parallel randomized trial

NCT00097500

A Phase 3, Randomized, Open Label, Comparator-Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects With Type 2 Diabetes Treated With Metformin Who Have Not Achieved Target HbA1c

Type 2 diabetes (adults)NCT00097500S001020

Design

Randomized: 69
Start year: 2004
Treatment: 52 weeks, follow-up 64 weeks
Countries: Finland, Netherlands, Sweden (3 sites)
Sponsor: Amylin Pharmaceuticals; Eli Lilly and Company (industry)
Eligibility: age 30 to 75; HbA1c 6.5 to 9.5 percent; BMI 25 to 40; on metformin

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	exenatide Exenatide	metformin; lifestyle: not reported	36	30	30
A2	Insulin glargine Insulin glargine	metformin; lifestyle: not reported	33	30	30

Baseline characteristics

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

Characteristic	Statistic	Exenatide A1	Insulin glargine A2
age	mean (years)	58.4	58.3
age	sd (years)	8.4	7.3
age	se (years)	1.4	1.3
bmi	mean (kg/m2)	30.9	30.1
bmi	sd (kg/m2)	4.15	3.49
bmi	se (kg/m2)	0.7	0.6
diabetes duration	mean (years)	5.7	4.0
diabetes duration	sd (years)	4.70	3.62
diabetes duration	se (years)	0.8	0.6
female	n	13	11
hba1c	mean (percent)	7.6	7.4
hba1c	sd (percent)	0.89	0.81
hba1c	se (percent)	0.1	0.1
waist	mean (cm)	106.1	106.9
waist	se (cm)	1.9	1.9
weight	mean (kg)	90.6	92.4
weight	sd (kg)	12.66	13.56
weight	se (kg)	2.1	2.4

Analyses this trial contributes to

Results

53 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
52	A1	change	-0.97 percent	0.14	36	not stated; randomized; registry:outcomes
52	A1	change	-0.8 percent	0.1		not stated; other; R0027264:Results
52	A2	change	-0.7 percent	0.2		not stated; other; R0027264:Results
52	A2	change	-0.87 percent	0.15	33	not stated; randomized; registry:outcomes
168	A1	final	6.6 percent	0.2		not stated; other; R0027787:Results
168	A2	final	6.9 percent	0.2		not stated; other; R0027787:Results

Body weight change in kilograms (diabetes) (12 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
52	A1	change	-3.80 kg	0.87	36	not stated; randomized; registry:outcomes
52	A1	change	-3.6 kg	0.6		not stated; other; R0027264:Results
52	A1	final	86.4 kg	2.6	30	not stated; other; R0027078:Table 1
52	A1 vs A2	md	-4.6 kg	1.1		not stated; other; R0027264:Results
52	A2	change	1.0 kg	0.8		not stated; other; R0027264:Results
52	A2	change	0.75 kg	0.95	33	not stated; randomized; registry:outcomes
52	A2	final	93.8 kg	2.7	29	not stated; other; R0027078:Table 1
64	A1 vs A2	md	-2.4 kg	1.1		not stated; other; R0027264:Results
168	A1 vs A2	md	-7.9 kg	1.8		not stated; other; R0027787:Results
168	A1	change	-5.7 kg	1.3		not stated; other; R0027787:Results
168	A2	change	2.1 kg	1.3		not stated; other; R0027787:Results
180	A1 vs A2	md	-5.5 kg	1.7		not stated; other; R0027787:Results

Level 2 or 3 hypoglycemia (participants) (10 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	19	21	not stated; other; R0027787:Results
A1	events		6 / 36	not stated; safety; registry:adverse_events
A1	events		0 /	not stated; other; R0027264:Results
A1	events	8.3	36	not stated; other; R0027264:Results
A1	events		0 /	not stated; other; R0027787:Results
A2	events	24.2	33	not stated; other; R0027264:Results
A2	events	28	25	not stated; other; R0027787:Results
A2	events		0 /	not stated; other; R0027787:Results
A2	events		0 /	not stated; other; R0027264:Results
A2	events		10 / 33	not stated; safety; registry:adverse_events

Percent body weight change (3 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
52	A1 vs A2	md	-5 percent	-7 to -2		not stated; other; R0027078:Table 1
52	A1	percent change	-6 percent	-8 to -3	30	not stated; other; R0027078:Table 1
52	A2	percent change	-1 percent	-3 to 1	29	not stated; other; R0027078:Table 1

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 36	not stated; safety; registry:adverse_events
	A2	events				1 / 33	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (5 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	5 / 36	not stated; randomized; R0027078:Supplemental Figure 1
A1	events	2 / 21	not stated; other; nausea or vomiting; R0027787:Results
A1	events	5 / 36	not stated; randomized; registry:flow
A2	events	0 / 33	not stated; randomized; registry:flow
A2	events	1 / 25	not stated; other; cerebrovascular incident; R0027787:Results

Nausea (4 lines; O27A)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		18 / 36	not stated; safety; registry:adverse_events
A1	events	38.1	21	not stated; other; R0027787:Results
A1	events	50	36	not stated; other; R0027264:Results
A2	events		0 / 33	not stated; safety; registry:adverse_events

Vomiting (4 lines; O27B)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	9.5	21	not stated; other; R0027787:Results
A1	events		4 / 36	not stated; safety; registry:adverse_events
A2	events	8.0	25	not stated; other; R0027787:Results
A2	events		0 / 33	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		3 / 36	not stated; safety; registry:adverse_events
A1	events	4.8	21	not stated; other; R0027787:Results
A2	events		1 / 33	not stated; safety; registry:adverse_events

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 21	not stated; other; nausea or vomiting; R0027787:Results

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	1 / 36	not stated; other; pancreatitis; R0027264:Results
A1	events	1 / 36	not stated; safety; pancreatitis; registry:adverse_events
A2	events	0 / 33	not stated; safety; pancreatitis; registry:adverse_events