Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes

What Was Tested

This registered phase 2 trial tested Semaglutide.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

Placebo group.

The registry classes the interventions as drug and other.

More on the Plan

A parallel-group, double-blind, placebo-controlled, randomized study will rigorously test effects of semaglutide on the kidney.

Real-time continuous glucose monitoring will be used to control glycemia during study run-in (prior to randomization) and during active therapy, which investigators anticipate will lead to similar glycemic control according to treatment assignment and ability to assess effects independent of glycemia.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Adequate contraceptive method for females of child-bearing potential.

The full record lists 7 inclusion and 19 exclusion criteria; among the exclusions: personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (men 2) or thyroid nodule palpated by endocrinologist at screening; personal history of pancreatitis; current/planned pregnancy or nursing.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2024-04-05 with completion listed for 2027-06.

It ran at 4 sites in United States (3) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in urine albumin excretion (time frame: Baseline to 26 weeks).

It also tracked 5 secondary outcomes, for example Change in kidney cortical relaxation rates (R2*), Change in estimated glomerular filtration rate, Change in glucose time in range and Change in glucose coefficient of variation.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.