A Trial Investigating the Effects of Semaglutide on ß-cell Function in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 1) is built around Semaglutide.

This trial is conducted in Europe.

The aim of the trial is to investigate the effects of semaglutide on ß-cell function in subjects with type 2 diabetes.

It had three arms (groups): Semaglutide (experimental), Placebo (placebo comparator) and Healthy subjects (no intervention).

Total of 12 visits.

Total of 12 visits.

Total of 2 visits.

The registry classes the interventions as drug.

Who Took Part

87 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Age: 18-64 years (both inclusive) at the time of signing the informed consent. For subjects with type 2 diabetes:. Male and female subjects diagnosed with type 2 diabetes. Body Mass Index (BMI) between 20.0-35.0 kg/m\^2 (both inclusive). For healthy control group for graded glucose infusion:.

The full record lists 10 inclusion and 7 exclusion criteria; among the exclusions: history of drug/chemical substance abuse within 1 year prior to screening, or a positive result in the urine drug test; history of alcohol abuse within 1 year prior to screening, or a positive result in the alcohol breath test; smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day).

How the Study Was Run

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

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 and investigator.

It started in 2014-08-11 with completion listed for 2015-05-11.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the serum insulin concentration time curve from 0 to 10 minutes after a [amount hidden] glucose bolus i.v. infusion (IVGTT,intravenous glucose tolerance test) over 2 minutes. Area under the serum insulin concentration time curve from 10-120 minutes after a [amount hidden] glucose bolus i.v. infusion (IVGTT).

It also tracked 6 secondary outcomes, for example Area under the insulin secretion rate (ISR)-time curve within 0 to 10 min after i.v. glucose challenge, Area under the ISR-time curve within 10 to 120 min after i.v. glucose challenge and 24-hour plasma glucose, glucagon, serum insulin, and C-peptide measured as total AUC0-24h during a test day with 3 standardised meals.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 87 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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