crossover randomized trial

COCOA

A Comparison of the Haemodynamic and Metabolic Effects of Intravenous Glucagon-like Peptide-1, Glucagon and Glucagon-like Peptide-1:Glucagon Co-agonism in Healthy Male Participants

Other conditions NCT03835013S001753

Design

Randomized
Start year: 2019
Treatment: 0.14 weeks, follow-up 15 weeks
Countries: United Kingdom (1 sites)
Sponsor: Cambridge University Hospitals NHS Foundation Trust (mixed)
Eligibility: healthy nonsmoking men aged 18 to 40 years, BMI 18 to 30 kg/m2

Conduct and analysis

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

Arms

Arm	Treatment	Background	Analyzed
A1	Placebo Part B saline	lifestyle: none	12
A2	exenatide Part B exenatide infusion	lifestyle: none	12
A3	Glucagon Part B glucagon infusion	lifestyle: none	12
A4	exenatide plus glucagon Part B exenatide plus glucagon co-infusion	lifestyle: none	12

Baseline characteristics

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

Characteristic	Statistic	Whole trial ALL
age	max (years)	33
age	median (years)	24
age	min (years)	20
age	q1 (years)	22
age	q3 (years)	26
bmi	median (kg/m2)	22
bmi	q1 (kg/m2)	20
bmi	q3 (kg/m2)	27
hba1c	median (mmol/mol)	33
hba1c	q1 (mmol/mol)	31
hba1c	q3 (mmol/mol)	34
sbp	median (mmHg)	118
sbp	q1 (mmHg)	113
sbp	q3 (mmHg)	125
weight	median (kg)	77
weight	q1 (kg)	59
weight	q3 (kg)	88

Results

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

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 12	not stated; completers; R0017551:Results
A2	events	0 / 12	not stated; completers; R0017551:Results
A3	events	0 / 12	not stated; completers; R0017551:Results
A4	events	0 / 12	not stated; completers; R0017551:Results