parallel randomized trial

NCT00766857

The Effect of Exenatide Compared to Insulin Glargine on Cardiac Function and Metabolism in Type 2 Diabetic Patients With Congestive Heart Failure: a Randomized Comparator-controlled Trial

Type 2 diabetes (adults)NCT00766857S001750

Design

Randomized
Start year: 2009
Treatment: 26 weeks, follow-up 26 weeks
Countries: Netherlands
Sponsor: VU University Medical Center (Eli Lilly support) (industry)
Eligibility: T2D with LVEF below 50; BMI 25 to 40; HbA1c 6.5 to 10.0; metformin with or without SU

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide	metformin or metformin plus sulfonylurea; lifestyle: not reported	14	11
A2	Insulin glargine Insulin glargine	metformin or metformin plus sulfonylurea; lifestyle: not reported		12

Baseline characteristics

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

Characteristic	Statistic	Exenatide 10 ug subcutaneous twice daily A1	Insulin glargine A2	Whole trial ALL
age	mean (years)			66
age	sd (years)			5
bmi	mean (kg/m2)	29.0	29.9
bmi	sd (kg/m2)	2.6	3.3
diabetes duration	median (years)			8
diabetes duration	q1 (years)			5
diabetes duration	q3 (years)			11
egfr	mean (mL/min/1.73 m2)	90	82
egfr	sd (mL/min/1.73 m2)	35	22
established cvd	n			24
established cvd	percent			92
hba1c	mean (percent)	7.7	7.5
hba1c	sd (percent)	1.7	0.8
lvef	mean (percent)	51	50
lvef	sd (percent)	7	9
other male	n			26
other male	percent			100
sbp	mean (mmHg)			127
sbp	sd (mmHg)			17
uacr	median (g/mol)	0.7	1.5
uacr	q1 (g/mol)	0.4	0.7
uacr	q3 (g/mol)	1.3	3.3
waist	mean (cm)	108	109
waist	sd (cm)	9	10

Analyses this trial contributes to

Results

5 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
26	A1	final	7.1 percent	1.9		11	not stated; completers; R0014891:Table 4
26	A2	final	6.8 percent	0.7		12	not stated; completers; R0014891:Table 4

All cause mortality (1 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 14	not stated; randomized; R0014891:Results

Discontinuation due to adverse events (1 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 14	not stated; randomized; R0014891:Results

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 14	not stated; randomized; R0014891:Results