parallel randomized trial

NCT02229227

Study 200977: Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study

Type 2 diabetes (adults)NCT02229227S001887

Design

Randomized: 814
Start year: 2014
Treatment: 26 weeks, follow-up 30 weeks
Countries
Sponsor: GlaxoSmithKline (industry)
Eligibility: age 18 to 75; HbA1c 7.0 to 9.5 percent at screening; BMI 40 or less; basal plus prandial insulin

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: yes
Primary estimand: not stated
Analysis population: full analysis
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Albiglutide 50 mg subcutaneous once weekly Albiglutide plus glargine	insulin glargine titrated; with or without metformin; lifestyle: not reported	402	402
A2	Insulin lispro (prandial) Lispro + glargine	insulin glargine titrated; metformin in about two thirds; lifestyle: not reported	412	412

Baseline characteristics

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

Characteristic	Statistic	Albiglutide 50 mg subcutaneous once weekly A1	Insulin lispro (prandial) A2
age	mean (years)	58.0	58.1
age	sd (years)	9.4	9.5
black	n	37	32
bmi	mean (kg/m2)	32.1	32.5
bmi	sd (kg/m2)	4.5	4.7
diabetes duration	mean (years)	15.2	14.7
diabetes duration	sd (years)	7.7	7.2
female	n	228	214
female	percent	56.7	51.9
hba1c	mean (percent)	7.7	7.7
hba1c	sd (percent)	0.6	0.6
hispanic	n	159	152
hispanic	percent	39.6	36.9
metformin use	n	269	280
metformin use	percent	66.9	68.0
other race american indian alaska native	n	43	28
other race central south asian	n	5	8
other race japanese east southeast asian	n	25	24
other race multiple	n	7	5
other race native hawaiian pacific islander	n	1	3
weight	mean (kg)	87.8	89.8
weight	sd (kg)	17.3	17.8
white	n	284	312
white	percent	70.6	75.7

Analyses this trial contributes to

Results

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

HbA1c change (5 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.04 percent	0.04		345	not stated; full analysis; R0008089:Table 2
26	A1	change	-1.10 percent	0.8		345	not stated; full analysis; R0008089:Table 2
26	A1 vs A2	md	0.06 percent		-0.05 to 0.17		not stated; full analysis; R0008089:Table 2
26	A2	change	-1.10 percent	0.04		350	not stated; full analysis; R0008089:Table 2
26	A2	change	-1.12 percent	0.8		350	not stated; full analysis; R0008089:Table 2

Body weight change in kilograms (diabetes) (5 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-2.0 kg	0.2		349	not stated; full analysis; R0008089:Table 2
26	A1	change	-2.0 kg	3.6		349	not stated; full analysis; R0008089:Table 2
26	A1 vs A2	md	-4.4 kg		-4.9 to -3.8		not stated; full analysis; R0008089:Table 2
26	A2	change	2.4 kg	0.2		352	not stated; full analysis; R0008089:Table 2
26	A2	change	2.5 kg	4.1		352	not stated; full analysis; R0008089:Table 2

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	60.7		244 / 402	not stated; full analysis; R0008089:Table 2
26	A1 vs A2	or	1.0	0.7 to 1.3		not stated; full analysis; R0008089:Table 2
26	A2	responders	61.9		255 / 412	not stated; full analysis; R0008089:Table 2

Level 2 or 3 hypoglycemia (participants) (9 lines; O04)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			141 / 400	not stated; safety; R0008089:Table 3
A1	events			9 / 400	not stated; safety; R0008089:Table 3
A1	events			290 / 400	not stated; safety; R0008089:Table 3
A1	events			230 / 402	not stated; full analysis; R0008089:Table 3
A1 vs A2	or	0.43	0.31 to 0.60		not stated; full analysis; R0008089:Table 3
A2	events			359 / 413	not stated; safety; R0008089:Table 3
A2	events			309 / 412	not stated; full analysis; R0008089:Table 3
A2	events			239 / 413	not stated; safety; R0008089:Table 3
A2	events			22 / 413	not stated; safety; R0008089:Table 3

Level 2 or 3 hypoglycemia (episode rate) (1 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1 vs A2	rate ratio	0.43		0.36 to 0.52		not stated; safety; R0008089:Table 3

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 400	not stated; safety; acute kidney injury; registry:adverse_events
	A2	events				0 / 413	not stated; safety; acute kidney injury; registry:adverse_events

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 400	not stated; safety; registry:adverse_events
	A2	events				1 / 413	not stated; safety; registry:adverse_events

Health related quality of life total score (any instrument) (5 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	4.3 points	0.6		347	not stated; full analysis; R0008089:Table 2
26	A1	change	4.4 points	12.3		347	not stated; full analysis; R0008089:Table 2
26	A1 vs A2	md	3.2 points		1.7 to 4.8		not stated; full analysis; R0008089:Table 2
26	A2	change	1.1 points	0.6		350	not stated; full analysis; R0008089:Table 2
26	A2	change	0.7 points	11.1		350	not stated; full analysis; R0008089:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				23 / 400	not stated; safety; registry:outcomes
	A2	events				31 / 413	not stated; safety; registry:outcomes

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	12 / 400	not stated; safety; registry:outcomes
A1	events	14 / 400	not stated; safety; R0008089:Results
A2	events	6 / 413	not stated; safety; registry:outcomes
A2	events	9 / 413	not stated; safety; R0008089:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				37 / 400	not stated; safety; registry:adverse_events
	A2	events				7 / 413	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				31 / 400	not stated; safety; registry:adverse_events
	A2	events				18 / 413	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 400	not stated; safety; cholecystitis acute; registry:adverse_events
	A2	events				1 / 413	not stated; safety; cholecystitis acute; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 400	not stated; safety; R0008089:Results
	A2	events				0 / 413	not stated; safety; R0008089:Results

Diabetic retinopathy complications (2 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 400	not stated; safety; diabetic retinopathy; registry:outcomes
	A2	events				17 / 413	not stated; safety; diabetic retinopathy; registry:outcomes

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 400	not stated; safety; registry:outcomes
	A2	events				0 / 413	not stated; safety; registry:outcomes

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 400	not stated; safety; registry:outcomes
	A2	events				2 / 413	not stated; safety; registry:outcomes