parallel randomized trial

NCT01147627

Comparison of Exenatide, Insulin or Pioglitazone on Glycaemic Control and β-cell Function in Drug-naïve Type 2 Diabetic Patients: A Multicentre Randomized Parallel-group Trial

Type 2 diabetes (adults)NCT01147627S000864

Design

Randomized: 416
Start year: 2010
Treatment: 48 weeks, follow-up 48 weeks
Countries: China (25 sites)
Sponsor: Sun Yat-sen University (mixed)
Eligibility: newly diagnosed drug naive T2D; age 30 to 70; HbA1c 7 to 10 percent; BMI 20 to 35

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Exenatide 10 ug subcutaneous twice daily Exenatide	lifestyle: standard	142	110
A2	Premixed insulin Premixed insulin lispro 75/25	lifestyle: standard	138	114
A3	Pioglitazone Pioglitazone	lifestyle: standard	136	118

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	Premixed insulin A2	Pioglitazone A3
age: 18 to 65	n	132	128	129
age: 65 or more	n	10	10	7
age	mean (years)	49.89	51.39	49.66
age	sd (years)	9.64	9.65	8.86
bmi	mean (kg/m2)	25.9	25.6	25.9
bmi	sd (kg/m2)	0.4	0.4	0.3
female	n	44	53	53
hba1c	mean (percent)	8.2	8.1	8.0
hba1c	sd (percent)	0.1	0.1	0.1

Analyses this trial contributes to

Results

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

HbA1c change (9 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
48	A1	change	-1.9 percent	0.2	88	not stated; completers; R0021706:Table 1
48	A1	change	-1.8 percent	1.29	110	not stated; other; registry:outcomes
48	A1	final	6.2 percent	0.1	88	not stated; completers; R0021706:Table 1
48	A2	change	-1.6 percent	0.3	84	not stated; completers; R0021706:Table 1
48	A2	change	-1.74 percent	1.16	114	not stated; other; registry:outcomes
48	A2	final	6.5 percent	0.1	84	not stated; completers; R0021706:Table 1
48	A3	change	-1.6 percent	0.2	109	not stated; completers; R0021706:Table 1
48	A3	change	-1.47 percent	1.30	118	not stated; other; registry:outcomes
48	A3	final	6.6 percent	0.1	109	not stated; completers; R0021706:Table 1

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
48	A1	change	-3.8 kg	0.4	88	not stated; completers; R0021706:Table 1
48	A2	change	-0.1 kg	0.8	84	not stated; completers; R0021706:Table 1
48	A3	change	0.1 kg	0.4	109	not stated; completers; R0021706:Table 1

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
48	A1	change	-2.4 mmHg	2.3	88	not stated; completers; R0021706:Table 1
48	A2	change	-1.6 mmHg	2.3	84	not stated; completers; R0021706:Table 1
48	A3	change	-1 mmHg	1	109	not stated; completers; R0021706:Table 1

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	5 / 142	not stated; randomized; registry:adverse_events
A2	events	1 / 138	not stated; randomized; registry:adverse_events
A3	events	7 / 136	not stated; randomized; registry:adverse_events

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	37 / 142	not stated; randomized; registry:adverse_events
A2	events	1 / 138	not stated; randomized; registry:adverse_events
A3	events	1 / 136	not stated; randomized; registry:adverse_events

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	15 / 142	not stated; randomized; registry:adverse_events
A2	events	1 / 138	not stated; randomized; registry:adverse_events
A3	events	1 / 136	not stated; randomized; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	6 / 142	not stated; randomized; registry:adverse_events
A2	events	1 / 138	not stated; randomized; registry:adverse_events
A3	events	4 / 136	not stated; randomized; registry:adverse_events

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	6 / 142	not stated; randomized; registry:adverse_events
A2	events	0 / 138	not stated; randomized; registry:adverse_events
A3	events	1 / 136	not stated; randomized; registry:adverse_events

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	1 / 142	not stated; randomized; registry:adverse_events
A2	events	0 / 138	not stated; randomized; registry:adverse_events
A3	events	0 / 136	not stated; randomized; registry:adverse_events