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

This study has been completed.
Sponsor:
Collaborator:
University of Kentucky
Information provided by (Responsible Party):
Robert Lodder, Spherix Incorporated
ClinicalTrials.gov Identifier:
NCT00961662
First received: August 17, 2009
Last updated: November 1, 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: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Intervention: Drug: D-Tagatose

  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
The study evaluated the data from 18 clinical study sites (11 sites in the United States and 7 sites in India)for approximately six months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Clinical laboratory testing (including comprehensive hematology, clinical chemistry, liver function tests, lipid profile, HbA1c levels and urinalysis) was performed. A urine pregnancy test was performed for female subjects of childbearing potential.

Reporting Groups
  Description
2.5 Active Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
5.0 Mid Dose 5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
7.5 High Dose high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.

Participant Flow:   Overall Study
    2.5 Active     5.0 Mid Dose     7.5 High Dose  
STARTED     57     51     53  
COMPLETED     35     32     34  
NOT COMPLETED     22     19     19  



  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
2.5 Active Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
5.0 Mid Dose 5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
7.5 High Dose high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
Total Total of all reporting groups

Baseline Measures
    2.5 Active     5.0 Mid Dose     7.5 High Dose     Total  
Number of Participants  
[units: participants]
  52     46     47     145  
Age, Customized [1]
[units: years]
Mean ± Standard Deviation
       
Age, Continuous     53.1  ± 10.2     51.1  ± 11.1     51.8  ± 12.3     52.1  ± 11.1  
Gender [2]
[units: participants]
       
Female     22     14     19     55  
Male     30     32     28     90  
[1] Baseline participants are those from the safety population.
[2] Baseline participants are from the safety population



  Outcome Measures

1.  Primary:   Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus   [ Time Frame: 6 months from baseline ]

2.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   A Decrease of ≥0.5% in HbA1c Level at Each Study Visit   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Body Weight Loss (Compared to Baseline)   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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


No publications provided


Responsible Party: Robert Lodder, Spherix Incorporated
ClinicalTrials.gov Identifier: NCT00961662     History of Changes
Other Study ID Numbers: 70971-005
Study First Received: August 17, 2009
Results First Received: December 5, 2013
Last Updated: November 1, 2014
Health Authority: United States: Food and Drug Administration