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Naturlose (D-Tagatose) Efficacy Evaluation Trial

NCT00955747 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2014-11-19

Study results available
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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.

Conditions

Interventions

DRUG

Tagatose

powder; 15 grams three times daily; one year

DRUG

Sugar Substitute Splenda

1.5 g powder tid

Sponsors & Collaborators

  • University of Kentucky

    collaborator OTHER

  • Robert Lodder

    lead INDUSTRY

Principal Investigators

  • Robert Lodder · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States
  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00955747 on ClinicalTrials.gov