Naturlose (D-Tagatose) Efficacy Evaluation Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

August 7, 2009

Last Updated Date

August 11, 2009

Start Date ^ICMJE

April 2007

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate a placebo-subtracted treatment effect of tagatose in glycemic control determined by a statistically significant decrease in hemoglobin A1c (HbA1c) levels. [ Time Frame: One Year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00955747 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Naturlose (D-Tagatose) Efficacy Evaluation Trial

Official Title ^ICMJE

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

Brief Summary

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

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: Tagatose
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

550

Estimated Completion Date

April 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States, India

Administrative Information

NCT ID ^ICMJE

NCT00955747

Responsible Party

Randy Brown, Chief of Operations, Spherix

Study ID Numbers ^ICMJE

70971-004

Study Sponsor ^ICMJE

Spherix Incorporated

Collaborators ^ICMJE

BioSpherix

Investigators ^ICMJE

Information Provided By

Spherix Incorporated

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP