parallel randomized trial

NCT00434954

Effect of Exenatide Plus Metformin vs. Premixed Human Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Inadequate Control of Type 2 Diabetes on Oral Antidiabetic Treatment

Type 2 diabetes (adults)NCT00434954S000790

Design

Randomized: 494
Start year: 2007
Treatment: 26 weeks
Countries: Germany (68 sites)
Sponsor: AstraZeneca (industry)
Eligibility: adults with T2D on metformin, HbA1c 6.5 to 10.0 percent

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug twice daily	metformin unchanged; lifestyle: not reported	248	181
A2	Premixed insulin Premixed insulin aspart 70/30 twice daily	metformin unchanged; lifestyle: not reported	246	173

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
age	mean (years)	57.2	56.9
age	sd (years)	10.03	9.94
bmi	mean (kg/m2)	33.4	32.9
bmi	sd (kg/m2)	4.23	4.37
diabetes duration	mean (years)	4.8	5.2
diabetes duration	sd (years)	4.39	4.67
female	n	73	77
hba1c	mean (percent)	7.89	7.88
hba1c	sd (percent)	0.822	0.918
weight	mean (kg)	99.4	96.6
weight	sd (kg)	16.22	17.40

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.00 percent	0.05		181	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	0.14 percent		-0.003 to 0.291		not stated; full analysis; R0027127:Results
26	A2	change	-1.14 percent	0.05		173	not stated; full analysis; registry:outcomes

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-4.10 kg	0.22		181	not stated; full analysis; registry:outcomes
26	A2	change	1.02 kg	0.22		173	not stated; full analysis; registry:outcomes

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders	49.2			181	not stated; full analysis; R0027127:Results
26	A2	responders	56.6			173	not stated; full analysis; R0027127:Results

Level 2 or 3 hypoglycemia (participants) (2 lines; O04)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	1.8			181	not stated; full analysis; R0027127:Results
	A2	events	6.3			173	not stated; full analysis; R0027127:Results

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 247	not stated; full analysis; renal failure acute; registry:adverse_events
	A2	events				1 / 233	not stated; full analysis; renal failure acute; registry:adverse_events

SF-36 physical component summary change (2 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	final	39.1 points	14.30		181	not stated; full analysis; registry:outcomes
26	A2	final	37.7 points	14.28		173	not stated; full analysis; registry:outcomes

Health related quality of life total score (any instrument) (2 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	final	30.6 points	6.05		181	not stated; full analysis; registry:outcomes
26	A2	final	29.3 points	6.59		173	not stated; full analysis; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 247	not stated; full analysis; registry:adverse_events
	A2	events				8 / 233	not stated; full analysis; registry:adverse_events

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	7.2	181	not stated; full analysis; R0027127:Results
A1	events		17 / 248	not stated; randomized; registry:flow
A2	events	0.6	173	not stated; full analysis; R0027127:Results
A2	events		2 / 246	not stated; randomized; registry:flow

Nausea (3 lines; O27A)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	18.8	181	not stated; full analysis; R0027127:Results
A1	events		46 / 247	not stated; full analysis; registry:adverse_events
A2	events		8 / 233	not stated; full analysis; registry:adverse_events

Vomiting (3 lines; O27B)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	9.9	181	not stated; full analysis; R0027127:Results
A1	events		22 / 247	not stated; full analysis; registry:adverse_events
A2	events		2 / 233	not stated; full analysis; registry:adverse_events

Diarrhea (4 lines; O27C)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	10.5	181	not stated; full analysis; R0027127:Results
A1	events		27 / 247	not stated; full analysis; registry:adverse_events
A2	events	8.1	173	not stated; full analysis; R0027127:Results
A2	events		16 / 233	not stated; full analysis; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 247	not stated; full analysis; cholecystitis acute; registry:adverse_events
	A2	events				1 / 233	not stated; full analysis; cholecystitis acute; registry:adverse_events