parallel randomized trial

NCT01733758

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

Type 2 diabetes (adults)NCT01733758S001075

Design

Randomized: 494
Start year: 2013
Treatment: 52 weeks, follow-up 60 weeks
Countries: Japan (75 sites)
Sponsor: GlaxoSmithKline (industry)
Eligibility: Japanese adults; diet and exercise with or without one oral drug; HbA1c 7 to 10 percent after washout

Conduct and analysis

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

Arms

Arm	Treatment	Background	Analyzed
A1	Placebo Placebo	lifestyle: not reported	77
A2	Albiglutide 30 mg subcutaneous once weekly Albiglutide 30 mg weekly	lifestyle: not reported	159
A3	Albiglutide 50 mg subcutaneous once weekly Albiglutide 50 mg weekly	lifestyle: not reported	150
A4	Liraglutide 0.9 mg injection once daily Liraglutide 0.9 mg daily open label	lifestyle: not reported	103

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	Liraglutide 0.9 mg injection once daily A4
age	mean (years)	57.3	59.6	57.7	58.4
age	sd (years)	11.27	9.00	9.51	9.72
asian	n	77	160	150	103
bmi	mean (kg/m2)	25.6	25.3	26.1	26.3
bmi	sd (kg/m2)	3.42	4.17	3.66	4.35
diabetes duration	mean (years)	6.7	7.2	6.9	5.8
diabetes duration	sd (years)	5.38	6.22	6.21	4.37
female	n	25	35	36	22
hba1c	mean (percent)	8.16	8.07	8.15	8.07
hba1c	sd (percent)	0.88	0.78	0.83	0.79
other prior oad	n	28	61	55	38
other prior oad	percent	36.4	38.1	36.7	36.9
weight	mean (kg)	68.7	69.3	71.5	72.7
weight	sd (kg)	12.09	13.53	12.91	13.76

Analyses this trial contributes to

Results

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

HbA1c change (14 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	0.25 percent	0.068		77	not stated; modified itt; registry:outcomes
24	A1	change	0.24 percent	0.715		77	not stated; modified itt; registry:outcomes
24	A2	change	-1.10 percent	0.047		159	not stated; modified itt; registry:outcomes
24	A2	change	-1.08 percent	0.619		159	not stated; modified itt; registry:outcomes
24	A2 vs A1	md	-1.35 percent		-1.51 to -1.18		not stated; modified itt; registry:outcomes
24	A3	change	-1.30 percent	0.049		150	not stated; modified itt; registry:outcomes
24	A3	change	-1.32 percent	0.702		150	not stated; modified itt; registry:outcomes
24	A3 vs A1	md	-1.55 percent		-1.72 to -1.39		not stated; modified itt; registry:outcomes
24	A4	change	-1.19 percent	0.636		103	not stated; modified itt; registry:outcomes
52	A2	change	-1.07 percent	0.790		148	not stated; completers; registry:outcomes
52	A2	change	-1.10 percent	0.05			not stated; modified itt; R0010997:Results
52	A3	change	-1.34 percent	0.753		135	not stated; completers; registry:outcomes
52	A3	change	-1.30 percent	0.06			not stated; modified itt; R0010997:Results
52	A4	change	-1.17 percent	0.776		95	not stated; completers; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	change	-0.50 kg	1.700	77	not stated; modified itt; registry:outcomes
24	A2	change	0.32 kg	1.795	159	not stated; modified itt; registry:outcomes
24	A3	change	-0.04 kg	1.976	150	not stated; modified itt; registry:outcomes
24	A4	change	-0.34 kg	2.587	103	not stated; modified itt; registry:outcomes
52	A2	change	0.08 kg	2.078	148	not stated; completers; registry:outcomes
52	A3	change	-0.31 kg	2.382	135	not stated; completers; registry:outcomes
52	A4	change	-0.50 kg	2.690	95	not stated; completers; registry:outcomes

HbA1c below 7 percent (7 lines; O03)

Week	Arm	Statistic	Events / N	Detail
24	A1	responders	4 / 77	not stated; modified itt; registry:outcomes
24	A2	responders	92 / 159	not stated; modified itt; registry:outcomes
24	A3	responders	100 / 150	not stated; modified itt; registry:outcomes
24	A4	responders	66 / 103	not stated; modified itt; registry:outcomes
52	A2	responders	82 / 148	not stated; completers; registry:outcomes
52	A3	responders	85 / 135	not stated; completers; registry:outcomes
52	A4	responders	57 / 95	not stated; completers; registry:outcomes

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

Arm	Statistic	Events / N	Detail
A1	events	2 / 77	not stated; safety; R0010997:Results
A2	events	8 / 160	not stated; safety; R0010997:Results
A3	events	6 / 150	not stated; safety; R0010997:Results
A4	events	3 / 103	not stated; safety; R0010997:Results

Acute kidney injury (4 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	0 / 77	not stated; safety; acute renal failure; R0010997:Results
A2	events	0 / 160	not stated; safety; acute renal failure; R0010997:Results
A3	events	1 / 150	not stated; safety; acute renal failure; R0010997:Results
A4	events	0 / 103	not stated; safety; acute renal failure; R0010997:Results

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 77	not stated; safety; R0010997:Results
A2	events	2 / 160	not stated; safety; R0010997:Results
A3	events	1 / 150	not stated; safety; R0010997:Results
A4	events	0 / 103	not stated; safety; R0010997:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 77	not stated; safety; R0010997:Table 2
A2	events	5 / 160	not stated; safety; R0010997:Table 2
A3	events	6 / 150	not stated; safety; R0010997:Table 2
A4	events	0 / 103	not stated; safety; R0010997:Table 2

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	3 / 77	not stated; safety; R0010997:Table 2
A2	events	7 / 160	not stated; safety; R0010997:Table 2
A3	events	8 / 150	not stated; safety; R0010997:Table 2
A4	events	1 / 103	not stated; safety; R0010997:Table 2

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	4 / 77	not stated; safety; R0010997:Table 3
A2	events	2 / 160	not stated; safety; R0010997:Table 3
A3	events	10 / 150	not stated; safety; R0010997:Table 3
A4	events	4 / 103	not stated; safety; R0010997:Table 3

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	4 / 77	not stated; safety; R0010997:Table 3
A2	events	2 / 160	not stated; safety; R0010997:Table 3
A3	events	8 / 150	not stated; safety; R0010997:Table 3
A4	events	5 / 103	not stated; safety; R0010997:Table 3

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	3 / 77	not stated; safety; R0010997:Table 3
A2	events	14 / 160	not stated; safety; R0010997:Table 3
A3	events	17 / 150	not stated; safety; R0010997:Table 3
A4	events	7 / 103	not stated; safety; R0010997:Table 3

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 77	not stated; safety; cholecystitis; R0010997:Results
A2	events	1 / 160	not stated; safety; cholecystitis; R0010997:Results
A3	events	0 / 150	not stated; safety; cholecystitis; R0010997:Results
A4	events	0 / 103	not stated; safety; cholecystitis; R0010997:Results

Pancreatic cancer (4 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	0 / 77	not stated; safety; pancreatic cancer; R0010997:Results
A2	events	1 / 160	not stated; safety; pancreatic cancer; R0010997:Results
A3	events	0 / 150	not stated; safety; pancreatic cancer; R0010997:Results
A4	events	0 / 103	not stated; safety; pancreatic cancer; R0010997:Results