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

Sponsor
Asger Lund, MD
Study ID
NCT05078255
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 27, 2022
Status verified
Jan 2025
Primary completion
Jan 6, 2025
Completion
Jan 24, 2025

Study Design

Enrollment
61 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: placebo injections + placebo infusion
  • Experimental: Semaglutide 1.34 mg/ml injections + GIP infusion
  • Experimental: placebo injections + GIP infusion
  • Experimental: Semaglutide 1.34 mg/ml injections + placebo infusion

Primary Outcome Measure

Mean glucose levels (assessed by blinded continuous glucose monitoring (CGM)) [ Time Frame: 14-day mean glucose levels during the last 14 days of the intervention period as compared to 14-day mean glucose levels during the last 14 days of the run-in period. ]

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