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Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes
Plain-language guide to NCT01798264: phase 1 randomized trial of Exenatide, 44 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01798264
- Phase
- phase 1
- Status
- completed
- Start
- 2009-02
- Completion (planned or actual)
- 2009-05
- Participants
- 44 (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 1) is built around Exenatide.
Evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (experimental).
ITCA 650 (exenatide in DUROS).
ITCA 650 (exenatide in DUROS).
ITCA 650 (exenatide in DUROS).
The registry classes the interventions as drug.
Who Took Part
44 actual participants took part.
It was open to people of any sex aged from 30 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes \>6 months.
The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: prior treatment with exenatide; history of pancreatitis; history of medullary thyroid cancer or multiple endocrine neoplasia 2.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
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 2009-02 with completion listed for 2009-05.
It ran at 3 sites in United States (3).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Number of Subjects With Study Drug-Related Adverse Events (time frame: 4 weeks).
It also tracked 3 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline and Change in Weight From Baseline to 4 Weeks.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Exenatide in 44 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.