At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 161 enrolled
Drug / intervention
D-Tagatosedrug
Likely dose
Not stated in 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.
Dose Ranging Effects of Three Low-doses of Naturlose™ (Tagatose) on Glycemic Control and Safety of Naturlose™ (Tagatose) Over Six Months in Subjects With Mild Type 2 Diabetes Mellitus Under Control With Diet and Exercise.
In Brief
A Phase 2 clinical trial evaluating D-Tagatose for Type 2 Diabetes. Completed, enrolled 161 participants across 13 sites in 2 countries.
Detailed Summary
This study is a six-month, prospective, randomized, multicenter, single- blind, controlled clinical study to evaluate the effect of three low-doses of Naturlose (Tagatose) on glycemic control and safety in subjects with Type 2 diabetes under diet control and exercise. The subjects were randomized in one of the 3 arms receiving 2.5, 5 or 7.5 gm of Tagatose.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesIndia, United States
CollaboratorsUniversity of Kentucky
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedAug 2009
Primary CompletionAug 2010
TodayJul 2026
First PostedAug 19, 2009
Enrollment StartFeb 1, 2008
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.9 years ago
Interventions
D-Tagatosedrug
powder to be dissolved in water prior to dosage.