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Naturlose (D-Tagatose) Efficacy Evaluation Trial (NEET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Spherix Incorporated.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
BioSpherix
Information provided by:
Spherix Incorporated
ClinicalTrials.gov Identifier:
NCT00955747
First received: August 7, 2009
Last updated: July 1, 2010
Last verified: May 2010
History of Changes
  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 3

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:

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 May 23, 2013