parallel randomized trial

SIMPLE

The Effect of Simple Insulin Detemir Titration, Metformin Plus Liraglutide Compared to Simple Insulin Detemir Titration Plus Insulin Aspart and Metformin for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study: A 26 Week, Randomized, Open Label, Parallel-group, Intention to Treat Study

Type 2 diabetes (adults)NCT01966978S002252

Design

Randomized: 120
Start year: 2014
Treatment: 26 weeks, follow-up 26 weeks
Countries: United States
Sponsor: University of Texas Southwestern Medical Center (industry)
Eligibility: age 18 or older; HbA1c 10 or higher; no prandial insulin, DPP-4 inhibitor or GLP-1 RA

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Insulin aspart (prandial) Basal bolus insulin (detemir plus aspart) with metformin	insulin detemir self titrated to fasting 71 to 100 mg/dL; metformin to maximum tolerated; lifestyle: not reported	61	44
A2	Liraglutide subcutaneous once daily, flexible dose: 1.2 or 1.8 mg by tolerability Liraglutide plus insulin detemir with metformin	insulin detemir self titrated to fasting 71 to 100 mg/dL; metformin to maximum tolerated; lifestyle: not reported	59	46

Baseline characteristics

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

Characteristic	Statistic	Insulin aspart (prandial) A1	Liraglutide subcutaneous once daily, flexible dose: 1.2 or 1.8 mg by tolerability A2	Whole trial ALL
age	mean (years)	48.1	46.7
age	sd (years)	10.0	9.0
black	n	30	20
diabetes duration	mean (years)			10
female	n	45	40
hba1c	mean (percent)	12.0	12.1
hba1c	sd (percent)	1.5	1.4
hispanic	n	21	27
insulin use	percent			76
white	n	10	12

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	change	3.4 percent	2.4 to 3.7	44	not stated; completers; registry:outcomes
26	A2	change	4.1 percent	3.5 to 4.8	46	not stated; completers; registry:outcomes
26	A2 vs A1	md	-0.91 percent	-1.86 to 0.03		not stated; modified itt; R0019591:Results

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	change	3.1 kg	1.7 to 4.6	44	not stated; completers; registry:outcomes
26	A2	change	-0.6 kg	-0.9 to 2.1	46	not stated; completers; registry:outcomes
26	A2 vs A1	md	-3.8 kg	-6.0 to -1.6		not stated; modified itt; R0019591:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders	20			44	not stated; completers; registry:outcomes
26	A2	responders	44			46	not stated; completers; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	66.1			44	not stated; completers; registry:outcomes
	A2	events	35.2			46	not stated; completers; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 56	not stated; safety; registry:adverse_events
	A2	events				0 / 54	not stated; safety; registry:adverse_events

SF-36 physical component summary change (2 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-0.1 points		-0.4 to 0.2	44	not stated; completers; registry:outcomes
26	A2	change	0.007 points		-0.3 to 0.3	46	not stated; completers; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				13 / 56	not stated; safety; registry:adverse_events
	A2	events				6 / 54	not stated; safety; registry:adverse_events

Diabetic retinopathy complications (2 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 56	not stated; safety; vitreal hemmorhage; registry:adverse_events
	A2	events				1 / 54	not stated; safety; vitreal hemmorhage; registry:adverse_events

Intestinal obstruction or ileus (2 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 56	not stated; safety; small bowel obstruction; registry:adverse_events
	A2	events				0 / 54	not stated; safety; small bowel obstruction; registry:adverse_events