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

Plain-language guide to NCT05078255: not phased randomized trial of Semaglutide and GIP (Gastric Inhibitory Polypeptide), 61 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05078255
Phase
not phased
Status
completed
Start
2022-01-27
Completion (planned or actual)
2025-01-06
Participants
61 (actual)
Design
randomized, triple-blind, treatment
Conditions studied
Type 2 Diabetes; Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Semaglutide and GIP (Gastric Inhibitory Polypeptide).

However, the contribution of GIP receptor activation to these effects remains unknown.

It had four arms (groups): placebo injections + placebo infusion (placebo comparator), one (experimental), placebo injections + GIP infusion (experimental) and one (experimental).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 61 actual participants took part.

It was open to people of any sex aged from 18 years up to 74 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Men and women 18 to 74 years of age (both inclusive) at the time of signing informed consent. Diagnosed with type 2 diabetes for at least six months. BMI ≥25 to ≤50 kg/m2. Stable body weight (less than 3 kg self-reported change during the previous 90 days).

The full record lists 7 inclusion and 39 exclusion criteria; among the exclusions: diagnosed with type 1 diabetes; known or suspected hypersensitivity to trial product or related products; previous participation in this trial. participation is defined as signed informed consent. participation is allowed if the protocol is updated to a newer version.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2022-01-27 with completion listed for 2025-01-06.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean glucose levels (assessed by blinded continuous glucose monitoring (CGM)).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide and GIP (Gastric Inhibitory Polypeptide) in 61 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page and the GIP (Gastric Inhibitory Polypeptide) compound page, all human trials.

Our Notes on the Compounds

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

GIP (Gastric Inhibitory Polypeptide): A 42-amino-acid gut hormone that boosts insulin release after meals; one of the two receptors tirzepatide acts on.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.