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:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

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 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 ]

Estimated Enrollment:	102
Study Start Date:	November 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

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

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

Contacts

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

Locations

United States, California
Probe Clinical Research Corp.	Recruiting
Garden Grove, California, United States, 92843
Contact: Laurel Kuhr 714-539-1909 probeclinicalresearch@gmail.com
Principal Investigator: Rizwana Mohseni
United States, Florida
Pharmax Research Clinic	Recruiting
Miami, Florida, United States, 33126
Contact: Isabel Hernandez 305-262-4321 ihernandez@pharmaxrc.com
Principal Investigator: Arsenio Columbie
United States, Georgia
Ialim Clinical Research Center	Recruiting
Decatur, Georgia, United States, 30035
Contact: Jihann Abdulaleem 678-437-7528 investigator@ialumresearch.net
Principal Investigator: Musibau Ibraheem
PMI Health Research Group	Recruiting
Atlanta, Georgia, United States, 30312
Contact: Allison Greely 404-525-5787 agreely@pmiresearch.com
Contact: Jamise McCleod 404-525-5787 jmccleod@pmiresearch.com
Principal Investigator: Philip Nowlins
United States, Texas
Juno Research, LLC	Recruiting
Houston, Texas, United States, 77036
Contact: Miguel Posada 713-779-5494 miguel_posada@junoresearch.us
Principal Investigator: Hugo Toro
India, Bihar
Diabetes Care and Research Centre	Recruiting
Patna, Bihar, India, 800 020
Contact drajaykr@yahoo.com
Principal Investigator: Ajay Kumar
India, Haryana
Bharti Research Institute of Diabetes and Endocrinology	Recruiting
Karnal, Haryana, India, 132 001
Principal Investigator: Sanjay Kalra
India, Karnataka
Bangalore Endocrinology and Diabetes Research Centre	Recruiting
Bangalore, Karnataka, India, 560 003
Contact mala_endo@rediffmail.com
Principal Investigator: Mala Dharmalingam
Belgaum Diabetes Centre	Recruiting
Belgaum, Karnataka, India, 590 001
Contact neetadeshpande@hotmail.com
Principal Investigator: Neeta Deshpande
Medisys Clinisearch India Pvt. Ltd.	Recruiting
Bangalore, Karnataka, India, 560 043
Contact dr_paramesh@hotmail.com
Principal Investigator: Parmesh Shammana
India, Madhya Pradesh
Krishna Diabetes Clinic and Educational Research Centre	Recruiting
Bhopal, Madhya Pradesh, India, 462 003
Contact shachinseema@yahoo.com
Principal Investigator: Shachin Gupta
Diabetes Thyroid Hormone Research Institute Pvt. Ltd	Recruiting
Indore, Madhya Pradesh, India, 452 001
Principal Investigator: Sunil Jain
India, Maharashtra
Research Health Institute in Diabetes Endocrinology and Metabolism	Recruiting
Mumbai, Maharashtra, India, 400 014
Contact drtusharb@gmail.com
Principal Investigator: Tushar Bandgar

Sponsors and Collaborators

Spherix Incorporated

BioSpherix

More Information

No publications provided

Responsible Party:	Spherix ( Randy Brown, Chief of Operations )
Study ID Numbers:	70971-005
Study First Received:	August 17, 2009
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00961662 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 February 08, 2010