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A Clinical Study to Evaluate the Effect of Naturlose (Tagatose)

This study has been completed.
Sponsor:
Collaborator:
University of Kentucky
Information provided by (Responsible Party):
Robert Lodder, Spherix Incorporated
ClinicalTrials.gov Identifier:
NCT00961662
First received: August 17, 2009
Last updated: November 1, 2014
Last verified: November 2014
  Purpose

This study is a six-month, prospective, randomized, multicenter, single- blind, controlled clinical study to evaluate the effect of three low-doses of Naturlose (Tagatose) on glycemic control and safety in subjects with Type 2 diabetes under diet control and exercise. The subjects were randomized in one of the 3 arms receiving 2.5, 5 or 7.5 gm of Tagatose.


Condition Intervention Phase
Type 2 Diabetes
Drug: D-Tagatose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Dose Ranging Effects of Three Low-doses of Naturlose™ (Tagatose) on Glycemic Control and Safety of Naturlose™ (Tagatose) Over Six Months in Subjects With Mild Type 2 Diabetes Mellitus Under Control With Diet and Exercise.

Resource links provided by NLM:


Further study details as provided by Spherix Incorporated:

Primary Outcome Measures:
  • Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus [ Time Frame: 6 months from baseline ] [ Designated as safety issue: No ]
    The primary efficacy parameter was a dichotomous variable: the treatment success as measured by a reduction from baseline HbA1c by at least 0.5 units after six months of treatment (i.e.,0.5% reduction in HbA1c after six months of treatment).


Secondary Outcome Measures:
  • Effects of Naturlose (Tagatose) on Other Glycemic Control Measurements Such as Plasma Glucose Concentrations and Plasma Lipids at Each Study Visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • A Decrease of ≥0.5% in HbA1c Level at Each Study Visit [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • A Decrease of ≥1% in HbA1c Level in Any of the Naturlose (Tagatose) Treatment Groups at Any Time Point Over the Duration of the Study [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • A Decrease of Fasting Plasma Glucose (FPG) Level Compared With Baseline Level at Any Time Point Over the Duration of the Study [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Body Weight Loss (Compared to Baseline) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 161
Study Start Date: February 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2.5 active
2.5 Active - 2.5 g D-tagatose given orally, three times daily, immediately prior to meals for 6 months.
Drug: D-Tagatose
powder to be dissolved in water prior to dosage.
Other Name: Naturlose
Active Comparator: 5.0 mid dose
5.0 mid dose - 5.0 g D-tagatose given orally, three times daily, immediately prior to meals for 6 months.
Drug: D-Tagatose
powder to be dissolved in water prior to dosage.
Other Name: Naturlose
Active Comparator: 7.5 high dose
7.5 high dose - 7.5 g D-tagatose given orally, three times daily, immediately prior to meals for 6 months.
Drug: D-Tagatose
powder to be dissolved in water prior to dosage.
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 45 kg/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: NCT00961662

Locations
United States, California
Probe Clinical Research Corp.
Garden Grove, California, United States, 92843
United States, Florida
Pharmax Research Clinic
Miami, Florida, United States, 33126
United States, Georgia
PMI Health Research Group
Atlanta, Georgia, United States, 30312
Ialim Clinical Research Center
Decatur, Georgia, United States, 30035
United States, Texas
Juno Research, LLC
Houston, Texas, United States, 77036
India
Diabetes Care and Research Centre
Patna, Bihar, India, 800 020
Bharti Research Institute of Diabetes and Endocrinology
Karnal, Haryana, India, 132 001
Bangalore Endocrinology and Diabetes Research Centre
Bangalore, Karnataka, India, 560 003
Medisys Clinisearch India Pvt. Ltd.
Bangalore, Karnataka, India, 560 043
Belgaum Diabetes Centre
Belgaum, Karnataka, India, 590 001
Krishna Diabetes Clinic and Educational Research Centre
Bhopal, Madhya Pradesh, India, 462 003
Diabetes Thyroid Hormone Research Institute Pvt. Ltd
Indore, Madhya Pradesh, India, 452 001
Research Health Institute in Diabetes Endocrinology and Metabolism
Mumbai, Maharashtra, India, 400 014
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, PhD, Spherix Incorporated
ClinicalTrials.gov Identifier: NCT00961662     History of Changes
Other Study ID Numbers: 70971-005
Study First Received: August 17, 2009
Results First Received: December 5, 2013
Last Updated: November 1, 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 25, 2014