parallel randomized trial

NCT00838916

A Randomized, Open-label, Parallel-group, Multicenter Study to Determine the Efficacy and Long-term Safety of Albiglutide Compared With Insulin in Subjects With Type 2 Diabetes Mellitus.

Type 2 diabetes (adults)NCT00838916S000099

Design

Randomized: 779
Start year: 2009
Treatment: 156 weeks, follow-up 164 weeks
Countries: United States, Russia, South Africa, United Kingdom (222 sites)
Sponsor: GlaxoSmithKline (industry)
Eligibility: age 18 or older, HbA1c 7.0 to 10.0 percent, BMI 20 to 45, creatinine clearance above 60

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: hypothetical
Analysis population: modified itt
Missing data: LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Albiglutide flexible dose injection once weekly Albiglutide 30 mg, uptitration to 50 mg allowed	metformin with or without sulfonylurea; lifestyle: not reported	516	496
A2	Insulin glargine Insulin glargine titrated	metformin with or without SU; lifestyle: not reported	263	239

Baseline characteristics

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

Characteristic	Statistic	Albiglutide flexible dose injection once weekly A1	Insulin glargine A2
age	mean (years)	55.8	54.7
age	sd (years)	9.3	9.8
asian: central south asian	n	7	5
asian: east asian	n	2	1
asian: japanese	n	0	1
asian: southeast asian	n	16	8
black	n	130	64
black	percent	25.8	26.6
bmi	mean (kg/m2)	33.2	33.0
bmi	sd (kg/m2)	5.6	5.4
diabetes duration	mean (years)	8.9	8.4
diabetes duration	sd (years)	6.5	5.7
established cvd: myocardial infarction	n	26	11
established cvd: myocardial infarction	percent	5.2	4.6
female	n	218	109
female	percent	43.3	45.2
hba1c	mean (percent)	8.28	8.36
hba1c	sd (percent)	0.90	0.95
hispanic	n	81	38
hispanic	percent	16.1	15.8
other american indian alaska native	n	3	1
other background metformin only	percent	18.1	18.3
other background metformin su	percent	81.9	81.7
other pacific islander	n	1	0
other prior mi	n	26	11
other prior mi	percent	5.2	4.6
sbp	mean (mmHg)	130.3	131.6
sbp	sd (mmHg)	14.0	14.0
weight	mean (kg)	95.1	94.6
weight	sd (kg)	19.7	19.1
white: white arabic north african	n	7	2
white: white european	n	342	158
white: white european	percent	67.9	65.6

Analyses this trial contributes to

Results

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

HbA1c change (9 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	final	7.62 percent	1.12		496	hypothetical; modified itt; R0025374:Results
52	A1 vs A2	md	0.11 percent		-0.04 to 0.27		hypothetical; modified itt; R0025374:p4
52	A1	change	-0.67 percent			496	hypothetical; modified itt; R0025374:p4
52	A1	change	-0.67 percent	0.044		493	hypothetical; modified itt; registry:outcomes
52	A2	final	7.55 percent	1.04		239	hypothetical; modified itt; R0025374:Results
52	A2	change	-0.79 percent			239	hypothetical; modified itt; R0025374:p4
52	A2	change	-0.79 percent	0.064		238	hypothetical; modified itt; registry:outcomes
156	A1	change	-0.83 percent	0.980		123	not stated; modified itt; registry:outcomes
156	A2	change	-1.00 percent	0.922		88	not stated; modified itt; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1 vs A2	md	-2.61 kg		-3.20 to -2.02		hypothetical; modified itt; R0025374:p4
52	A1	change	-1.06 kg	3.80		496	hypothetical; modified itt; R0025374:p4
52	A1	change	-1.05 kg	0.171		495	hypothetical; modified itt; registry:outcomes
52	A2	change	1.56 kg	0.247		238	hypothetical; modified itt; registry:outcomes
52	A2	change	1.57 kg	3.81		239	hypothetical; modified itt; R0025374:p4
156	A1	change	-3.47 kg	6.300		122	hypothetical; modified itt; registry:outcomes
156	A2	change	0.90 kg	4.890		89	hypothetical; modified itt; registry:outcomes

HbA1c below 7 percent (6 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
52	A1	responders		156 / 493	hypothetical; modified itt; registry:outcomes
52	A1	responders	31.6	496	hypothetical; modified itt; R0025374:Results
52	A2	responders	32.8	239	hypothetical; modified itt; R0025374:Results
52	A2	responders		78 / 238	hypothetical; modified itt; registry:outcomes
156	A1	responders		59 / 123	hypothetical; modified itt; registry:outcomes
156	A2	responders		46 / 88	hypothetical; modified itt; registry:outcomes

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

Arm	Statistic	Events / N	Detail
A1	events	2 / 504	hypothetical; safety; R0025374:Table 3
A1	events	88 / 504	hypothetical; safety; R0025374:Table 3
A2	events	1 / 241	hypothetical; safety; R0025374:Table 3
A2	events	66 / 241	hypothetical; safety; R0025374:Table 3

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	change	-1.4 mmHg	14.4			not stated; modified itt; R0025374:p8
52	A2	change	0.3 mmHg	13.7			not stated; modified itt; R0025374:p8

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 504	not stated; safety; renal failure acute; registry:adverse_events
	A2	events				1 / 241	not stated; safety; renal failure acute; registry:adverse_events

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 504	not stated; safety; R0025374:p5
	A2	events				3 / 241	not stated; safety; R0025374:p5

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	92 / 504	not stated; safety; registry:adverse_events
A1	events	42 / 504	not stated; safety; R0025374:Table 2
A2	events	20 / 241	not stated; safety; R0025374:Table 2
A2	events	46 / 241	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	32 / 504	not stated; safety; R0025374:Figure 1
A1	events	50 / 504	not stated; safety; registry:flow
A1	events	35 / 504	not stated; safety; R0025374:Table 2
A2	events	11 / 241	not stated; safety; registry:flow
A2	events	6 / 241	not stated; safety; R0025374:Table 2
A2	events	6 / 241	not stated; safety; R0025374:Figure 1

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	50 / 504	not stated; safety; R0025374:Table 2
A1	events	67 / 504	not stated; safety; registry:adverse_events
A2	events	18 / 241	not stated; safety; registry:adverse_events
A2	events	9 / 241	not stated; safety; R0025374:Table 2

Vomiting (4 lines; O27B)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	3.8	504	not stated; safety; R0025374:p5
A1	events		27 / 504	not stated; safety; registry:adverse_events
A2	events		13 / 241	not stated; safety; registry:adverse_events
A2	events	3.7	241	not stated; safety; R0025374:p5

Diarrhea (6 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	55 / 504	not stated; safety; registry:adverse_events
A1	events	1 / 504	not stated; safety; registry:adverse_events
A1	events	38 / 504	not stated; safety; R0025374:Table 2
A2	events	0 / 241	not stated; safety; registry:adverse_events
A2	events	19 / 241	not stated; safety; registry:adverse_events
A2	events	10 / 241	not stated; safety; R0025374:Table 2

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				29 / 504	not stated; safety; registry:adverse_events
	A2	events				4 / 241	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 504	not stated; safety; cholelithiasis; registry:adverse_events
A1	events	0 / 504	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	0 / 241	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	3 / 241	not stated; safety; cholecystitis acute; registry:adverse_events

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 504	not stated; safety; R0025374:p6
A1	events	1 / 504	not stated; safety; pancreatitis; registry:adverse_events
A2	events	0 / 241	not stated; safety; pancreatitis; registry:adverse_events
A2	events	0 / 241	not stated; safety; R0025374:p6

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 504	not stated; safety; R0025374:p6
	A2	events				0 / 241	not stated; safety; R0025374:p6

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 504	not stated; safety; R0025374:p6
	A2	events				0 / 241	not stated; safety; R0025374:p6