The Effect of GLP-1 on Postprandial Glucagon Secretion Independent of The Gastric Emptying Rate (ALFA-1)

Hvidovre University Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Type 1 Diabetes

Treatments: Other: No drug (Baseline day); Procedure: Liquid meal test; Drug: Exenatide; Drug: Liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT02584582

H-3-2014-128

Details and patient eligibility

About

Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1) independent of the gastric emptying rate.

Full description

Aim: To investigate the glucagonostatic effects of glucagon-like peptide-1 (GLP-1) during prolonged and intermittent stimulation of the GLP-1 receptor independent of the gastric emptying rate. Glucagon concentrations will be measured following a liquid meal administered in duodenum at baseline and after exenatide, and liraglutide treatment.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 Diabetes
• >18 years
• No residual beta-cell function (stimulated C-peptide < 60 pmol)

Exclusion criteria

• Pancreatitis
• gastroparesis
• history of alcohol and/or drug abuse
• pregnancy and lactation
• other medical or psychological condition that made the patient unsuitable for study participation according to the investigators´ assessment
• contraindications to gastroscopy
• cancer (unless in complete remission > five years)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Liraglutide + Liquid meal test

Experimental group

Description:

Liraglutide 1.2 mg once daily for 14 days (0.6 mg/day for one week, escalated to 1.2 mg/day after one week)

Treatment:

Procedure: Liquid meal test

Drug: Liraglutide

Exenatide + Liquid meal test

Experimental group

Description:

Exenatide 10 mcg twice daily for 14 days (5 mcg twice daily for one week, escalated to 10 mcg twice daily after one week)

Treatment:

Procedure: Liquid meal test

Drug: Exenatide

Baseline + Liquid meal test

Other group

Description:

Baseline day with no additional medication

Treatment:

Other: No drug (Baseline day)

Procedure: Liquid meal test