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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Spherix Incorporated.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
BioSpherix
Information provided by:
Spherix Incorporated
ClinicalTrials.gov Identifier:
NCT00961662
First received: August 17, 2009
Last updated: July 1, 2010
Last verified: June 2010

August 17, 2009
July 1, 2010
November 2007
August 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00961662 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Clinical Study to Evaluate the Effect of Naturlose (Tagatose)
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Type 2 Diabetes
Drug: Tagatose (Naturlose)
powder
Other Name: Naturlose
  • Experimental: 2.5 active
    Low dose
    Intervention: Drug: Tagatose (Naturlose)
  • Active Comparator: 5.0 mid dose
    5.0 dose
    Intervention: Drug: Tagatose (Naturlose)
  • Active Comparator: 7.5 high dose
    high dose
    Intervention: Drug: Tagatose (Naturlose)
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
112
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 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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
India,   United States
 
NCT00961662
70971-005
No
Randy Brown, Chief of Operations, Spherix
Spherix Incorporated
BioSpherix
Not Provided
Spherix Incorporated
June 2010

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