Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes and Moderate Renal Impairment

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

This trial is conducted globally.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 324 actual participants took part.

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: 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. Male or female, age above or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening. 1-2 of the following oral anti-diabetic drugs:.

The full record lists 11 inclusion and 15 exclusion criteria; among the exclusions: any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol; family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma; history of pancreatitis (acute or chronic).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2016-09-20 with completion listed for 2018-04-10.

It ran at 117 sites in United States (60), Russia (19), United Kingdom (9), Denmark (7), Finland (7) and Israel (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: Week 0, week 26).

It also tracked 39 secondary outcomes, for example Change in Body Weight (kg), Change in FPG, Change in Body Weight (%), Change in BMI, Change in Waist Circumference and Change in Total Cholesterol (Ratio to Baseline).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 324 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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