Naturlose (D-Tagatose) Efficacy Evaluation Trial - Full Text View

Sponsor:	Spherix Incorporated
Collaborator:	BioSpherix
Information provided by:	Spherix Incorporated
ClinicalTrials.gov Identifier:	NCT00955747

Purpose

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 Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Spherix Incorporated:

Primary Outcome Measures:

To evaluate a placebo-subtracted treatment effect of tagatose in glycemic control determined by a statistically significant decrease in hemoglobin A1c (HbA1c) levels. [ Time Frame: One Year ] [ Designated as safety issue: No ]

Estimated Enrollment:	550
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Sugar substitute	Drug: Placebo Sugar Substitute
Experimental: Tagatose	Drug: Tagatose powder; 15 grams three times daily; one year Other Name: Naturlose

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetics in accordance with WHO.
Male and female patients, between 18 and 75 years of age.
Diabetic patients who are not on medication for the disease. Patients may be treated with diet and exercise.
Normal blood creatine clearance and normal liver function test results.
BMI less than or equal to 45kg/m2.

Exclusion Criteria:

Treatment with sulfonylurea (e.g., Glyburide, Glipizide, Glimepiride, Chlorpropamide, Tolazamide, Acetohexamide, or Tolbutamide), TZDs, metformin, acarbose, Byetta, insulin, and any antidiabetic medications within the prior 3 months.
Therapy with beta-blockers or thiazide diuretics within the prior 3 months.
Pregnancy, breastfeeding, or intention of becoming pregnant or judged to be using inadequate contraceptive measure.
Documented gastrointestinal disease, or taking of medications likely to alter gut motility or absorption.
Receiving any investigational drug within 30 days of the baseline visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955747

Show 46 Study Locations

Sponsors and Collaborators

Spherix Incorporated

BioSpherix

More Information

No publications provided

Responsible Party:	Randy Brown, Chief of Operations, Spherix
ClinicalTrials.gov Identifier:	NCT00955747 History of Changes
Obsolete Identifiers:	NCT00451477
Other Study ID Numbers:	70971-004
Study First Received:	August 7, 2009
Last Updated:	July 1, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Tagatose
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012