parallel randomized trial

NCT00894322

A Two-Cohort, Single- and Repeat Dose Study to Examine the Pharmacokinetics, Tolerability, and Safety of Ready to Use Exenatide Once Weekly in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT00894322S001058

Design

Randomized: 35
Start year: 2009
Treatment: 12 weeks
Countries: United States
Sponsor: AstraZeneca (industry)
Eligibility: adults with T2D on diet and exercise, metformin, TZD or both

Conduct and analysis

Blinding: single blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release 2 mg subcutaneous once weekly Exenatide once weekly suspension 2 mg	diet and exercise, metformin, TZD or both; lifestyle: not reported	23	23
A2	Placebo Placebo	diet and exercise, metformin, TZD or both; lifestyle: not reported	12	12

Baseline characteristics

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

Characteristic	Statistic	Exenatide extended release 2 mg subcutaneous once weekly A1	Placebo A2
age	mean (years)	52.7	52.0
age	sd (years)	11.6	9.3
asian	n	0	1
black	n	1	0
bmi	mean (kg/m2)	35.3	34.9
bmi	sd (kg/m2)	6.7	4.9
female	n	9	2
hispanic	n	2	0
other native american	n	1	0
weight	mean (kg)	104.9	104.4
weight	sd (kg)	23.2	20.3
white	n	19	11

Analyses this trial contributes to

Results

24 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
12	A1	change	-0.87 percent	0.179		23	not stated; modified itt; registry:outcomes
12	A1 vs A2	md	-0.95 percent		-1.50 to -0.40		not stated; modified itt; registry:outcomes
12	A2	change	0.08 percent	0.231		12	not stated; modified itt; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-1.41 kg	0.558		23	not stated; modified itt; registry:outcomes
12	A1 vs A2	md	-1.03 kg		-2.73 to 0.68		not stated; modified itt; registry:outcomes
12	A2	change	-0.39 kg	0.717		12	not stated; modified itt; registry:outcomes

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	responders				14 / 23	not stated; modified itt; registry:outcomes
12	A2	responders				2 / 12	not stated; modified itt; registry:outcomes

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-8.4 mmHg	14.15		23	not stated; modified itt; registry:outcomes
12	A2	change	-1.7 mmHg	12.47		12	not stated; modified itt; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 23	not stated; modified itt; registry:outcomes
	A2	events				0 / 12	not stated; modified itt; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 23	not stated; modified itt; registry:outcomes
	A2	events				1 / 12	not stated; modified itt; registry:outcomes

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 23	not stated; modified itt; registry:outcomes
	A2	events				0 / 12	not stated; modified itt; registry:outcomes

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 23	not stated; safety; registry:adverse_events
	A2	events				1 / 12	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 23	not stated; safety; registry:adverse_events
	A2	events				1 / 12	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 23	not stated; safety; registry:adverse_events
	A2	events				2 / 12	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 23	not stated; safety; registry:adverse_events
	A2	events				0 / 12	not stated; safety; registry:adverse_events