parallel randomized trial

NCT00082381

Effect of AC2993 (Synthetic Exendin-4) Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

Type 2 diabetes (adults)NCT00082381S000965

Design

Randomized: 551
Start year: 2003
Treatment: 26 weeks, follow-up 26 weeks
Countries: Australia, Belgium, Brazil, Finland, Germany, Norway, Poland, Portugal, Puerto Rico, Spain, Sweden, Netherlands, United States (82 sites)
Sponsor: AstraZeneca (industry)
Eligibility: age 30 to 75; HbA1c 7.0 to 10.0 percent; BMI 25 to 45 kg/m2; on metformin and sulfonylurea

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug BID	metformin and sulfonylurea; lifestyle: not reported	283	282
A2	Insulin glargine Insulin glargine titrated	metformin and sulfonylurea; lifestyle: not reported	268	267

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	Insulin glargine A2
age	mean (years)	59.80	57.96
age	sd (years)	8.82	9.46
black	n	1	3
black	percent	0.4	1.3
bmi	mean (kg/m2)	31.6	31.4
bmi	sd (kg/m2)	4.5	4.5
diabetes duration	mean (years)	9.7	9.2
diabetes duration	sd (years)	5.6	5.9
female	n	127	116
hba1c	mean (percent)	8.13	8.19
hba1c	se (percent)	0.07	0.07
hispanic	n	37	35
hispanic	percent	16.2	15.4
other race american indian alaska native	n	0	1
other race american indian alaska native	percent	0.0	0.4
other race other	n	4	5
other race other	percent	1.8	2.2
other race west asian	n	5	2
other race west asian	percent	2.2	0.9
weight	mean (kg)	88.42	89.25
weight	se (kg)	1.16	1.20
white	n	181	181
white	percent	79.4	79.7

Results

41 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	95% CI	Events / N	Detail
26	A1 vs A2	md	0.05 percent		-0.09 to 0.20		not stated; modified itt; registry:outcomes
26	A1	change	-0.72 percent	0.12			not stated; modified itt; region:poland; R0026391:Results
26	A1	change	-1.00 percent	0.06		275	not stated; modified itt; registry:outcomes
26	A1 vs A2	md	-0.07 percent	0.17	-0.41 to 0.26		not stated; modified itt; region:poland; R0026391:Results
26	A2	change	-1.05 percent	0.06		260	not stated; modified itt; registry:outcomes
26	A2	change	-0.64 percent	0.12			not stated; modified itt; region:poland; R0026391:Results

Body weight change in kilograms (diabetes) (5 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.9 kg	0.48			not stated; modified itt; region:poland; R0026391:Results
26	A1	change	-2.32 kg	0.21		231	not stated; modified itt; registry:outcomes
26	A1 vs A2	md	-3.5 kg	0.68	-4.9 to -2.2		not stated; modified itt; region:poland; R0026391:Results
26	A2	change	1.75 kg	0.21		244	not stated; modified itt; registry:outcomes
26	A2	change	1.6 kg	0.48			not stated; modified itt; region:poland; R0026391:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders	46.43			282	not stated; modified itt; registry:outcomes
26	A2	responders	48.03			267	not stated; modified itt; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	55.32	282	not stated; modified itt; registry:outcomes
A1	events		156 / 282	not stated; safety; registry:adverse_events
A2	events	59.93	267	not stated; modified itt; registry:outcomes
A2	events		160 / 267	not stated; safety; registry:adverse_events

Health related quality of life total score (any instrument) (8 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	final	0.85 points	0.19		not stated; per protocol; R0027756:Table 2
26	A1	change	3.42 points	0.43	213	not stated; per protocol; R0027756:Table 3
26	A1	change	0.02 points	0.01	217	not stated; per protocol; R0027756:Table 3
26	A1	final	29.48 points	6.12		not stated; per protocol; R0027756:Table 2
26	A2	change	3.85 points	0.43	213	not stated; per protocol; R0027756:Table 3
26	A2	change	0.03 points	0.01	215	not stated; per protocol; R0027756:Table 3
26	A2	final	30.04 points	5.21		not stated; per protocol; R0027756:Table 2
26	A2	final	0.87 points	0.20		not stated; per protocol; R0027756:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 282	not stated; safety; registry:adverse_events
	A2	events				10 / 267	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				27 / 283	not stated; randomized; registry:flow
	A2	events				2 / 268	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				161 / 282	not stated; safety; registry:adverse_events
	A2	events				23 / 267	not stated; safety; registry:adverse_events

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	49 / 282	not stated; safety; registry:adverse_events
A1	events	1 / 282	not stated; safety; registry:adverse_events
A2	events	10 / 267	not stated; safety; registry:adverse_events
A2	events	0 / 267	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				24 / 282	not stated; safety; registry:adverse_events
	A2	events				8 / 267	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 282	not stated; safety; cholelithiasis; registry:adverse_events
	A2	events				0 / 267	not stated; safety; cholelithiasis; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 282	not stated; safety; registry:adverse_events
	A2	events				1 / 267	not stated; safety; registry:adverse_events