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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Simon Williamson Clinc
Hueytown, Alabama, United States, 35023
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
United States, Arkansas
NEA Clinical-Research Solutions
Jonesboro, Arkansas, United States, 72404
United States, California
Alia Clinical Research
Huntington Park, California, United States, 90255
United States, Georgia
Atlanta Primary Care Center
Atlanta, Georgia, United States, 30312
River Birch Research Alliance
Blue Ridge, Georgia, United States, 30513
United States, Illinois
Affinity Healthcare
Arlington Heights, Illinois, United States, 60004
John Stroger Cook County Hospital
Chicago, Illinois, United States, 60612
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40502
United States, Massachusetts
Activmed Practices and Research
Haverhill, Massachusetts, United States, 01830
United States, Nevada
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States, 89101
United States, New Jersey
Ocean County Clinical Research
Brick, New Jersey, United States, 08724
Cedar Clinical Research
Oradell, New Jersey, United States, 07649
Hamilton Clinical Research
Trenton, New Jersey, United States, 08690
United States, Ohio
ReSevo, LLC
Cuyahoga Falls, Ohio, United States, 44223
United States, Texas
Capital Medical Clinic
Austin, Texas, United States, 78705
TTS Research/Hill Country Medical
Boerne, Texas, United States, 78006
Galenos Research
Dallas, Texas, United States, 75251
Century Clinical Research
Houston, Texas, United States, 77036
Cetero Research
San Antonio, Texas, United States, 78229
United States, Utah
Optimum Clinical Research
Salt Lake City, Utah, United States, 84102
India
Medwin Hospital
Hyderabad, Andhra Pradesh, India, 500001
Dept. of Endocrinology and Diabetes
Hyderabad, Andhra Pradesh, India, 500063
Global Hospital
Hyderabad, Andhra Pradesh, India, 500004
Diabetomics
Hyderabad, Andhra Pradesh, India, 500034
Consultant General Medicine and Diabetes
Hyderabad, Andhra Pradesh, India, 500035
Sai Venkateshwara Multi Speciality Hospital and Critical Care Center
Hyderabad, Andhra Pradesh, India, 500079
St. John National Academy of Health Sciences
Bangalore, Karnataka, India, 560034
Bangalore, Karnataka, India, 587010
Padmashree Diagnostics
Bangalore, Karnataka, India, 560040
Department of Medicine
Belgaum, Karnataka, India, 590010
Hubli Clinical Research Centre
Hubli, Karnataka, India, 587002
Muller Medical College
Mangalore, Karnataka, India, 575002
KMC Hospital
Mangalore, Karnataka, India, 575001
Department of Medicine
Mysore, Karnataka, India, 570004
Palakkad Diabetic Center
Palakkad, Kerala, India, 678013
Health and Research Centre
Trivandrum, Kerala, India, 695011
Suyash Hospital Pvt. Ltd.
Indore, Madhya Pradesh, India
Sunil's Diabetes Care n' Research Centre Pvt. Ltd.
Nagpur, Maharashtra, India, 440010
Deshmukh Clinic
Pune, Maharashtra, India, 411030
D- Clinarch
Jaipur, Rājasthān, India, 302016
Chennai, Tamil Nadu, India, 600107
Chennai, Tamil Nadu, India, 641020
Coimbatore, Tamil Nadu, India, 641002
Madurai, Tamil Nadu, India, 625020
Trichy Diabetes Speciality Centre (P) Ltd.
Tiruchirapalli, Tamil Nadu, India, 620018
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 July 20, 2014