GIP Receptor Antagonist Studies in Humans

Not Applicable

Completed

• Conditions: Glucose Metabolism
• Interventions: Drug: GIP-A; Other: Saline; Drug: GIP(1-42)

• Registration Number: NCT02747472
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of insulin secretion.

Detailed Description

Aim: To evaluate the GIP receptor antagonizing effect of peptide-based competitive GIP receptor antagonist GIP-A (vs. saline (placebo)) in 10 healthy subjects during 1 hour hyperglycaemic clamps with and without concomitant iv infusion of GIP\[1-42\]. The intention is to establish GIP-A as a tool to eliminate glucose-dependent insulinotropic GIP signalling.

The study consists of four experimental days (A-D) with assessment of beta cell function during 12 mM-hyperglycaemic clamps with concomitant infusions of A) GIP\[1-42\], B) GIP-A, C) GIP\[1-42\] + GIP-A, or D) saline (placebo).

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-21
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria

• Medication, Diabetes type 1 or 2, BMI > 25, first degree relatives with Type 2 Diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GIP-A	GIP-A	Infusion of GIP-A alone
GIP-A + GIP(1-42)	GIP-A	Infusion of GIP-A and GIP(1-42)
GIP-A + GIP(1-42)	GIP(1-42)	Infusion of GIP-A and GIP(1-42)
Placebo	Saline	Infusion of saline
GIP(1-42)	GIP(1-42)	Infusion of agonist, GIP(1-42)

Primary Outcome Measures

Name	Time	Method
Insulin levels	65 minutes	Serum-insulin AUC (area under the curve for hyperglycemic clamp period)

Trial Locations

Locations (1)

Center for Diabetes Research; 🇩🇰 Copenhagen, Gentofte, Denmark