A Research Study Comparing a New Medicine Oral Semaglutide to Sitagliptin in People With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Semaglutide.

This study compares 2 medicines for type 2 diabetes: oral semaglutide (a new medicine) and sitagliptin (a medicine doctors can already prescribe).

Participants will either get oral semaglutide or sitagliptin - which treatment is decided by chance.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

1441 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 60 days or more prior to day of screening.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: family or personal history of multiple endocrine neoplasia type 2 (men 2) or medullary thyroid carcinoma (mtc). family is defined as a first degree relative; history or presence of pancreatitis (acute or chronic); history of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

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

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

It started in 2019-07-29 with completion listed for 2021-10-27.

It ran at 93 sites in China (59), South Africa (10), Romania (6), Czechia (5), Taiwan (4) and Brazil (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline to Week 26 in Glycated Haemoglobin (HbA1c) (%) (time frame: From baseline to week 26).

It also tracked 43 secondary outcomes, for example Change From Baseline to Week 26 in Fasting Plasma Glucose (FPG), Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile, Change From Baseline to Week 26 in 7 Point SMPG Profile: Mean Postprandial Increment (Over All Meals), Time to Rescue Medication, Change From Baseline to Week 26 in Body Weight (Kilogram [kg]) and Percentage Change From Baseline to Week 26 in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 1441 people.

With 1441 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.