Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
BioSpherix Spherix |
---|---|
Information provided by: | BioSpherix |
ClinicalTrials.gov Identifier: | NCT00451477 |
The purpose of this trial is to evaluate the effectiveness and safety of Naturlose (Tagatose) for glycemic control in people with Type 2 diabetes who are not taking other medications for the condition and who are under diet control and exercise.
The study will last approximately one year. HbA1c will be monitored every 2 months after entry into the study. Safety and tolerance for tagatose will be assessed every 2 months throughout the study. A total of 14 visits will be made to the study site.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes |
Drug: Tagatose |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Randy Brown | 301.957.4275 |
Responsible Party: | Spherix ( Randy Brown, Chief of Operations ) |
Study ID Numbers: | 70971-004 |
Study First Received: | March 21, 2007 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00451477 |
Health Authority: | United States: Food and Drug Administration |
Tagatose Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Iron |
Molecular Mechanisms of Pharmacological Action Iron Chelating Agents Chelating Agents Pharmacologic Actions |