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Sponsors and Collaborators: |
Spherix Incorporated BioSpherix |
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Information provided by: | Spherix Incorporated |
ClinicalTrials.gov Identifier: | NCT00955747 |
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 |
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Type 2 Diabetes |
Drug: Tagatose Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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 |
Estimated Enrollment: | 550 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Sugar substitute: Placebo Comparator |
Drug: Placebo
Sugar Substitute
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Tagatose: Experimental |
Drug: Tagatose
powder; 15 grams three times daily; one year
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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 | rbrown@spherix.com |
Contact: Spherix | 301.897.2540 |
Responsible Party: | Spherix ( Randy Brown, Chief of Operations ) |
Study ID Numbers: | 70971-004 |
Study First Received: | August 7, 2009 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00955747 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Tagatose Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Chelating Agents Endocrinopathy Glucose Metabolism Disorders Iron Metabolic Disorder |
Tagatose Metabolic Diseases Molecular Mechanisms of Pharmacological Action Diabetes Mellitus, Type 2 Iron Chelating Agents |
Diabetes Mellitus Endocrine System Diseases Chelating Agents Glucose Metabolism Disorders Pharmacologic Actions |