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Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus
Plain-language guide to NCT00943917: phase 2 randomized trial of Exenatide, 155 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00943917
- Phase
- phase 2
- Status
- completed
- Start
- 2009-08
- Completion (planned or actual)
- 2010-08
- Participants
- 155 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Exenatide.
It had nine arms (groups): one (experimental), one (experimental), Exenatide Injection (active comparator), ITCA 650 20/20 (experimental) and ITCA 650 20/60 (experimental).
The registry classes the interventions as drug and other.
Who Took Part
Enrollment: 155 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Males or females age 18-70 years. Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1. On a stable (\> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;.
The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: prior treatment with exenatide; history of type 1 diabetes and/or history of diabetic ketoacidosis; body mass index ≥ 40 kg/m2;.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.
The Exenatide group and the comparison group ran side by side rather than switching.
Being open-label, the Exenatide study did not mask who received what.
It started in 2009-08 with completion listed for 2010-08.
It ran at 50 sites in United States (50).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Mean Change in HbA1c (Per Protocol) (time frame: Day 0 and Week 12). Mean Change in HbA1c (ITT) (time frame: Day 0 to Week 12). Mean Change in HbA1c (Per Protocol) (time frame: Day 0 to Week 24).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Exenatide in 155 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.