NCT05078255

The Separate and Combined Effects of Long-term GIP and GLP-1 Receptor Activation in Patients with Type 2 Diabetes

Completed NA Last updated 14 March 2025

What this trial tests

NA trial testing Semaglutide 1.34 MG/ML [Ozempic] in Type 2 Diabetes in 61 participants. Completed in 24 January 2025.

Timeline

27 January 2022

Primary endpoint
6 January 2025

24 January 2025

Quick facts

Lead sponsor	Asger Lund, MD
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	61
Start date	27 January 2022
Primary completion	6 January 2025
Estimated completion	24 January 2025
Sites	1 location across Denmark

Drugs / interventions tested

• Semaglutide 1.34 MG/ML [Ozempic] — full drug profile →
• Glucose-dependent insulinotropic polypeptide (GIP) — full drug profile →
• Semaglutide 1.34 mg/ml placebo
• GIP placebo

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →
• Obesity — all drugs for Obesity →

Sponsor

Asger Lund, MD — full company profile →

Who can join

Adults 18 to 74, any sex, with Type 2 Diabetes or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Due to reports of a severely reduced insulinotropic effect of the incretin hormone glucose-dependent insulinotropic polypeptide (GIP) in type 2 diabetes (T2D), GIP has not been considered therapeutically viable in T2D. Recently, however, tirzepatide, a novel dual incretin receptor agonist (activating both the GIP receptor and the glucagon-like peptide 1 (GLP-1) receptor) demonstrated massive improvements in glycaemic control and robust body weight losses; greater than observed with the GLP-1 receptor agonist semaglutide. However, the contribution of GIP receptor activation to these effects remains unknown. The present study will evaluate the glucose-lowering effect of GIP in the context of pharmacological GLP-1 receptor activation in patients with T2D.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transforming obesity: The advancement of multi-receptor drugs.
   Kusminski CM, Perez-Tilve D, Müller TD, DiMarchi RD, et al · · 2024 · cited 77× · PMID 39059360 · DOI 10.1016/j.cell.2024.06.003
2. Separate and combined effects of long-term GIP and GLP-1 receptor activation in patients with type 2 diabetes: a structured summary of a study protocol for a double-blind, randomised, placebo-controlled clinical trial.
   Helsted MM, Gasbjerg LS, Vilsbøll T, Nielsen CK, et al · · 2023 · cited 1× · PMID 36849212 · DOI 10.1136/bmjopen-2022-065736
3. Effects of a 6-week subcutaneous infusion of native GIP alone or as add-on to semaglutide in people with type 2 diabetes: a single-centre, double-blind, parallel-group, randomised, placebo-controlled trial.
   Helsted MM, Fonnesbech-Wulff C, Schaltz NL, Lund IW, et al · · 2026 · PMID 42173109 · DOI 10.1016/s2213-8587(26)00075-6