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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

  Show 46 Study Locations
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