parallel randomized trial

NCT01406262

A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin)

Other conditions NCT01406262S002100

Design

Randomized: 174
Start year: 2011
Treatment: 6 weeks
Countries: (1 sites)
Sponsor: GlaxoSmithKline (industry)
Eligibility: healthy nonsmoking adults 18 to 45 years; QTc below 450 ms

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: other
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Albiglutide 50 mg subcutaneous once weekly Albiglutide	lifestyle: not reported	85	85
A2	Placebo Albiglutide placebo with moxifloxacin nested crossover	lifestyle: not reported	89	88

Baseline characteristics

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

Characteristic	Statistic	Albiglutide 50 mg subcutaneous once weekly A1	Placebo A2	Whole trial ALL
age	max (years)			45
age	mean (years)			29.5
age	min (years)			18
bmi	max (kg/m2)			30.0
bmi	mean (kg/m2)			25.2
bmi	min (kg/m2)			19.3
other male	percent	67	50
white	percent	61.2	70.5

Results

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

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 85	not stated; safety; R0016123:Results
	A2	events				1 / 89	not stated; safety; R0016123:Results

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 85	not stated; safety; R0016123:Results
A1	events	1 / 85	not stated; randomized; R0016123:Figure 1
A2	events	3 / 89	not stated; safety; R0016123:Results
A2	events	3 / 89	not stated; randomized; R0016123:Figure 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	8.2			85	not stated; safety; R0016123:Results
	A2	events	11.4			89	not stated; safety; R0016123:Results

Vomiting (1 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	8.2			85	not stated; safety; R0016123:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 89	not stated; safety; vomiting; R0016123:Results