Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

What Was Tested

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

This trial is conducted in Africa, North and South America, Asia and Europe.

It had three arms (groups): one (experimental), one (experimental) and Insulin glargine (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 1089 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: Male or female, 18 years or older at the time of signing informed consent.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: any disorder which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol; history of chronic or idiopathic acute pancreatitis; screening calcitonin value greater than or equal to 50 ng/l.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2014-08-04 with completion listed for 2015-09-03.

It ran at 231 sites in United States (136), France (19), India (15), United Kingdom (13), Germany (12) and Romania (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c From Baseline (time frame: Week 0, week 30).

It also tracked 7 secondary outcomes, for example Change in Body Weight From Baseline, Change in Fasting Plasma Glucose From Baseline, Change in Diastolic Blood Pressure, Change in Systolic Blood Pressure, Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™ and Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide and Insulin Glargine in 1089 people.

With 1089 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 and the Insulin Glargine compound page, all human trials.