← Human Trials & Peer-Reviewed Studies
Extension Study for 2993-112
Plain-language guide to NCT01789957: phase 3 interventional trial of Exenatide, 225 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01789957
- Phase
- phase 3
- Status
- completed
- Start
- 2002-09
- Completion (planned or actual)
- 2004-06
- Participants
- 225 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Exenatide.
Subjects completing Protocol 2993-112 are eligible to enroll.
It had 1 arm (groups): Open-label AC2993 (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 225 actual participants took part.
It was open to people of any sex aged from 16 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Has completed the 30-week triple-blind treatment initiation/active treatment periods in Protocol 2993-112, including all procedures required at the study termination visit (Week 30). Able to understand and sign a Protocol 2993-112E-specific informed consent form, communicate with the investigator, and understand and comply with the protocol requirements. Has not completed Protocol 2993-112. Female individuals who are pregnant, lactating, or planning to become pregnant.
The full record lists 5 inclusion and 0 exclusion criteria.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the Exenatide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2002-09 with completion listed for 2004-06.
It ran at 226 sites in United States (219) and Canada (7).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change in HbA1c from Day 1 of Protocol 2993-112 to Week 52 (or termination) (time frame: Day 1 of study 2993-112 through extension study termination (up to Week 52)). Change in body weight from Day 1 of Protocol 2993-112 to Week 52 (or termination) (time frame: Day 1 of study 2993-112 through extension study termination (up to Week 52)).
What This Means in Plain Language
Put simply, this is a phase 3 trial of Exenatide in 225 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Exenatide compound page, all human trials.
Our Notes on the Compound
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.