parallel randomized trial

NCT00849017

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Two Dose Levels of Albiglutide Compared With Placebo in Subjects With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT00849017S000852

Design

Randomized: 309
Start year: 2009
Treatment: 156 weeks, follow-up 164 weeks
Countries: United States, Mexico (143 sites)
Sponsor: GlaxoSmithKline (industry)
Eligibility: age 18 or older; HbA1c 7.0 to 10.0 percent; BMI 20 to 45; diet and exercise only

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
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	Placebo Placebo	diet and exercise; lifestyle: standard	105	98	58
A2	Albiglutide 30 mg subcutaneous once weekly Albiglutide 30 mg	diet and exercise; lifestyle: standard	102	100	68
A3	Albiglutide 50 mg subcutaneous once weekly Albiglutide 50 mg	diet and exercise; lifestyle: standard	102	97	57

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Albiglutide 30 mg subcutaneous once weekly A2	Albiglutide 50 mg subcutaneous once weekly A3
age	mean (years)	53.1	53.6	52.0
age	sd (years)	11.7	10.9	11.8
asian	n	5	1	1
asian	percent	5.0	1.0	1.0
black	n	14	10	14
black	percent	13.9	9.9	14.1
bmi	mean (kg/m2)	33.00	33.7	33.9
bmi	sd (kg/m2)	5.4	5.1	5.5
diabetes duration	mean (years)	4.3	3.4	4.2
diabetes duration	sd (years)	4.0	3.7	4.6
established cvd: previous mi	n	4	3	2
established cvd: previous mi	percent	4.0	3.0	2.0
hba1c	mean (percent)	8.0	8.0	8.2
hba1c	sd (percent)	0.9	0.8	0.9
hispanic	n	29	30	26
hispanic	percent	28.7	29.7	26.3
other male	n	58	58	50
other male	percent	57.4	57.4	50.5
other prior mi	n	4	3	2
other prior mi	percent	4.0	3.0	2.0
weight	mean (kg)	95.4	95.8	97.10
weight	sd (kg)	19.9	19.6	17.8
white	n	79	85	78
white	percent	78.2	84.2	78.8

Analyses this trial contributes to

Results

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

HbA1c change (11 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	change	0.15 percent	0.097		98	hypothetical; modified itt; registry:outcomes
52	A2 vs A1	md	-0.84 percent		-1.11 to -0.58		hypothetical; modified itt; R0022386:Results
52	A2	change	-0.70 percent	0.096		100	hypothetical; modified itt; registry:outcomes
52	A3 vs A1	md	-1.04 percent		-1.31 to -0.77		hypothetical; modified itt; R0022386:Results
52	A3	change	-0.89 percent	0.097		97	hypothetical; modified itt; registry:outcomes
104	A1	change	-0.40 percent	0.676		21	not stated; modified itt; registry:outcomes
104	A2	change	-0.93 percent	1.027		39	not stated; modified itt; registry:outcomes
104	A3	change	-1.18 percent	0.909		42	not stated; modified itt; registry:outcomes
156	A1	change	-0.61 percent	0.644		14	not stated; modified itt; registry:outcomes
156	A2	change	-0.96 percent	0.968		30	not stated; modified itt; registry:outcomes
156	A3	change	-1.07 percent	0.887		32	not stated; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (9 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
52	A1	change	-0.66 kg		99	hypothetical; modified itt; R0022386:Results
52	A1	change	-0.66 kg	0.428	99	hypothetical; modified itt; registry:outcomes
52	A2	change	-0.39 kg		100	hypothetical; modified itt; R0022386:Results
52	A2	change	-0.39 kg	0.424	100	hypothetical; modified itt; registry:outcomes
52	A3	change	-0.86 kg		97	hypothetical; modified itt; R0022386:Results
52	A3	change	-0.86 kg	0.432	97	hypothetical; modified itt; registry:outcomes
156	A1	change	-2.91 kg	5.213	14	hypothetical; modified itt; registry:outcomes
156	A2	change	-1.32 kg	5.123	30	hypothetical; modified itt; registry:outcomes
156	A3	change	-2.24 kg	5.589	31	hypothetical; modified itt; registry:outcomes

HbA1c below 7 percent (6 lines; O03)

Week	Arm	Statistic	Events / N	Detail
52	A1	responders	21 / 98	hypothetical; modified itt; registry:outcomes
52	A2	responders	49 / 100	hypothetical; modified itt; registry:outcomes
52	A3	responders	39 / 97	hypothetical; modified itt; registry:outcomes
156	A1	responders	8 / 14	hypothetical; modified itt; registry:outcomes
156	A2	responders	18 / 30	hypothetical; modified itt; registry:outcomes
156	A3	responders	19 / 32	hypothetical; modified itt; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 101	hypothetical; safety; R0022386:Table 2
A1	events	8 / 101	while on treatment; safety; registry:adverse_events
A2	events	6 / 101	while on treatment; safety; registry:adverse_events
A2	events	0 / 101	hypothetical; safety; R0022386:Table 2
A3	events	0 / 99	hypothetical; safety; R0022386:Table 2
A3	events	9 / 99	while on treatment; safety; registry:adverse_events

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 101	not stated; safety; R0022386:Results
A2	events	0 / 101	not stated; safety; R0022386:Results
A3	events	3 / 99	not stated; safety; R0022386:Results

Serious adverse events (6 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	16 / 101	while on treatment; safety; registry:adverse_events
A1	events	8 / 101	while on treatment; safety; R0022386:Table 2
A2	events	11 / 101	while on treatment; safety; R0022386:Table 2
A2	events	15 / 101	while on treatment; safety; registry:adverse_events
A3	events	14 / 99	while on treatment; safety; registry:adverse_events
A3	events	10 / 99	while on treatment; safety; R0022386:Table 2

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	5 / 101	not stated; randomized; registry:flow
A1	events	2 / 101	while on treatment; safety; R0022386:Table 2
A2	events	6 / 101	not stated; randomized; registry:flow
A2	events	5 / 101	while on treatment; safety; R0022386:Table 2
A3	events	13 / 99	while on treatment; safety; R0022386:Table 2
A3	events	15 / 99	not stated; randomized; registry:flow

Nausea (6 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	10 / 101	while on treatment; safety; registry:adverse_events
A1	events	8 / 101	while on treatment; safety; R0022386:Table 2
A2	events	14 / 101	while on treatment; safety; registry:adverse_events
A2	events	10 / 101	while on treatment; safety; R0022386:Table 2
A3	events	11 / 99	while on treatment; safety; registry:adverse_events
A3	events	9 / 99	while on treatment; safety; R0022386:Table 2

Vomiting (9 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 101	while on treatment; safety; registry:adverse_events
A1	events	1 / 101	while on treatment; safety; R0022386:Table 2
A1	events	0 / 101	while on treatment; safety; registry:adverse_events
A2	events	0 / 101	while on treatment; safety; registry:adverse_events
A2	events	4 / 101	while on treatment; safety; registry:adverse_events
A2	events	3 / 101	while on treatment; safety; R0022386:Table 2
A3	events	4 / 99	while on treatment; safety; registry:adverse_events
A3	events	1 / 99	while on treatment; safety; registry:adverse_events
A3	events	3 / 99	while on treatment; safety; R0022386:Table 2

Diarrhea (6 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	15 / 101	while on treatment; safety; registry:adverse_events
A1	events	12 / 101	while on treatment; safety; R0022386:Table 2
A2	events	13 / 101	while on treatment; safety; registry:adverse_events
A2	events	10 / 101	while on treatment; safety; R0022386:Table 2
A3	events	16 / 99	while on treatment; safety; registry:adverse_events
A3	events	13 / 99	while on treatment; safety; R0022386:Table 2

Constipation (6 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	3 / 101	while on treatment; safety; R0022386:Table 2
A1	events	4 / 101	while on treatment; safety; registry:adverse_events
A2	events	3 / 101	while on treatment; safety; registry:adverse_events
A2	events	2 / 101	while on treatment; safety; R0022386:Table 2
A3	events	6 / 99	while on treatment; safety; registry:adverse_events
A3	events	3 / 99	while on treatment; safety; R0022386:Table 2

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A3	events				3 / 99	while on treatment; safety; R0022386:Results

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 101	not stated; safety; R0022386:Results
A2	events	0 / 101	not stated; safety; R0022386:Results
A3	events	0 / 99	not stated; safety; R0022386:Results

Medullary thyroid carcinoma (3 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 101	not stated; safety; R0022386:Results
A2	events	0 / 101	not stated; safety; R0022386:Results
A3	events	0 / 99	not stated; safety; R0022386:Results

Thyroid cancer (any) (3 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 101	not stated; safety; R0022386:Results
A2	events	0 / 101	not stated; safety; R0022386:Results
A3	events	0 / 99	not stated; safety; R0022386:Results

Diabetic retinopathy complications (3 lines; O33)

Arm	Statistic	Events / N	Detail
A1	events	1 / 101	while on treatment; safety; diabetic retinopathy; registry:adverse_events
A2	events	4 / 101	while on treatment; safety; diabetic retinopathy; registry:adverse_events
A3	events	1 / 99	while on treatment; safety; diabetic retinopathy; registry:adverse_events

Suicidal ideation or behavior (3 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 101	while on treatment; safety; suicidal ideation; registry:adverse_events
A2	events	1 / 101	while on treatment; safety; suicidal ideation; registry:adverse_events
A3	events	0 / 99	while on treatment; safety; suicidal ideation; registry:adverse_events

Pancreatic cancer (3 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	0 / 101	while on treatment; safety; pancreatic carcinoma metastatic; registry:adverse_events
A2	events	0 / 101	while on treatment; safety; pancreatic carcinoma metastatic; registry:adverse_events
A3	events	1 / 99	while on treatment; safety; pancreatic carcinoma metastatic; registry:adverse_events