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Naturlose (D-Tagatose) Efficacy Evaluation Trial (NEET)
This study is currently recruiting participants.
Verified by Spherix Incorporated, August 2009
First Received: August 7, 2009   Last Updated: August 11, 2009   History of Changes
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: 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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diets 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: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sugar substitute: Placebo Comparator Drug: Placebo
Sugar Substitute
Tagatose: Experimental Drug: Tagatose
powder; 15 grams three times daily; one year

  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

Contacts
Contact: Randy Brown 301.957.4275 rbrown@spherix.com
Contact: Spherix 301.897.2540

  Hide Study Locations
Locations
United States, Alabama
Medical Affiliated Research Center Recruiting
Huntsville, Alabama, United States, 35801
Contact: LuAnne Boggs     256-533-6603     lboggs@marc-research.com    
Principal Investigator: Michael Carter            
Simon Williamson Clinc Recruiting
Hueytown, Alabama, United States, 35023
Contact: Donna Squires     205-491-3299 ext 8     dsquires@sdr.us    
Principal Investigator: Michael Rosemore            
United States, Arkansas
NEA Clinical-Research Solutions Recruiting
Jonesboro, Arkansas, United States, 72404
Contact: Brenda Graf     870-275-5558     b_graf@neaclinic.com    
Principal Investigator: Timothy Dow            
United States, California
Alia Clinical Research Recruiting
Huntington Park, California, United States, 90255
Contact: Angela Kassabian     323-581-5215     aliacrinc@aol.com    
United States, Georgia
Atlanta Primary Care Center Recruiting
Atlanta, Georgia, United States, 30312
Contact: Orlando McCleod     404-525-5787     mccleod@pmirsearch.com    
Principal Investigator: Delphanie Head            
River Birch Research Alliance Recruiting
Blue Ridge, Georgia, United States, 30513
Contact: Beth Merry     706-258-4129     bmerry@riverstonemd.com    
Contact: Maxwell Eblaghie         meblaghie@riverstonemd.com    
Principal Investigator: Raymond Tidman            
United States, Illinois
John Stroger Cook County Hospital Recruiting
Chicago, Illinois, United States, 60612
Contact: Melody Smith     312-864-0539     melodybsmith@yahoo.com    
Principal Investigator: Leon Fogelfeld            
Affinity Healthcare Recruiting
Arlington Heights, Illinois, United States, 60004
Contact: Carol Tietz     847-890-6328     ctietz@affinitydocs.com    
Principal Investigator: Carl Lang            
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40502
Contact: Linda Barber     859-233-4511 ext 4427     linda.barber2@va.gov    
Principal Investigator: Dennis Karounos            
United States, Massachusetts
Activmed Practices and Research Recruiting
Haverhill, Massachusetts, United States, 01830
Contact: Terry Stubbs     978-372-7252 ext 15     tstubbs@eccresearch.com    
Principal Investigator: Peter Rees            
United States, Nevada
Nevada Alliance Against Diabetes Recruiting
Las Vegas, Nevada, United States, 89101
Contact: Lourdes Guzman     702-207-0440     lguzman@naadiabetes.com    
Contact: Olga Lumsden     702-207-0440     olumsden@naadiabetes.org    
Principal Investigator: Rubin Saavedra            
United States, New Jersey
Hamilton Clinical Research Recruiting
Trenton, New Jersey, United States, 08690
Contact: Pam Ford     609-586-0952     pfordnp@comcast.net    
Principal Investigator: Edward Laub            
Cedar Clinical Research Recruiting
Oradell, New Jersey, United States, 07649
Contact: Lucinda Sariti     201-928-0101     cedarmedical@hotmail.com    
Contact: Marc Polimeni     201-928-0101     dp935@optonline.net    
Principal Investigator: Marc Polimeni            
Ocean County Clinical Research Recruiting
Brick, New Jersey, United States, 08724
Contact: Neha Patel     732-892-0961     ndpatel04@hotmail.com    
Principal Investigator: Michael Rothberg            
United States, Ohio
ReSevo, LLC Recruiting
Cuyahoga Falls, Ohio, United States, 44223
Contact: Pam Surko     330-940-2625     resevo.llc@hotmail.com    
Principal Investigator: Patrick Blakeslee            
United States, Texas
TTS Research/Hill Country Medical Recruiting
Boerne, Texas, United States, 78006
Contact: Mary Jimenez     210-632-0934     mjimenez@gvtc.com    
Contact: Stephanie Valdez     830-816-2552     valdezs93@yahoo.com    
Principal Investigator: Richard Martinez            
Cetero Research Recruiting
San Antonio, Texas, United States, 78229
Contact: Arthur Ramos     210-615-5565     art.ramos@cetero.com    
Principal Investigator: Jolene Berg            
Galenos Research Recruiting
Dallas, Texas, United States, 75251
Contact: Eunice Allen     972-233-5410     eallen@galenosresearch.com    
Principal Investigator: Rafael Canadas-Zizzias            
Capital Medical Clinic Recruiting
Austin, Texas, United States, 78705
Contact: Kim McNeff     512-371-3537     research@capmedaustin.com    
Principal Investigator: Kenneth Kroll            
Century Clinical Research Recruiting
Houston, Texas, United States, 77036
Contact: Leticia Foronda     713-777-7509        
Principal Investigator: Dac Vu            
United States, Utah
Optimum Clinical Research Recruiting
Salt Lake City, Utah, United States, 84102
Contact: Olivia Walton     801-363-7574     admin@ocresearch.com    
Principal Investigator: Jackson Rhudy            
India, Andhra Pradesh
Medwin Hospital Recruiting
Hyderabad, Andhra Pradesh, India, 500001
Contact     +91-9848115322        
Principal Investigator: K. D Modi            
Dept. of Endocrinology and Diabetes Recruiting
Hyderabad, Andhra Pradesh, India, 500063
Contact     +91-9849597507        
Principal Investigator: Rakesh Sahay            
Global Hospital Recruiting
Hyderabad, Andhra Pradesh, India, 500004
Contact     09980303481        
Principal Investigator: Ashok K Dash            
Diabetomics Recruiting
Hyderabad, Andhra Pradesh, India, 500034
Contact     099805093957        
Principal Investigator: Naga J Borra            
Consultant General Medicine and Diabetes Recruiting
Hyderabad, Andhra Pradesh, India, 500035
Contact     +91-9985642450        
Principal Investigator: Ravi Jayam            
Sai Venkateshwara Multi Speciality Hospital and Critical Care Center Recruiting
Hyderabad, Andhra Pradesh, India, 500079
Principal Investigator: G Venkata Ramana            
India, Karnataka
Hubli Clinical Research Centre Recruiting
Hubli, Karnataka, India, 587002
Contact     +918362261652        
Principal Investigator: Ramesh Babruwad            
Muller Medical College Recruiting
Mangalore, Karnataka, India, 575002
Contact     098451 38717        
Principal Investigator: Roshan M            
Recruiting
Bangalore, Karnataka, India, 587010
Contact     (984) 401-8367        
Principal Investigator: S R Arvind            
Padmashree Diagnostics Recruiting
Bangalore, Karnataka, India, 560040
Contact     +919448057639        
Principal Investigator: Sai Pradeep            
Department of Medicine Recruiting
Belgaum, Karnataka, India, 590010
Contact     +91 9448036185        
Principal Investigator: Jayaprakash Appajigol            
Department of Medicine Recruiting
Mysore, Karnataka, India, 570004
Contact     +91 9448055503        
Principal Investigator: Y.S. Ravi Kumar            
St. John National Academy of Health Sciences Recruiting
Bangalore, Karnataka, India, 560034
Contact     +91 9848115322        
Principal Investigator: Ganapathi Bantwal            
KMC Hospital Recruiting
Mangalore, Karnataka, India, 575001
Contact     +91-9845348475        
Principal Investigator: Satish Rao            
India, Kerala
Health and Research Centre Recruiting
Trivandrum, Kerala, India, 695011
Contact     +91 9447058561        
Principal Investigator: Rajendran K            
Palakkad Diabetic Center Recruiting
Palakkad, Kerala, India, 678013
Contact     +919847342655        
Principal Investigator: A P Radhakrishnan            
India, Madhya Pradesh
Suyash Hospital Pvt. Ltd. Recruiting
Indore, Madhya Pradesh, India
Contact     0 9826019330        
Principal Investigator: Gajendra Bhandari            
India, Maharashtra
Deshmukh Clinic Recruiting
Pune, Maharashtra, India, 411030
Contact     0 9850811450        
Principal Investigator: Vaishali Deshmukh            
Sunil's Diabetes Care n' Research Centre Pvt. Ltd. Recruiting
Nagpur, Maharashtra, India, 440010
Principal Investigator: Sunil Surajprasad Gupta            
India, Rājasthān
D- Clinarch Recruiting
Jaipur, Rājasthān, India, 302016
Principal Investigator: Rakesh Parikh            
India, Tamil Nadu
Recruiting
Chennai, Tamil Nadu, India, 600107
Contact     (984) 005-0973        
Principal Investigator: Anand Moses            
Recruiting
Coimbatore, Tamil Nadu, India, 641002
Contact     (91936) 262-2723        
Principal Investigator: V Sekar            
Recruiting
Madurai, Tamil Nadu, India, 625020
Contact     (91984) 328-0340        
Principal Investigator: Paul Sudakar            
Recruiting
Chennai, Tamil Nadu, India, 641020
Contact     (984) 097-6251        
Principal Investigator: V Kumaravel            
Trichy Diabetes Speciality Centre (P) Ltd. Recruiting
Tiruchirapalli, Tamil Nadu, India, 620018
Contact     +91-431-2742091        
Principal Investigator: M. Shunmugavelu            
Sponsors and Collaborators
Spherix Incorporated
BioSpherix
  More Information

No publications provided

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009



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