Multiple Dose Trial Examining Dose Range, Escalation and Efficacy of Oral Semaglutide in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 2) is built around Semaglutide.

This trial is conducted globally.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 632 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: BMI above or equal to 25 and below or equal to 40 kg/m\^2.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: subjects on selected oral medication with a narrow therapeutic window, such as warfarin, digoxin, tricyclic antidepressants, lithium, aminophylline, theophylline and anticonvulsants; history of chronic pancreatitis or idiopathic acute pancreatitis; chronic malabsorption, regardless of aetiology.

How the Study Was Run

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

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

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 2013-12-02 with completion listed for 2014-12-11.

It ran at 103 sites in United States (40), United Kingdom (8), Germany (7), Israel (7), Austria (6) and Canada (6).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 6 secondary outcomes, for example Change in Body Weight, Change in Waist Circumference, Change in Body Mass Index (BMI), Number of Treatment Emergent Adverse Events (TEAEs) Recorded and Number of Confirmed Hypoglycaemic Episodes Recorded.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 632 people.

With 632 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.