Trial intelligence / Profile preview

Glucagon Cardiovascular Effects with Beta-blocker Inhibition

NCT03533179Phase 4

Key facts

Status: Completed
Start: Jun 2018
Primary completion: Oct 2019
Countries: 1
Sponsor: Bispebjerg and Frederiksberg Hospital
Modality: Peptides, Recombinant Proteins and Enzymes

Drugs: glucagon

Overview

Phase 4, randomised, double-blind trial of glucagon (5 arms), sponsored by Bispebjerg and Frederiksberg Hospital. Primary endpoint: Heart rates on the esmolol+glucagon-day compared to the esmolol+placebo-day. Started Jun 2018; status: completed.

Design

5 arms

Study design: RandomizedDouble-blind

Placebo/Placebo
Saline infusion (Esmolol dummy) + Saline bolus (Glucagon dummy)
Esmolol/Placebo
Esmolol infusion + Saline bolus (Glucagon dummy)
Esmolol/Glucagon Bolus
Esmolol infusion + Glucagon bolus (50 mcg/kg)
Placebo/Glucagon Infusion
Saline infusion (Esmolol dummy) + Glucagon infusion (50 mcg/kg over 30 min)
Placebo/Glucagon Bolus
Saline infusion (Esmolol dummy) + Glucagon bolus (50 mcg/kg)

Who it enrols

Healthy males aged 18+ with BMI 18.5-29.9 and weight 50-100 kg. Excludes bradycardia (<45 bpm), hypotension (SBP <100 mmHg), heart disease, diabetes, and other significant medical conditions.

Endpoints

Primary

Heart rates on the esmolol+glucagon-day compared to the esmolol+placebo-dayGlucagon bolus + 5 minutes

Secondary

Change in heart rate from baseline compared between study days60 min
Change in stroke volume from baseline compared between study days60 min
Change in systolic, diastolic and mean arterial pressure from baseline compared between study days60 min
Glucagon pharmacokinetics60 min
Effects of glucagon on blood glucose compared to placebo60 min
Adverse effects of glucagon60 min

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