A Clinical Study to Evaluate the Effect of Naturlose (Tagatose) - Full Text View

Sponsor:	Spherix Incorporated
Collaborator:	BioSpherix
Information provided by:	Spherix Incorporated
ClinicalTrials.gov Identifier:	NCT00961662

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 will be randomized in one of the 3 arms receiving 2.5, 5 or 7.5 gm of Tagatose. This trial is already on-going in the USA, and is intended to be conducted at 25 investigational sites globally, including 8 sites in India.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: Tagatose (Naturlose)	Phase II

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Spherix Incorporated:

Primary Outcome Measures:

To evaluate the effect of three low-doses of Naturlose (tagatose) in the glycemic control of patients with Type 2 Diabetes Mellitus as measured by HbA1c at the end of 6 months of therapy using the patient's own baseline HbA1c levels as control. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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:	112
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2.5 active Low dose	Drug: Tagatose (Naturlose) powder Other Name: Naturlose
Active Comparator: 5.0 mid dose 5.0 dose	Drug: Tagatose (Naturlose) powder Other Name: Naturlose
Active Comparator: 7.5 high dose high dose	Drug: Tagatose (Naturlose) powder 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 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

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

Spherix Incorporated

BioSpherix

More Information

No publications provided

Responsible Party:	Randy Brown, Chief of Operations, Spherix
ClinicalTrials.gov Identifier:	NCT00961662 History of Changes
Other Study ID Numbers:	70971-005
Study First Received:	August 17, 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 February 09, 2012