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Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER [amount hidden] Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes
Plain-language guide to NCT01885208: phase 3 randomized trial of Semaglutide and Exenatide, 813 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01885208
- Phase
- phase 3
- Status
- completed
- Start
- 2013-12-02
- Completion (planned or actual)
- 2015-07-13
- Participants
- 813 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Semaglutide and Exenatide.
This trial is conducted in Europe and North and South America.
It had two arms (groups): one (experimental) and one (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 813 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.
The full record lists 0 inclusion and 1 exclusion criteria.
How the Study Was Run
Design: randomized, parallel-group and open-label.
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.
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 2013-12-02 with completion listed for 2015-07-13.
It ran at 146 sites in United States (76), Netherlands (9), France (8), Germany (8), Italy (7) and Greece (6).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 56).
It also tracked 5 secondary outcomes, for example Change From Baseline in Body Weight, Change From Baseline in Fasting Plasma Glucose (FPG), Change From Baseline in Systolic and Diastolic Blood Pressure and Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Semaglutide and Exenatide in 813 people.
With 813 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 Exenatide compound page, all human trials.
Our Notes on the Compounds
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.