CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 494 enrolled
Drug / intervention
Tagatose +1 moredrug
Likely dose
Sugar Substitute Splenda 1.5 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00955747
NCT00955747Phase 3Completed
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Effects of Naturlose (Tagatose) on Glycemic Control and Safety of Naturlose Over One Year in Subjects With Type 2 Diabetes Under Diet Control and Exercise

Robert Lodder·interventional·Posted Aug 10, 2009·Updated Nov 19, 2014

In Brief

A Phase 3 clinical trial evaluating Tagatose and Sugar Substitute Splenda for Type 2 Diabetes. Completed, enrolled 494 participants across 46 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesIndia, United States
CollaboratorsUniversity of Kentucky

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 10, 2009
Enrollment StartApr 1, 2007
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 16.9 years ago

Interventions

Tagatosedrug

powder; 15 grams three times daily; one year

Sugar Substitute Splendadrug

1.5 g powder tid