Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide.

The main purpose of this study is to compare the effects of semaglutide (Ozempic®) with the effects of other treatments for type 2 diabetes in a normal practice setting.

The participant will be assigned by chance (like flipping a coin) to one of the following treatment groups: Group 1: semaglutide (Ozempic®) (by injection into skin) Group 2: standard of care antidiabetic medication (oral or injectable).

The participant has an equal chance of being in either of the treatment groups.

It had two arms (groups): Semaglutide (experimental) and Standard of care (active comparator).

Participants will receive semaglutide subcutaneously (s.c.) in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.

Participants will receive standard of care in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.

The registry classes the interventions as drug.

Who Took Part

The registry lists 1278 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study. Male or female, age 18 years or older at the time of signing informed consent. Type 2 diabetes mellitus diagnosis. Treatment with either 1 or 2 oral antidiabetic medications. Recorded HbAlc value within the last 90 days prior to randomization.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: previous randomization in this study; contraindications to semaglutide according to the food and drug administration approved label; female who is pregnant, breastfeeding or intends to become pregnant.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-07-13 with completion listed for 2022-06-09.

It ran at 181 sites in United States (180) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 68 secondary outcomes, for example Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 1, Change in HbA1c (Percentage-point [%-Point]) From Baseline to Year 2, Number of Participants Who Attained Individualized HbA1c Target at Year 1 (Yes/No), Change in Body Weight (in Pounds) From Baseline to Year 1, Percentage Change in Body Weight From Baseline to Year 1 and Change in Systolic Blood Pressure (SBP) From Baseline to Year 1.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 1278 people.

With 1278 participants it is a large trial for this field.

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.