parallel randomized trial

NCT01270191

The Effects of Short-Term Exenatide Therapy on the Beta-Cell Function and Long-term Glycemic Control in Newly Diagnosed Type 2 Diabetic Patients

Design

Randomized: 40
Start year: 2010
Treatment: 24 weeks, follow-up 78.21 weeks
Countries: Taiwan
Sponsor: Taipei Veterans General Hospital (non industry)
Eligibility: Newly diagnosed drug naive T2D, age 30 to 70, FPG above 300 mg/dL or HbA1c above 9

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	NPH insulin NPH insulin	none; lifestyle: standard	22	22
A2	Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug twice daily	none; lifestyle: standard	18	17

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

Characteristic	Statistic	NPH insulin A1	Exenatide 10 ug subcutaneous twice daily A2
age	mean (years)	50.3	56.7
age	sd (years)	10.7	11.5
bmi	mean (kg/m2)	27.2	23.1
bmi	sd (kg/m2)	4.0	3.1
female	n	7	12
hba1c	mean (percent)	12.3	12.4
hba1c	sd (percent)	1.80	2.4
sbp	mean (mmHg)	124.3	123.0
sbp	sd (mmHg)	18.6	20.1
uacr	median (mg/g)	14.6	15.0
uacr	q1 (mg/g)	6.8	4.6
uacr	q3 (mg/g)	54.2	37.8
weight	mean (kg)	75.8	60.5
weight	sd (kg)	14.3	12.2

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26.07	A1	final	6.74 percent	1.12		not stated; modified itt; R0012661:Results
26.07	A1	final	6.60 percent	0.97	17	not stated; completers; R0012661:Table 2
26.07	A2	final	6.88 percent	0.76		not stated; modified itt; R0012661:Results
26.07	A2	final	6.88 percent	0.76	16	not stated; completers; R0012661:Table 2
52.14	A1	final	6.62 percent	0.69		not stated; modified itt; R0012661:Results
52.14	A2	final	7.05 percent	0.72		not stated; modified itt; R0012661:Results