parallel randomized trial

Rebuild

Effects on Re-endothelialisation With Bydureon Treatment Add on to Insulin Versus Insulin Alone, Both in Combination With Metformin in Type 2 Diabetic Subjects

Type 2 diabetes (adults)NCT02621489S001903

Design

Randomized: 38
Start year: 2015
Treatment: 12 weeks, follow-up 12 weeks
Countries: Sweden (2 sites)
Sponsor: Karolinska Institutet (mixed)
Eligibility: age 18 to 80; T2D with HbA1c 6.5 to 12.2 percent; eligible for coronary drug eluting stent

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: none, available cases

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release 2 mg subcutaneous once weekly Exenatide once weekly plus standard treatment	metformin and NPH insulin; lifestyle: not reported	20	16
A2	Standard care or no added treatment Standard treatment (metformin and NPH insulin)	metformin and NPH insulin titrated to fasting glucose 6 mmol/L; lifestyle: not reported	18	17

Baseline characteristics

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

Characteristic	Statistic	Exenatide extended release 2 mg subcutaneous once weekly A1	Standard care or no added treatment A2
age	median (years)	66.0	63.0
age	q1 (years)	58.2	55.2
age	q3 (years)	74.7	68.0
bmi	median (kg/m2)	32.0	29.0
bmi	q1 (kg/m2)	30.0	26.4
bmi	q3 (kg/m2)	33.0	31.2
diabetes duration	median (years)	3.0	3.5
diabetes duration	q1 (years)	1.0	0.6
diabetes duration	q3 (years)	8.0	11.5
egfr	mean (mL/min/1.73m2)	80.5	84.2
egfr	sd (mL/min/1.73m2)	14.4	14.6
hba1c	mean (percent)	7.7	7.5
hba1c	sd (percent)	1.7	1.3
insulin use	n	8	7
insulin use	percent	40.0	38.9
lvef	mean (percent)	55.7	54.7
lvef	sd (percent)	6.3	11.0
metformin use	n	19	16
metformin use	percent	95.0	88.9
other male	n	11	11
other male	percent	55.0	61.1
sbp	mean (mmHg)	138.0	125.0
sbp	sd (mmHg)	24.0	18.0
sglt2i use	n	0	1
sglt2i use	percent	0.0	5.6
waist	median (cm)	114.5	108.0
waist	q1 (cm)	107.0	102.0
waist	q3 (cm)	123.0	117.7
weight	mean (kg)	93.5	88.1
weight	sd (kg)	20.8	12.6

Analyses this trial contributes to

Results

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

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-1.1 percent	1		16	not stated; completers; R0014366:Results
12	A2	change	-0.4 percent	1.1		17	not stated; completers; R0014366:Results

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-7.8 kg	19.7		16	not stated; completers; R0014366:Table 4
12	A2	change	0.4 kg	4.1		17	not stated; completers; R0014366:Table 4

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-4.5 mmHg	24.6		16	not stated; completers; R0014366:Table 4
12	A2	change	2.0 mmHg	17.6		17	not stated; completers; R0014366:Table 4

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 20	not stated; safety; R0014366:Results
	A2	events				0 / 18	not stated; safety; R0014366:Results

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 20	not stated; randomized; R0014366:Supplement Table S5
A1	events	1 / 20	not stated; randomized; R0014366:Supplement Table S5
A2	events	1 / 18	not stated; randomized; R0014366:Supplement Table S5

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 20	not stated; randomized; R0014366:Supplement Table S5

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 20	not stated; randomized; R0014366:Supplement Table S5

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 20	not stated; randomized; R0014366:Supplement Table S5
	A1	events				1 / 20	not stated; randomized; R0014366:Supplement Table S5