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

This study has been completed.
Sponsor:
Collaborator:
University of Kentucky
Information provided by (Responsible Party):
Robert Lodder, Spherix Incorporated
ClinicalTrials.gov Identifier:
NCT00955747
First received: August 7, 2009
Last updated: November 18, 2014
Last verified: November 2014
Results First Received: December 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Tagatose
Drug: Sugar Substitute Splenda

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited in site physicians' offices.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients participated in an eight week run-in period during which diabetes education was provided and diet and exercise were stabilized.

Reporting Groups
  Description
Sugar Substitute Splenda 1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
Tagatose 15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment

Participant Flow:   Overall Study
    Sugar Substitute Splenda   Tagatose
STARTED   253   241 
COMPLETED   184   172 
NOT COMPLETED   69   69 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugar Substitute Splenda 1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
Tagatose 15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
Total Total of all reporting groups

Baseline Measures
   Sugar Substitute Splenda   Tagatose   Total 
Overall Participants Analyzed 
[Units: Participants]
 184   172   356 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   160   152   312 
>=65 years   24   20   44 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.6  (11.0)   51.7  (9.7)   51.7  (10.4) 
Gender 
[Units: Participants]
     
Female   95   91   186 
Male   89   81   170 
Region of Enrollment 
[Units: Participants]
     
United States   48   52   100 
India   136   120   256 


  Outcome Measures

1.  Primary:   Change in Hemoglobin A1C Level From Baseline   [ Time Frame: 1 year from baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert Lodder
Organization: University of Kentucky
phone: 859-955-0845
e-mail: lodder@uky.edu



Responsible Party: Robert Lodder, Spherix Incorporated
ClinicalTrials.gov Identifier: NCT00955747     History of Changes
Obsolete Identifiers: NCT00451477
Other Study ID Numbers: 70971-004
Study First Received: August 7, 2009
Results First Received: December 5, 2013
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration