parallel randomized trial

NCT02973321

A 26-Week Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study to Assess the Safety and Efficacy of SAR425899 in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT02973321S000763

Design

Randomized: 296
Start year: 2016
Treatment: 26 weeks, follow-up 26.4 weeks
Countries
Sponsor: Sanofi (industry)
Eligibility: adults with type 2 diabetes and overweight or obesity

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	lifestyle: not reported	33	33
A2	SAR425899 SAR425899 0.12 mg	lifestyle: not reported	66	66
A3	SAR425899 SAR425899 0.16 mg	lifestyle: not reported	66	66
A4	SAR425899 SAR425899 0.20 mg	lifestyle: not reported	64	64
A5	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	lifestyle: not reported	67	67

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	SAR425899 0.12 mg A2	SAR425899 0.16 mg A3	SAR425899 0.20 mg A4	Liraglutide 1.8 mg subcutaneous once daily A5
age	mean (years)	56.2	56.8	54.5	55.0	56.1
age	sd (years)	9.3	9.0	10.1	10.4	11.4
asian	n	0	1	1	2	1
black	n	2	6	6	2	4
bmi	mean (kg/m2)	32.07	33.67	34.23	33.63	34.23
bmi	sd (kg/m2)	4.41	5.37	4.68	4.35	5.51
female	n	15	29	35	28	36
hba1c	mean (percent)	8.04	7.97	7.99	8.14	8.11
hba1c	sd (percent)	0.86	0.88	0.85	0.94	0.86
hispanic	n	15	19	25	28	13
other race american indian alaska native	n	0	0	0	0	1
other race other	n	0	0	0	1	0
white	n	31	59	59	59	61

Analyses this trial contributes to

Results

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

HbA1c change (7 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-0.663 percent	0.169		33	not stated; randomized; registry:outcomes
26	A2	change	-1.517 percent	0.137		66	not stated; randomized; registry:outcomes
26	A2 vs A1	md	-0.854 percent		-1.264 to -0.444		not stated; randomized; registry:outcomes
26	A3	change	-1.618 percent	0.133		66	not stated; randomized; registry:outcomes
26	A3 vs A1	md	-0.956 percent		-1.359 to -0.552		not stated; randomized; registry:outcomes
26	A4	change	-1.562 percent	0.131		64	not stated; randomized; registry:outcomes
26	A5	change	-1.312 percent	0.118		67	not stated; randomized; registry:outcomes

Body weight change in kilograms (diabetes) (7 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.759 kg	0.734		33	not stated; randomized; registry:outcomes
26	A2	change	-4.276 kg	0.564		66	not stated; randomized; registry:outcomes
26	A2 vs A1	md	-2.517 kg		-4.264 to -0.77		not stated; randomized; registry:outcomes
26	A3	change	-5.330 kg	0.549		66	not stated; randomized; registry:outcomes
26	A3 vs A1	md	-3.57 kg		-5.309 to -1.832		not stated; randomized; registry:outcomes
26	A4	change	-4.407 kg	0.559		64	not stated; randomized; registry:outcomes
26	A5	change	-4.590 kg	0.521		67	not stated; randomized; registry:outcomes

HbA1c below 7 percent (5 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
26	A1	responders	36.4	33	not stated; randomized; registry:outcomes
26	A2	responders	66.7	66	not stated; randomized; registry:outcomes
26	A3	responders	68.2	66	not stated; randomized; registry:outcomes
26	A4	responders	65.6	64	not stated; randomized; registry:outcomes
26	A5	responders	67.2	67	not stated; randomized; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 33	not stated; safety; hypoglycaemic unconsciousness; registry:adverse_events
	A5	events				0 / 67	not stated; safety; hypoglycaemic unconsciousness; registry:adverse_events

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

Week	Arm	Statistic	Estimate	Events / N	Detail
26	A1	responders	3.0	33	not stated; randomized; registry:outcomes
26	A2	responders	33.3	66	not stated; randomized; registry:outcomes
26	A3	responders	45.5	66	not stated; randomized; registry:outcomes
26	A4	responders	35.9	64	not stated; randomized; registry:outcomes
26	A5	responders	40.3	67	not stated; randomized; registry:outcomes

Weight loss of 10 percent or more (5 lines; O11B)

Week	Arm	Statistic	Estimate	Events / N	Detail
26	A1	responders	0.0	33	not stated; randomized; registry:outcomes
26	A2	responders	12.1	66	not stated; randomized; registry:outcomes
26	A3	responders	13.6	66	not stated; randomized; registry:outcomes
26	A4	responders	15.6	64	not stated; randomized; registry:outcomes
26	A5	responders	9.0	67	not stated; randomized; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 33	not stated; safety; registry:adverse_events
	A5	events				0 / 67	not stated; safety; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 33	not stated; safety; registry:adverse_events
	A5	events				2 / 67	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (5 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 33	not stated; randomized; registry:flow
A2	events	10 / 66	not stated; randomized; registry:flow
A3	events	11 / 66	not stated; randomized; registry:flow
A4	events	13 / 64	not stated; randomized; registry:flow
A5	events	3 / 67	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 33	not stated; safety; registry:adverse_events
	A5	events				21 / 67	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 33	not stated; safety; registry:adverse_events
	A5	events				1 / 67	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 33	not stated; safety; registry:adverse_events
	A5	events				8 / 67	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 33	not stated; safety; registry:adverse_events
	A5	events				2 / 67	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 33	not stated; safety; cholecystitis acute; registry:adverse_events
	A5	events				0 / 67	not stated; safety; cholecystitis acute; registry:adverse_events

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 33	not stated; safety; pancreatic carcinoma; registry:adverse_events
	A5	events				0 / 67	not stated; safety; pancreatic carcinoma; registry:adverse_events