drugset / Trial / NCT00955747
Naturlose (D-Tagatose) Efficacy Evaluation Trial
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this trial was to evaluate the effectiveness and safety of Naturlose (Tagatose) for glycemic control in people with Type 2 diabetes who were not taking other medications for the condition and who were under diet control and exercise. The study lasted approximately one year. HbA1c was monitored every 2 months after entry into the study. Safety and tolerance for tagatose were assessed every 2 months throughout the study. A total of 14 visits were made to the study site.
Timeline
- Start
- 2007-04
- Primary completion
- 2010-10
- Completion
- 2010-10
Outcome
Met primary endpoint
registry analysis (superiority or other test); Sugar Substitute Splenda vs Tagatose; p <0.05; Mean Difference (Net) 0.5; ANCOVA NCT00955747 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tagatose | Small molecule | 15 g | — |