crossover randomized trial

S003074

Type 2 diabetes (adults)Heart failure with LVEF 40 percent or lowerS003074

Design

Randomized: 20
Start year
Treatment
Countries: Sweden (1 sites)
Sponsor: (mixed)
Eligibility: age 18 to 80; type 2 diabetes; hospitalized heart failure NYHA III to IV; LVEF 35 percent or less

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	exenatide Exenatide intravenous infusion 0.12 pmol/kg/min for 6 h	glucose and insulin infusion to normoglycemia; usual heart failure drugs; lifestyle: not reported	20	20
A2	Placebo Placebo intravenous infusion for 6 h	glucose and insulin infusion to normoglycemia; usual heart failure drugs; lifestyle: not reported	20	20

Baseline characteristics

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

Characteristic	Statistic	Whole trial ALL
age	mean (years)	66
age	se (years)	1
bmi	mean (kg/m2)	31
bmi	se (kg/m2)	1
diabetes duration	mean (years)	13
diabetes duration	se (years)	2
egfr	mean (mL/min/1.73 m2)	64
egfr	se (mL/min/1.73 m2)	7
established cvd: coronary artery disease	percent	60
female	n	0
hba1c	mean (percent)	8.1
hba1c	se (percent)	0.4
insulin use	percent	60
lvef	mean (percent)	26
lvef	se (percent)	2
metformin use	percent	25
other sulfonylurea use	percent	5
other uaer: macroalbuminuria	n	5
other uaer: microalbuminuria	n	7
sbp	mean (mmHg)	140
sbp	se (mmHg)	5

Results

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

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
0.04	A1	final	148 mmHg	6		20	not stated; randomized; R0026992:Table 2
0.04	A2	final	145 mmHg	5		20	not stated; randomized; R0026992:Table 2

Acute kidney injury (1 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 20	not stated; safety; R0026992:Results
	A2	events				0 / 20	not stated; safety; R0026992:Results

Three point MACE (1 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Four point MACE including unstable angina (1 lines; O21B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 20	not stated; safety; R0026992:Results
	A2	events				0 / 20	not stated; safety; R0026992:Results

Heart failure events (1 lines; O23B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

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; R0026992:Results
	A2	events				0 / 20	not stated; safety; R0026992:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 20	not stated; safety; R0026992:Figure 1
	A2	events				0 / 20	not stated; safety; R0026992:Figure 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 20	not stated; safety; nausea/vomiting; R0026992:Results
	A2	events				0 / 20	not stated; safety; R0026992:Results

Vomiting (1 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Constipation (1 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 20	not stated; safety; R0026992:Figure 1
	A2	events				0 / 20	not stated; safety; R0026992:Figure 1

Gallbladder and biliary disease (1 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Acute pancreatitis (1 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Medullary thyroid carcinoma (1 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Thyroid cancer (any) (1 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Diabetic retinopathy complications (1 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Nonarteritic anterior ischemic optic neuropathy (1 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Suicidal ideation or behavior (1 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 20	not stated; safety; R0026992:Results
	A2	events				0 / 20	not stated; safety; R0026992:Results

Gastroparesis (1 lines; O37A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Intestinal obstruction or ileus (1 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Pancreatic cancer (1 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Any cancer (1 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results

Cardiovascular death or heart failure events (1 lines; O40)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 20	not stated; safety; R0026992:Results