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

Type 1 Diabetes Clinical Trial

— ALFA-1  

Official title:

The Effect of GLP-1 on Postprandial Glucagon Secretion During Prolonged and Intermittent Stimulation of the GLP-1 Receptor Independent of The Gastric Emptying Rate. A Randomized, Open-label Study in People With Type 1 Diabetes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02584582
• Other study ID #: H-3-2014-128
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: August 6, 2015
• Last updated: October 21, 2015
• Start date: July 2015

Study information

• Verified date: October 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Liraglutide

• Exenatide

Procedure:
• Liquid meal test

Other:
• No drug (Baseline day)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucagon concentration (postprandial)	glucagon area under the curve (AUC) (0-240 minutes) and baseline to peak increments will be calculated	4 hours	No
Secondary	Postprandial glucose concentrations	glucose AUC (0-240 minutes) and baseline to peak increments will be calculated	4 hours	No
Secondary	glucagon-like peptide-1 (GLP-1)	GLP-1 AUC (0-240 minutes) and baseline to peak increments will be calculated	4 hours	No
Secondary	glucagon-like peptide-2 (GLP-2)	GLP-2 AUC (0-240 minutes) and baseline to peak increments will be calculated	4 hours	No
Secondary	glucose-dependent insulinotropic polypeptide (GIP)	GIP AUC (0-240 minutes) and baseline to peak increments will be calculated	4 hours	No
Secondary	Cholecystokinin (CCK)	CCKAUC (0-240 minutes) and baseline to peak increments will be calculated	4 hours	No
Secondary	Peptide YY (PYY)	PYY AUC (0-240 minutes) and baseline to peak increments will be calculated	4 hours	No
Secondary	Ghrelin	Ghrelin AUC (0-240 minutes) and baseline to peak increments will be calculated	4 hours	No
Secondary	Gastrin	Gastrin AUC (0-240 minutes) and baseline to peak increments will be calculated	4 hours	No
Secondary	Oxyntomodulin	Oxyntomodulin AUC (0-240 minutes) and baseline to peak increments will be calculated	4 hours	No
Secondary	Free fatty acids (FFA)	FFA AUC (0-240 minutes) and baseline to peak increments will be calculated	4 hours	No
Secondary	triacylglycerol (TAG)	TAG AUC (0-240 minutes) and baseline to peak increments will be calculated	4 hours	No