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Effect of Oral Contraceptives After Administration of Semaglutide in Subjects With Type 2 Diabetes
Plain-language guide to NCT01324505: phase 1 non-randomized trial of Semaglutide, 43 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01324505
- Phase
- phase 1
- Status
- completed
- Start
- 2011-03
- Completion (planned or actual)
- 2012-01
- Participants
- 43 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Semaglutide.
This clinical trial is conducted in Europe.
It had 1 arm (groups): One-sequence cross-over arm (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 43 actual participants took part.
It was open to women only 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 by a physician before any trial-related activities. BMI (Body Mass Index) between 18.5 - 35.0 kg/m\^2 (both inclusive).
The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial products or related products; previous participation in this trial. participation is defined as being dosed with either drug; treatment with antidiabetic drug other than metformin within the last 3 months.
How the Study Was Run
The set-up was non-randomized, crossover and open-label.
Each person switched between Semaglutide and the comparison at some point, usually with a gap in between.
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 2011-03 with completion listed for 2012-01.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Area under the ethinylestradiol concentration-time curve. Area under the levonorgestrel concentration-time curve.
It also tracked 4 secondary outcomes, for example Maximum oral contraceptive concentration, Area under the semaglutide concentration-time curve, Maximum semaglutide concentration and Percentage of subjects experiencing adverse events.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Semaglutide in 43 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.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
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.