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

This study has been completed.
Sponsor:
Collaborator:
University of Kentucky
Information provided by (Responsible Party):
Robert Lodder, Spherix Incorporated
ClinicalTrials.gov Identifier:
NCT00955747
First received: August 7, 2009
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

The purpose of this trial was to evaluate the effectiveness and safety of Naturlose (Tagatose) for glycemic control in people with Type 2 diabetes who were not taking other medications for the condition and who were under diet control and exercise.

The study lasted approximately one year. HbA1c was monitored every 2 months after entry into the study. Safety and tolerance for tagatose were assessed every 2 months throughout the study. A total of 14 visits were made to the study site.


Condition Intervention Phase
Type 2 Diabetes
Drug: Tagatose
Drug: Sugar Substitute Splenda
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:
  • Change in Hemoglobin A1C Level From Baseline [ Time Frame: 1 year from baseline ] [ Designated as safety issue: No ]
    The primary efficacy variable will be the change in HbA1c level from baseline. Changes from baseline in HbA1c level at each visit will be assessed with the use of linear model(ANCOVA) to adjust for any baseline difference, as well as the stratification factor.


Enrollment: 494
Study Start Date: April 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Substitute Splenda
1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
Drug: Sugar Substitute Splenda
1.5 g powder tid
Other Name: Sugar Substitute Splenda
Experimental: Tagatose
15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
Drug: Tagatose
powder; 15 grams three times daily; one year
Other Name: Naturlose

  Show Detailed Description

  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
Diabetomics
Hyderabad, Andhra Pradesh, India, 500034
Global Hospital
Hyderabad, Andhra Pradesh, India, 500004
Sai Venkateshwara Multi Speciality Hospital and Critical Care Center
Hyderabad, Andhra Pradesh, India, 500079
Consultant General Medicine and Diabetes
Hyderabad, Andhra Pradesh, India, 500035
Diacon Hospital and Research Centre
Bangalore, Karnataka, India, 587010
Padmashree Diagnostics
Bangalore, Karnataka, India, 560040
St. John National Academy of Health Sciences
Bangalore, Karnataka, India, 560034
Department of Medicine
Belgaum, Karnataka, India, 590010
Hubli Clinical Research Centre
Hubli, Karnataka, India, 587002
KMC Hospital
Mangalore, Karnataka, India, 575001
Muller Medical College
Mangalore, Karnataka, India, 575002
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
ACEER
Chennai, Tamil Nadu, India, 641020
Moses Diabetes and Medical Center
Chennai, Tamil Nadu, India, 600107
Coimbatore Diabetes Foundation
Coimbatore, Tamil Nadu, India, 641002
Apollo Specialty Hospitals,KK
Madurai, Tamil Nadu, India, 625020
Trichy Diabetes Speciality Centre (P) Ltd.
Tiruchirapalli, Tamil Nadu, India, 620018
Sponsors and Collaborators
Robert Lodder
University of Kentucky
Investigators
Study Director: Robert Lodder University of Kentucky
  More Information

No publications provided

Responsible Party: Robert Lodder, Professor, Spherix Incorporated
ClinicalTrials.gov Identifier: NCT00955747     History of Changes
Obsolete Identifiers: NCT00451477
Other Study ID Numbers: 70971-004
Study First Received: August 7, 2009
Results First Received: December 5, 2013
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Tagatose
Chelating Agents
Iron Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents

ClinicalTrials.gov processed this record on November 20, 2014