crossover randomized trial

NCT00064714

Effect of AC 2993 (Synthetic Exendin-4) - Administered Alone or in Combination With Daclizumab - on Islet Function in Patients With Type I Diabetes

Design

Randomized: 16
Start year
Treatment: 52.14 weeks
Countries: United States (1 sites)
Sponsor: NIDDK intramural (NIH Clinical Center) (not reported)
Eligibility: Age 18 to 60; T1D at least 5 years; C-peptide at least 0.3 ng/mL; BMI 20 to 30

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	exenatide Exenatide with intensive insulin (on periods)	intensive insulin; daclizumab in half by randomization; lifestyle: not reported		14
A2	Standard care or no added treatment Intensive insulin without exenatide (off periods)	intensive insulin; daclizumab in half by randomization; lifestyle: not reported		14

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

Characteristic	Statistic	Whole trial ALL
age	mean (years)	39.5
age	sd (years)	11.1
bmi	mean (kg/m2)	25.9
bmi	sd (kg/m2)	3.4
diabetes duration	mean (years)	21.3
diabetes duration	sd (years)	10.7
female	n	11
hba1c	mean (percent)	7.3
hba1c	sd (percent)	1.1
other insulin pump	n	13
white	n	20

4 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
26.07	A1	final	6.51 percent	0.56		14	not stated; completers; R0027271:Results
26.07	A2	final	6.64 percent	0.64		14	not stated; completers; R0027271:Results

Total daily insulin dose change (2 lines; O06)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26.07	A1	final	0.48 units/kg/day	0.11		14	not stated; completers; R0027271:Results
26.07	A2	final	0.55 units/kg/day	0.13		14	not stated; completers; R0027271:Results