parallel randomized trial

NCT00518115

A 16-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Multiple Doses and Multiple Treatment Regimens of GSK716155, With Byetta as an Open Label Active Reference, in Subjects With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT00518115S000060

Design

Randomized: 361
Start year: 2007
Treatment: 16 weeks, follow-up 27 weeks
Countries: United States, Mexico, Chile, Dominican Republic (118 sites)
Sponsor: GlaxoSmithKline (industry)
Eligibility: age 18 to 75; BMI 20 to 40; HbA1c 7 to 10 percent; drug naive or metformin

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	diet and exercise or metformin; lifestyle: not reported	52	50
A10	Albiglutide 100 mg injection every 4 weeks Albiglutide 100 mg monthly	diet and exercise or metformin; lifestyle: not reported	35	33
A2	Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug twice daily	metformin; lifestyle: not reported	35	34
A3	Albiglutide 4 mg injection once weekly Albiglutide 4 mg weekly	diet and exercise or metformin; lifestyle: not reported	36	34
A4	Albiglutide 15 mg injection once weekly Albiglutide 15 mg weekly	diet and exercise or metformin; lifestyle: not reported	35	34
A5	Albiglutide 30 mg subcutaneous once weekly Albiglutide 30 mg weekly	diet and exercise or metformin; lifestyle: not reported	31	29
A6	Albiglutide 15 mg injection every 2 weeks Albiglutide 15 mg every 2 weeks	diet and exercise or metformin; lifestyle: not reported	34	30
A7	Albiglutide 30 mg injection every 2 weeks Albiglutide 30 mg every 2 weeks	diet and exercise or metformin; lifestyle: not reported	33	32
A8	Albiglutide 50 mg injection every 2 weeks Albiglutide 50 mg every 2 weeks	diet and exercise or metformin; lifestyle: not reported	35	34
A9	Albiglutide 50 mg injection every 4 weeks Albiglutide 50 mg monthly	diet and exercise or metformin; lifestyle: not reported	35	35

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Exenatide 10 ug subcutaneous twice daily A2	Albiglutide 4 mg injection once weekly A3	Albiglutide 15 mg injection once weekly A4	Albiglutide 30 mg subcutaneous once weekly A5	Albiglutide 15 mg injection every 2 weeks A6	Albiglutide 30 mg injection every 2 weeks A7	Albiglutide 50 mg injection every 2 weeks A8	Albiglutide 50 mg injection every 4 weeks A9	Albiglutide 100 mg injection every 4 weeks A10	Whole trial ALL
age	mean (years)	54.0	53.7	50.4	55.5	54.2	52.5	55.5	51.1	54.1	54.4
age	sd (years)	10.62	9.38	10.25	10.48	9.66	9.55	9.87	10.25	11.30	9.89
black	n	8	10	7	4	3	3	5	4	6	5
bmi	mean (kg/m2)											32.1
diabetes duration	mean (years)											4.9
female	n	23	19	20	17	23	19	16	16	18	15
hba1c	mean (percent)	7.8	8.0	8.2	8.0	8.0	8.2	8.0	7.9	7.9	8.1
hba1c	sd (percent)	0.9	0.9	1.0	0.9	0.9	1.0	1.0	0.7	0.8	1.0
hispanic	n	3	0	4	7	2	3	5	5	4	4
other race american indian alaska native	n	0	0	0	0	1	1	1	1	1	0
other race central south asian	n	0	1	0	1	0	0	4	1	1	1
other race east asian	n	2	0	1	0	1	1	1	1	1	0
other race hispanic puerto rican	n	0	0	0	0	0	0	0	0	1	0
other race japanese	n	0	1	0	0	0	0	0	0	0	0
other race mestizo	n	0	0	1	0	0	1	0	1	0	0
other race mexican	n	3	0	0	0	1	2	1	1	0	0
other race mulatto	n	1	0	0	0	1	0	0	0	0	1
other race native hawaiian pacific islander	n	1	1	1	0	0	0	1	0	0	1
other race puerto rican	n	0	0	0	0	0	0	0	0	0	1
other race south east asian	n	0	0	1	0	0	1	0	2	0	1
other race white arabic north african	n	4	2	2	4	2	0	0	0	3	0
other race white european	n	29	20	18	19	20	21	14	19	18	20

Analyses this trial contributes to

Results

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

HbA1c change (27 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	change	-0.17 percent	1.01		50	not stated; modified itt; R0015772:Table 1
16	A1	change	-0.46 percent	0.136		50	not stated; modified itt; registry:outcomes
16	A10	change	-0.87 percent	0.87		33	not stated; modified itt; R0015772:Table 1
16	A10	change	-1.06 percent	0.161		33	not stated; modified itt; registry:outcomes
16	A10 vs A1	md	-0.60 percent		-0.99 to -0.22		not stated; modified itt; R0015772:Results
16	A2	change	-0.54 percent	0.91		34	not stated; modified itt; R0015772:Table 1
16	A3	change	-0.11 percent	1.16		34	not stated; modified itt; R0015772:Table 1
16	A3	change	-0.25 percent	0.159		34	not stated; modified itt; registry:outcomes
16	A3 vs A1	md	0.20 percent		-0.18 to 0.59		not stated; modified itt; registry:outcomes
16	A4	change	-0.49 percent	0.74		34	not stated; modified itt; R0015772:Table 1
16	A4	change	-0.71 percent	0.160		34	not stated; modified itt; registry:outcomes
16	A4 vs A1	md	-0.26 percent		-0.64 to 0.12		not stated; modified itt; registry:outcomes
16	A5	change	-0.87 percent	0.65		29	not stated; modified itt; R0015772:Table 1
16	A5	change	-1.08 percent	0.175		29	not stated; modified itt; registry:outcomes
16	A5 vs A1	md	-0.62 percent		-1.03 to -0.22		not stated; modified itt; R0015772:Results
16	A6	change	-0.56 percent	0.97		30	not stated; modified itt; R0015772:Table 1
16	A6	change	-0.68 percent	0.167		30	not stated; modified itt; registry:outcomes
16	A6 vs A1	md	-0.22 percent		-0.62 to 0.18		not stated; modified itt; registry:outcomes
16	A7	change	-0.79 percent	0.98		32	not stated; modified itt; R0015772:Table 1
16	A7	change	-1.01 percent	0.162		32	not stated; modified itt; registry:outcomes
16	A7 vs A1	md	-0.55 percent		-0.94 to -0.16		not stated; modified itt; registry:outcomes
16	A8	change	-0.79 percent	1.04		34	not stated; modified itt; R0015772:Table 1
16	A8	change	-1.03 percent	0.159		34	not stated; modified itt; registry:outcomes
16	A8 vs A1	md	-0.57 percent		-0.96 to -0.19		not stated; modified itt; R0015772:Results
16	A9	change	-0.55 percent	1.01		35	not stated; modified itt; R0015772:Table 1
16	A9	change	-0.80 percent	0.157		35	not stated; modified itt; registry:outcomes
16	A9 vs A1	md	-0.34 percent		-0.72 to 0.04		not stated; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (10 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
16	A1	change	-0.71 kg	2.883	50	not stated; modified itt; registry:outcomes
16	A10	change	-1.65 kg	3.570	33	not stated; modified itt; registry:outcomes
16	A2	change	-2.41 kg	3.527	34	not stated; modified itt; registry:outcomes
16	A3	change	-0.91 kg	1.733	34	not stated; modified itt; registry:outcomes
16	A4	change	-0.90 kg	2.901	34	not stated; modified itt; registry:outcomes
16	A5	change	-1.43 kg	2.371	29	not stated; modified itt; registry:outcomes
16	A6	change	-1.76 kg	2.828	30	not stated; modified itt; registry:outcomes
16	A7	change	-1.59 kg	2.455	32	not stated; modified itt; registry:outcomes
16	A8	change	-1.14 kg	2.872	34	not stated; modified itt; registry:outcomes
16	A9	change	-1.08 kg	3.177	35	not stated; modified itt; registry:outcomes

HbA1c below 7 percent (5 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
16	A1	responders	20	50	not stated; modified itt; R0015772:Results
16	A10	responders	48	33	not stated; modified itt; R0015772:Results
16	A2	responders	35	34	not stated; modified itt; R0015772:Results
16	A5	responders	52	29	not stated; modified itt; R0015772:Results
16	A8	responders	53	34	not stated; modified itt; R0015772:Results

Percent body weight change (10 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
16	A1	percent change	-0.72 percent	3.403	50	not stated; modified itt; registry:outcomes
16	A10	percent change	-1.89 percent	3.190	33	not stated; modified itt; registry:outcomes
16	A2	percent change	-2.53 percent	4.307	34	not stated; modified itt; registry:outcomes
16	A3	percent change	-0.94 percent	1.838	34	not stated; modified itt; registry:outcomes
16	A4	percent change	-1.04 percent	3.261	34	not stated; modified itt; registry:outcomes
16	A5	percent change	-1.59 percent	2.663	29	not stated; modified itt; registry:outcomes
16	A6	percent change	-1.97 percent	2.908	30	not stated; modified itt; registry:outcomes
16	A7	percent change	-1.69 percent	2.773	32	not stated; modified itt; registry:outcomes
16	A8	percent change	-1.32 percent	3.160	34	not stated; modified itt; registry:outcomes
16	A9	percent change	-1.37 percent	3.571	35	not stated; modified itt; registry:outcomes

Serious adverse events (10 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	2 / 51	while on treatment; safety; registry:adverse_events
A10	events	5 / 34	while on treatment; safety; registry:adverse_events
A2	events	1 / 35	while on treatment; safety; registry:adverse_events
A3	events	0 / 35	while on treatment; safety; registry:adverse_events
A4	events	3 / 35	while on treatment; safety; registry:adverse_events
A5	events	7 / 31	while on treatment; safety; registry:adverse_events
A6	events	2 / 33	while on treatment; safety; registry:adverse_events
A7	events	5 / 32	while on treatment; safety; registry:adverse_events
A8	events	5 / 35	while on treatment; safety; registry:adverse_events
A9	events	7 / 35	while on treatment; safety; registry:adverse_events

Discontinuation due to adverse events (10 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	6 / 52	not stated; randomized; registry:flow
A10	events	9 / 35	not stated; randomized; registry:flow
A2	events	1 / 35	not stated; randomized; registry:flow
A3	events	5 / 36	not stated; randomized; registry:flow
A4	events	6 / 35	not stated; randomized; registry:flow
A5	events	5 / 31	not stated; randomized; registry:flow
A6	events	5 / 34	not stated; randomized; registry:flow
A7	events	5 / 33	not stated; randomized; registry:flow
A8	events	10 / 35	not stated; randomized; registry:flow
A9	events	2 / 35	not stated; randomized; registry:flow

Nausea (10 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	6 / 51	while on treatment; safety; registry:adverse_events
A10	events	18 / 34	while on treatment; safety; registry:adverse_events
A2	events	14 / 35	while on treatment; safety; registry:adverse_events
A3	events	5 / 35	while on treatment; safety; registry:adverse_events
A4	events	7 / 35	while on treatment; safety; registry:adverse_events
A5	events	8 / 31	while on treatment; safety; registry:adverse_events
A6	events	9 / 33	while on treatment; safety; registry:adverse_events
A7	events	8 / 32	while on treatment; safety; registry:adverse_events
A8	events	19 / 35	while on treatment; safety; registry:adverse_events
A9	events	13 / 35	while on treatment; safety; registry:adverse_events

Vomiting (10 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 51	while on treatment; safety; registry:adverse_events
A10	events	14 / 34	while on treatment; safety; registry:adverse_events
A2	events	6 / 35	while on treatment; safety; registry:adverse_events
A3	events	0 / 35	while on treatment; safety; registry:adverse_events
A4	events	3 / 35	while on treatment; safety; registry:adverse_events
A5	events	4 / 31	while on treatment; safety; registry:adverse_events
A6	events	3 / 33	while on treatment; safety; registry:adverse_events
A7	events	3 / 32	while on treatment; safety; registry:adverse_events
A8	events	10 / 35	while on treatment; safety; registry:adverse_events
A9	events	6 / 35	while on treatment; safety; registry:adverse_events

Diarrhea (10 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	2 / 51	while on treatment; safety; registry:adverse_events
A10	events	7 / 34	while on treatment; safety; registry:adverse_events
A2	events	8 / 35	while on treatment; safety; registry:adverse_events
A3	events	5 / 35	while on treatment; safety; registry:adverse_events
A4	events	2 / 35	while on treatment; safety; registry:adverse_events
A5	events	5 / 31	while on treatment; safety; registry:adverse_events
A6	events	4 / 33	while on treatment; safety; registry:adverse_events
A7	events	7 / 32	while on treatment; safety; registry:adverse_events
A8	events	6 / 35	while on treatment; safety; registry:adverse_events
A9	events	6 / 35	while on treatment; safety; registry:adverse_events

Constipation (10 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	while on treatment; safety; registry:adverse_events
A10	events	1 / 34	while on treatment; safety; registry:adverse_events
A2	events	2 / 35	while on treatment; safety; registry:adverse_events
A3	events	1 / 35	while on treatment; safety; registry:adverse_events
A4	events	2 / 35	while on treatment; safety; registry:adverse_events
A5	events	1 / 31	while on treatment; safety; registry:adverse_events
A6	events	0 / 33	while on treatment; safety; registry:adverse_events
A7	events	2 / 32	while on treatment; safety; registry:adverse_events
A8	events	2 / 35	while on treatment; safety; registry:adverse_events
A9	events	1 / 35	while on treatment; safety; registry:adverse_events

Acute pancreatitis (10 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 51	not stated; safety; R0015772:Results
A10	events	0 / 34	not stated; safety; R0015772:Results
A2	events	0 / 35	not stated; safety; R0015772:Results
A3	events	0 / 35	not stated; safety; R0015772:Results
A4	events	0 / 35	not stated; safety; R0015772:Results
A5	events	0 / 31	not stated; safety; R0015772:Results
A6	events	0 / 33	not stated; safety; R0015772:Results
A7	events	0 / 32	not stated; safety; R0015772:Results
A8	events	0 / 35	not stated; safety; R0015772:Results
A9	events	0 / 35	not stated; safety; R0015772:Results