parallel randomized trial

NCT02465515

A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT02465515S001074

Design

Randomized: 9,463
Start year: 2015
Treatment: , follow-up 140.89 weeks
Countries
Sponsor: GlaxoSmithKline (industry)
Eligibility: type 2 diabetes with established cardiovascular disease

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	standard care glucose lowering and cardiovascular therapy; lifestyle: not reported	4,732	4,732
A2	Albiglutide flexible dose injection once weekly Albiglutide 30 to 50 mg	standard glucose lowering and cardiovascular care; lifestyle: not reported	4,731	4,731

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Albiglutide flexible dose injection once weekly A2	Whole trial ALL
age	mean (years)	64.2	64.1
age	sd (years)	8.65	8.71
asian: central south asian	n	27	25
asian: east or southeast asian	n	215	204
black	n	118	121
bmi	mean (kg/m2)			32.3
bmi	sd (kg/m2)			5.9
diabetes duration	mean (years)			14.2
diabetes duration	sd (years)			8.8
established cvd	percent			100
female	n	1467	1427
hba1c	mean (percent)			8.7
hba1c	sd (percent)			1.5
other american indian alaska native	n	238	280
other american indian and black	n	1	3
other american indian and white	n	24	20
other asian and black	n	1	0
other asian and white	n	0	1
other black and white	n	81	67
other native hawaiian pacific islander	n	2	3
other race unknown	n	1	1
white	n	4024	4006

Analyses this trial contributes to

Results

95 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
34.76	A1	change	-0.28 percent	0.020		4211	not stated; randomized; registry:outcomes
34.76	A2	change	-0.92 percent	0.019		4289	not stated; randomized; registry:outcomes
34.76	A2 vs A1	md	-0.63 percent		-0.69 to -0.58		not stated; randomized; registry:outcomes
69.52	A1	change	-0.31 percent	0.023		3066	not stated; randomized; registry:outcomes
69.52	A2 vs A1	md	-0.52 percent		-0.58 to -0.45		not stated; randomized; registry:outcomes
69.52	A2	change	-0.83 percent	0.022		3163	not stated; randomized; registry:outcomes

Body weight change in kilograms (diabetes) (6 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
34.76	A1	change	-0.36 kg	0.062		4217	not stated; randomized; registry:outcomes
34.76	A2	change	-1.02 kg	0.061		4286	not stated; randomized; registry:outcomes
34.76	A2 vs A1	md	-0.66 kg		-0.83 to -0.49		not stated; randomized; registry:outcomes
69.52	A1	change	-0.53 kg	0.084		3068	not stated; randomized; registry:outcomes
69.52	A2 vs A1	md	-0.83 kg		-1.06 to -0.60		not stated; randomized; registry:outcomes
69.52	A2	change	-1.36 kg	0.083		3173	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				55 / 4715	not stated; safety; registry:outcomes
	A2	events				31 / 4717	not stated; safety; registry:outcomes

Systolic blood pressure change (8 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
34.76	A1	change	-0.5 mmHg	17.33	4241	not stated; safety; registry:outcomes
34.76	A2	change	-1.0 mmHg	16.80	4319	not stated; safety; registry:outcomes
69.52	A1	change	-0.5 mmHg	17.45	3082	not stated; safety; registry:outcomes
69.52	A2	change	-0.9 mmHg	17.58	3187	not stated; safety; registry:outcomes
104.28	A1	change	-0.9 mmHg	18.62	1133	not stated; safety; registry:outcomes
104.28	A2	change	-1.2 mmHg	17.51	1198	not stated; safety; registry:outcomes
140.89	A1	change	0.0 mmHg	17.68	3897	not stated; safety; registry:outcomes
140.89	A2	change	-0.4 mmHg	17.58	4015	not stated; safety; registry:outcomes

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				47 / 4715	not stated; safety; Acute kidney injury; registry:adverse_events
	A2	events				42 / 4717	not stated; safety; Acute kidney injury; registry:adverse_events

All cause mortality (3 lines; O20)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			205 / 4732	not stated; randomized; registry:adverse_events
A2	events			196 / 4731	not stated; randomized; registry:adverse_events
A2 vs A1	hr	0.95	0.79 to 1.16		not stated; randomized; registry:outcomes

Three point MACE (1 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2 vs A1	hr	0.78		0.68 to 0.90		not stated; randomized; registry:outcomes

Four point MACE including unstable angina (1 lines; O21B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2 vs A1	hr	0.78		0.69 to 0.90		not stated; randomized; registry:outcomes

Health related quality of life total score (any instrument) (12 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
34.76	A1	change	1.36 points	0.217		3982	not stated; randomized; registry:outcomes
34.76	A1	change	4.53 points	0.194		3013	not stated; randomized; registry:outcomes
34.76	A2	change	2.83 points	0.216		4014	not stated; randomized; registry:outcomes
34.76	A2	change	6.92 points	0.193		3041	not stated; randomized; registry:outcomes
34.76	A2 vs A1	md	1.47 points		0.87 to 2.07		not stated; randomized; registry:outcomes
34.76	A2 vs A1	md	2.39 points		1.85 to 2.93		not stated; randomized; registry:outcomes
69.52	A1	change	1.87 points	0.287		2347	not stated; randomized; registry:outcomes
69.52	A1	change	4.80 points	0.247		1738	not stated; randomized; registry:outcomes
69.52	A2 vs A1	md	0.52 points		-0.26 to 1.31		not stated; randomized; registry:outcomes
69.52	A2	change	2.39 points	0.279		2481	not stated; randomized; registry:outcomes
69.52	A2	change	7.13 points	0.241		1840	not stated; randomized; registry:outcomes
69.52	A2 vs A1	md	2.33 points		1.66 to 3.01		not stated; randomized; registry:outcomes

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1022 / 4715	not stated; safety; registry:adverse_events
A1	events	974 / 4715	not stated; safety; registry:outcomes
A2	events	891 / 4717	not stated; safety; registry:outcomes
A2	events	932 / 4717	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				334 / 4715	not stated; safety; registry:outcomes
	A2	events				427 / 4717	not stated; safety; registry:outcomes

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 4715	not stated; safety; Nausea; registry:adverse_events
	A2	events				2 / 4717	not stated; safety; Nausea; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 4715	not stated; safety; Vomiting; registry:adverse_events
	A2	events				5 / 4717	not stated; safety; Vomiting; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 4715	not stated; safety; Diarrhoea; registry:adverse_events
	A2	events				4 / 4717	not stated; safety; Diarrhoea; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 4715	not stated; safety; Constipation; registry:adverse_events
	A2	events				3 / 4717	not stated; safety; Constipation; registry:adverse_events

Gallbladder and biliary disease (16 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	4 / 4715	not stated; safety; Cholecystitis acute; registry:adverse_events
A1	events	0 / 4715	not stated; safety; Cholecystitis infective; registry:adverse_events
A1	events	5 / 4715	not stated; safety; Cholecystitis; registry:adverse_events
A1	events	1 / 4715	not stated; safety; Bile duct stone; registry:adverse_events
A1	events	1 / 4715	not stated; safety; Biliary ascites; registry:adverse_events
A1	events	0 / 4715	not stated; safety; Biliary colic; registry:adverse_events
A1	events	7 / 4715	not stated; safety; Cholelithiasis; registry:adverse_events
A1	events	2 / 4715	not stated; safety; Cholecystitis chronic; registry:adverse_events
A2	events	2 / 4717	not stated; safety; Bile duct stone; registry:adverse_events
A2	events	0 / 4717	not stated; safety; Biliary ascites; registry:adverse_events
A2	events	2 / 4717	not stated; safety; Biliary colic; registry:adverse_events
A2	events	7 / 4717	not stated; safety; Cholecystitis acute; registry:adverse_events
A2	events	0 / 4717	not stated; safety; Cholecystitis chronic; registry:adverse_events
A2	events	1 / 4717	not stated; safety; Cholecystitis infective; registry:adverse_events
A2	events	7 / 4717	not stated; safety; Cholecystitis; registry:adverse_events
A2	events	12 / 4717	not stated; safety; Cholelithiasis; registry:adverse_events

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	7 / 4715	not stated; safety; registry:outcomes
A1	events	13 / 4715	not stated; safety; registry:outcomes
A2	events	10 / 4717	not stated; safety; registry:outcomes
A2	events	14 / 4717	not stated; safety; registry:outcomes

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 4715	not stated; safety; registry:outcomes
	A2	events				0 / 4717	not stated; safety; registry:outcomes

Diabetic retinopathy complications (2 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				89 / 4715	not stated; safety; registry:outcomes
	A2	events				78 / 4717	not stated; safety; registry:outcomes

Suicidal ideation or behavior (4 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 4715	not stated; safety; Suicidal ideation; registry:adverse_events
A1	events	2 / 4715	not stated; safety; Suicide attempt; registry:adverse_events
A2	events	1 / 4717	not stated; safety; Suicidal ideation; registry:adverse_events
A2	events	1 / 4717	not stated; safety; Suicide attempt; registry:adverse_events

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 4715	not stated; safety; Completed suicide; registry:adverse_events
	A2	events				1 / 4717	not stated; safety; Completed suicide; registry:adverse_events

Gastroparesis (2 lines; O37A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 4715	not stated; safety; Diabetic gastroparesis; registry:adverse_events
	A2	events				1 / 4717	not stated; safety; Diabetic gastroparesis; registry:adverse_events

Intestinal obstruction or ileus (6 lines; O37B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 4715	not stated; safety; Intestinal obstruction; registry:adverse_events
A1	events	0 / 4715	not stated; safety; Ileus; registry:adverse_events
A1	events	5 / 4715	not stated; safety; Small intestinal obstruction; registry:adverse_events
A2	events	2 / 4717	not stated; safety; Intestinal obstruction; registry:adverse_events
A2	events	1 / 4717	not stated; safety; Ileus; registry:adverse_events
A2	events	5 / 4717	not stated; safety; Small intestinal obstruction; registry:adverse_events

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 4715	not stated; safety; registry:outcomes
	A2	events				6 / 4717	not stated; safety; registry:outcomes