Naturlose (D-Tagatose) Efficacy Evaluation Trial (NEET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Spherix Incorporated.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
BioSpherix
Information provided by:
Spherix Incorporated
ClinicalTrials.gov Identifier:
NCT00955747
First received: August 7, 2009
Last updated: July 1, 2010
Last verified: May 2010

August 7, 2009
July 1, 2010
April 2007
August 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00955747 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Naturlose (D-Tagatose) Efficacy Evaluation Trial
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Tagatose
    powder; 15 grams three times daily; one year
    Other Name: Naturlose
  • Drug: Placebo
    Sugar Substitute
  • Placebo Comparator: Sugar substitute
    Intervention: Drug: Placebo
  • Experimental: Tagatose
    Intervention: Drug: Tagatose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
550
December 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
India,   United States
 
NCT00955747
70971-004
No
Randy Brown, Chief of Operations, Spherix
Spherix Incorporated
BioSpherix
Not Provided
Spherix Incorporated
May 2010

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