R0026247:Table 3
	A2	events				2 / 225	not stated; safety; R0026247:Table 3