parallel randomized trial

NCT01476475

A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients

Type 2 diabetes (adults)NCT01476475S000191

Design

Randomized: 323
Start year: 2011
Treatment: 24 weeks, follow-up 24 weeks
Countries: multinational (67 sites)
Sponsor: Sanofi (industry)
Eligibility: Adults with T2D; HbA1c 7 to 10 percent on metformin at least 1.5 g/day; insulin naive

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: modified itt
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	IGlarLixi 2:1 pen subcutaneous once daily titrated LixiLan (insulin glargine and lixisenatide 2 U per 1 ug)	metformin; lifestyle: not reported	161	160
A2	Insulin glargine Insulin glargine (Gla-100)	metformin; lifestyle: not reported	162	161

Baseline characteristics

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

Characteristic	Statistic	IGlarLixi 2:1 pen subcutaneous once daily titrated A1	Insulin glargine A2
age	mean (years)	56.9	56.6
age	sd (years)	9.5	9.4
asian	n	1	1
black	n	2	1
bmi	mean (kg/m2)	32.2	32.0
bmi	sd (kg/m2)	4.8	4.4
diabetes duration	mean (years)	6.3	7.1
diabetes duration	sd (years)	4.3	5.3
female	n	81	77
hba1c	mean (percent)	8.1	8.0
hba1c	sd (percent)	0.8	0.8
hispanic	n	35	30
other male	n	80	85
other male	percent	49.7	52.5
other metformin dose	mean (mg/day)	2076	2094
other metformin dose	sd (mg/day)	441	416
weight	mean (kg)	90.1	91.6
weight	sd (kg)	17.6	16.7
white	n	158	160
white	percent	98.1	98.8

Analyses this trial contributes to

Results

33 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
24	A1	change	-1.82 percent	0.058		160	hypothetical; modified itt; registry:outcomes
24	A1 vs A2	md	-0.17 percent		-0.31 to -0.04		hypothetical; modified itt; R0021236:p4
24	A2	change	-1.64 percent	0.057		161	hypothetical; 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
24	A1	change	-0.97 kg	0.289		159	hypothetical; modified itt; registry:outcomes
24	A1 vs A2	md	-1.44 kg		-2.1 to -0.8		hypothetical; modified itt; R0021236:p5
24	A2	change	0.48 kg	0.282		160	hypothetical; modified itt; registry:outcomes

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	responders	84.4		160	hypothetical; modified itt; registry:outcomes
24	A1 vs A2	rd	6.2	-2.2 to 14.5		hypothetical; modified itt; R0021236:p4
24	A2	responders	78.3		161	hypothetical; modified itt; registry:outcomes

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

Arm	Statistic	Events / N	Detail
A1	events	35 / 161	not stated; safety; R0021236:Table 2
A1	events	0 / 161	not stated; safety; R0021236:p5
A2	events	37 / 162	not stated; safety; R0021236:Table 2
A2	events	0 / 162	not stated; safety; R0021236:p5

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 161	not stated; safety; R0021236:Table 2
	A2	events				0 / 162	not stated; safety; R0021236:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 161	not stated; safety; R0021236:Table 2
	A2	events				6 / 162	not stated; safety; R0021236:Table 2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 161	not stated; safety; R0021236:Table 2
	A2	events				0 / 162	not stated; safety; R0021236:Table 2

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				12 / 161	not stated; safety; R0021236:Table 2
	A2	events				0 / 162	not stated; safety; R0021236:Table 2

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 161	not stated; safety; R0021236:Table 2
	A2	events				1 / 162	not stated; safety; R0021236:Table 2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 161	not stated; safety; R0021236:Table 2
	A2	events				6 / 162	not stated; safety; R0021236:Table 2

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 161	not stated; safety; R0021236:Table 2
	A2	events				0 / 162	not stated; safety; R0021236:Table 2

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 161	not stated; safety; R0021236:p5
	A2	events				0 / 162	not stated; safety; R0021236:p5

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 161	not stated; safety; R0021236:p5
	A2	events				0 / 162	not stated; safety; R0021236:p5

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 161	not stated; safety; ovarian cancer; registry:adverse_events
	A2	events				0 / 162	not stated; safety; ovarian cancer; registry:adverse_events