parallel randomized trial

NCT00976937

A Randomized, Double-blind, Double-dummy, 2-arm Parallel-group, Multicenter 24-week Study Comparing the Efficacy and Safety of AVE0010 to Sitagliptin as add-on to Metformin in Obese Type 2 Diabetic Patients Younger Than 50 and Not Adequately Controlled With Metformin

Type 2 diabetes (adults)NCT00976937S000415

Design

Randomized: 319
Start year: 2009
Treatment: 24 weeks, follow-up 24 weeks
Countries
Sponsor: Sanofi (industry)
Eligibility: age 18 to under 50; BMI 30 or more; HbA1c 7.0 to 10 percent; metformin at least 1.5 g/day

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Lixisenatide 20 ug subcutaneous once daily Lixisenatide 20 ug	metformin; lifestyle: not reported	158	158
A2	Sitagliptin Sitagliptin 100 mg	metformin; lifestyle: not reported	161	161

Baseline characteristics

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

Characteristic	Statistic	Lixisenatide 20 ug subcutaneous once daily A1	Sitagliptin A2
age	mean (years)	42.7	43.4
age	sd (years)	5.2	4.7
asian	percent	0.6	0.6
black	percent	5.1	6.8
bmi	mean (kg/m2)	36.8	36.8
bmi	sd (kg/m2)	7.3	6.3
diabetes duration	max (years)	29.6	19.6
diabetes duration	mean (years)	4.4	4.4
diabetes duration	median (years)	3.2	3.4
diabetes duration	min (years)	1.0	1.0
diabetes duration	sd (years)	3.9	3.6
hba1c	mean (percent)	8.16	8.1
hba1c	sd (percent)	0.89	1.0
other male	percent	34.8	45.3
other race other	percent	10.8	13.7
weight	mean (kg)	98.5	100.6
weight	sd (kg)	23.5	23.8
white	percent	83.5	78.9

Analyses this trial contributes to

Results

31 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	-0.7 percent	0.1		150	hypothetical; modified itt; R0012687:Results
24	A1 vs A2	md	0.1 percent		-0.2 to 0.3		hypothetical; modified itt; R0012687:Results
24	A2	change	-0.7 percent	0.1		160	hypothetical; modified itt; R0012687:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-2.51 kg	0.294		152	hypothetical; modified itt; registry:outcomes
24	A1 vs A2	md	-1.3 kg		-2.1 to -0.6		hypothetical; modified itt; R0012687:Results
24	A2	change	-1.17 kg	0.304		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	40.7		150	hypothetical; modified itt; R0012687:Results
24	A1 vs A2	rd	0.8	-9.7 to 11.3		hypothetical; modified itt; R0012687:Results
24	A2	responders	40.0		160	hypothetical; modified itt; R0012687:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 158	not stated; safety; R0012687:Table 2
	A2	events				0 / 161	not stated; safety; R0012687:Table 2

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	18.4			152	hypothetical; modified itt; registry:outcomes
24	A2	responders	11.9			160	hypothetical; modified itt; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 158	not stated; safety; R0012687:Table 2
	A2	events				0 / 161	not stated; safety; R0012687:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 158	not stated; safety; R0012687:Table 2
	A2	events				3 / 161	not stated; safety; R0012687:Table 2

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	4 / 158	not stated; safety; R0012687:Table 2
A1	events	4 / 158	not stated; randomized; registry:flow
A2	events	5 / 161	not stated; safety; R0012687:Table 2
A2	events	5 / 161	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				28 / 158	not stated; safety; R0012687:Table 2
	A2	events				11 / 161	not stated; safety; R0012687:Table 2

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 158	not stated; safety; R0012687:Table 2
	A2	events				0 / 161	not stated; safety; R0012687:Table 2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 158	not stated; safety; R0012687:Table 2
	A2	events				12 / 161	not stated; safety; R0012687: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				1 / 158	not stated; safety; R0012687:Table 2
	A2	events				0 / 161	not stated; safety; R0012687:Table 2

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 158	not stated; safety; R0012687:Table 2
	A2	events				0 / 161	not stated; safety; R0012687:Table 2