parallel randomized trial

NCT01776788

Effect of Short-Term Intensive Insulin Sequential Exenatide Therapy on β-cell Function and Glycemic Remission Rate in Newly Diagnosed Type 2 Diabetic Patients

Type 2 diabetes (adults)NCT01776788S002224

Design

Randomized: 130
Start year: 2012
Treatment: 12 weeks, follow-up 104.36 weeks
Countries: China (1 sites)
Sponsor: The First Affiliated Hospital of Xiamen University (industry)
Eligibility: age 30 to 70; newly diagnosed drug naive; FPG 7.0 to 16.7 mmol/L; BMI 20 to 35

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Standard care or no added treatment STII only	short term intensive insulin pump therapy about 3 weeks, then diet and exercise; lifestyle: standard	63	63
A2	Exenatide 10 ug subcutaneous twice daily STII plus exenatide	short term intensive insulin pump therapy about 3 weeks, then diet and exercise; lifestyle: standard	67	66

Baseline characteristics

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

Characteristic	Statistic	Standard care or no added treatment A1	Exenatide 10 ug subcutaneous twice daily A2	Whole trial ALL
age	mean (years)			45
age	sd (years)			8
bmi	mean (kg/m2)	24.7	25.2
hba1c	mean (percent)	10.2	9.9
other male	percent	65.1	87.9
sbp	mean (mmHg)	122.9	124.4
waist	mean (cm)	85.8	87.7

Analyses this trial contributes to

Results

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	final	6.49 percent	6.20 to 6.77	37	not stated; other; R0024844:Table 1
12	A2	final	5.83 percent	5.60 to 6.06	60	not stated; other; R0024844:Table 1
52.18	A1	final	6.25 percent	5.90 to 6.59		not stated; other; R0024844:Table 1
52.18	A2	final	6.17 percent	5.92 to 6.41		not stated; other; R0024844:Table 1
104.36	A1	final	6.16 percent	5.50 to 6.82		not stated; other; R0024844:Table 1
104.36	A2	final	6.11 percent	5.66 to 6.57		not stated; other; R0024844:Table 1

Systolic blood pressure change (6 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	final	125.7 mmHg	122.4 to 129.0	37	not stated; other; R0024844:Table 1
12	A2	final	121.9 mmHg	119.3 to 124.6	60	not stated; other; R0024844:Table 1
52.18	A1	final	130.2 mmHg	124.4 to 136.0		not stated; other; R0024844:Table 1
52.18	A2	final	124.7 mmHg	120.8 to 128.6		not stated; other; R0024844:Table 1
104.36	A1	final	128.4 mmHg	121.9 to 135.0		not stated; other; R0024844:Table 1
104.36	A2	final	125.0 mmHg	120.5 to 129.5		not stated; other; R0024844:Table 1

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 63	not stated; randomized; cancer; R0024844:Figure 1
A2	events	1 / 67	not stated; randomized; acute pancreatitis; R0024844:Figure 1
A2	events	2 / 67	not stated; randomized; intolerable gastrointestinal side effects; R0024844:Figure 1

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events	48.4				not stated; other; R0024844:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				2 / 67	not stated; randomized; R0024844:Figure 1

Acute pancreatitis (1 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 67	not stated; randomized; R0024844:Figure 1