parallel randomized trial

NCT01784965

Addition of a Glucagon-like Peptide-1 to a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and Cardiovascular Disease.

Overweight or obesity without diabetes (adults)NCT01784965S000139

Design

Randomized: 68
Start year: 2009
Treatment: 14 weeks, follow-up 14 weeks
Countries: United States (1 sites)
Sponsor: Stanford University (mixed)
Eligibility: age 40 to 70; BMI 27 to 40; prediabetes by fasting or 2 h glucose; no T2D

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	500 kcal deficit diet with dietitian visits; lifestyle: intensive	35	24
A2	Placebo Placebo	500 kcal deficit diet with dietitian visits; lifestyle: intensive	33	27

Baseline characteristics

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

Characteristic	Statistic	Liraglutide 1.8 mg subcutaneous once daily A1	Placebo A2
age	mean (years)	58	58
age	sd (years)	7	8
bmi	mean (kg/m2)	31.9	31.9
bmi	sd (kg/m2)	2.7	3.5
female	n	16	17

Analyses this trial contributes to

Results

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

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
14	A1	change	-8.1 mmHg			24	not stated; completers; R0026736:Abstract
14	A2	change	-2.6 mmHg			27	not stated; completers; R0026736:Abstract

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
14	A1	responders	88			24	not stated; completers; R0026736:Results
14	A2	responders	22			27	not stated; completers; R0026736:Results

Weight loss of 10 percent or more (2 lines; O11B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
14	A1	responders	17			24	not stated; completers; R0026736:Results
14	A2	responders				0 / 27	not stated; completers; R0026736:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 35	not stated; randomized; registry:adverse_events
	A2	events				0 / 33	not stated; randomized; 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				8 / 35	not stated; randomized; R0026736:Results
	A2	events				0 / 33	not stated; randomized; R0026736:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	67			24	not stated; completers; R0026736:Results
	A2	events	26			27	not stated; completers; R0026736:Results

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 35	not stated; randomized; R0026736:Results
	A2	events				0 / 33	not stated; randomized; R0026736:Results

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 35	not stated; randomized; Gallstones; registry:adverse_events
	A2	events				0 / 33	not stated; randomized; Gallstones; registry:adverse_events