drugset / Trial / NCT00955747

Naturlose (D-Tagatose) Efficacy Evaluation Trial

NCT00955747 ↗

Phase 3 Completed 494 enrolled Robert Lodder University of Kentucky · collab
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

EvaluationDrugModalityDoseRoute
Subject Tagatose Small molecule 15 g —