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A Clinical Study to Evaluate the Effect of Naturlose (Tagatose)

NCT00961662 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2014-11-06

Study results available
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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.

Conditions

Interventions

DRUG

D-Tagatose

powder to be dissolved in water prior to dosage.

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
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-08-31
Completion
2010-08-31

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 NCT00961662 on ClinicalTrials.gov