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

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ClinicalTrials.gov Identifier: NCT00961662
Recruitment Status : Completed
First Posted : August 19, 2009
Results First Posted : November 6, 2014
Last Update Posted : November 6, 2014
Sponsor:
Collaborator:
University of Kentucky
Information provided by (Responsible Party):
Robert Lodder, Spherix Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Intervention Drug: D-Tagatose
Enrollment 161
Recruitment Details 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 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.
Arm/Group Title 2.5 Active 5.0 Mid Dose 7.5 High Dose
Hide Arm/Group Description Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose. 5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose. high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
Period Title: Overall Study
Started 57 51 53
Completed 35 32 34
Not Completed 22 19 19
Arm/Group Title 2.5 Active 5.0 Mid Dose 7.5 High Dose Total
Hide Arm/Group Description Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose. 5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose. high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose. Total of all reporting groups
Overall Number of Baseline Participants 52 46 47 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Age, Continuous Number Analyzed 52 participants 46 participants 47 participants 145 participants
53.1  (10.2) 51.1  (11.1) 51.8  (12.3) 52.1  (11.1)
[1]
Measure Description: Baseline participants are those from the safety population.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 46 participants 47 participants 145 participants
Female
22
  42.3%
14
  30.4%
19
  40.4%
55
  37.9%
Male
30
  57.7%
32
  69.6%
28
  59.6%
90
  62.1%
[1]
Measure Description: Baseline participants are from the safety population
1.Primary Outcome
Title Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus
Hide Description The primary efficacy parameter was a dichotomous variable: the treatment success as measured by a reduction from baseline HbA1c by at least 0.5 units after six months of treatment (i.e.,0.5% reduction in HbA1c after six months of treatment).
Time Frame 6 months from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title 2.5 Active 5.0 Mid Dose 7.5 High Dose
Hide Arm/Group Description:
Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
Overall Number of Participants Analyzed 52 46 47
Measure Type: Number
Unit of Measure: participants
10 7 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 2.5 Active, 5.0 Mid Dose, 7.5 High Dose
Comments The HbA1c percent change at each study visit was calculated and then categorized as a binary response (i.e., responders and non-responders) for each subject based on the breakpoint to be used in the endpoint. Inferential statistics were prepared to compare the differences across the three treatments a using logistic regression model with the dose group and the HbA1c stratum included in the mode
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.5
Parameter Dispersion
Type: Standard Deviation
Value: 1.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Effects of Naturlose (Tagatose) on Other Glycemic Control Measurements Such as Plasma Glucose Concentrations and Plasma Lipids at Each Study Visit
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title A Decrease of ≥0.5% in HbA1c Level at Each Study Visit
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 8 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title A Decrease of Fasting Plasma Glucose (FPG) Level Compared With Baseline Level at Any Time Point Over the Duration of the Study
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Body Weight Loss (Compared to Baseline)
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
Time Frame 6 months
Adverse Event Reporting Description A gastrointestinal Symptom Rating Scale was used. Number of Participants at Risk was based upon the Safety population. Adverse Events were analyzed with regard to the affected organ system only.
 
Arm/Group Title 2.5 Active 5.0 Mid Dose 7.5 High Dose
Hide Arm/Group Description Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose. 5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose. high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
All-Cause Mortality
2.5 Active 5.0 Mid Dose 7.5 High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
2.5 Active 5.0 Mid Dose 7.5 High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/52 (0.00%)      0/46 (0.00%)      2/47 (4.26%)    
Cardiac disorders       
Acute Coronary Syndrome  1  0/52 (0.00%)  0 0/46 (0.00%)  0 1/47 (2.13%)  1
Nervous system disorders       
Ataxia with Diabetic Neuropathy  1  0/52 (0.00%)  0 0/46 (0.00%)  0 1/47 (2.13%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
2.5 Active 5.0 Mid Dose 7.5 High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/52 (57.69%)      24/46 (52.17%)      27/47 (57.45%)    
Gastrointestinal disorders       
Gastrointestinal disorders  1  23/52 (44.23%)  16/46 (34.78%)  17/47 (36.17%) 
General disorders       
General disorders and administration site conditions  1  5/52 (9.62%)  5/46 (10.87%)  3/47 (6.38%) 
Infections and infestations       
Infections and infestations  1  10/52 (19.23%)  7/46 (15.22%)  8/47 (17.02%) 
Metabolism and nutrition disorders       
Metabolism and Nutrition disorders  1  3/52 (5.77%)  4/46 (8.70%)  5/47 (10.64%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal and connective tissue disorders  1  5/52 (9.62%)  3/46 (6.52%)  4/47 (8.51%) 
Nervous system disorders       
Nervous system disorder  1  5/52 (9.62%)  3/46 (6.52%)  3/47 (6.38%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory disorders  1  1/52 (1.92%)  4/46 (8.70%)  0/47 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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
Responsible Party: Robert Lodder, Spherix Incorporated
ClinicalTrials.gov Identifier: NCT00961662     History of Changes
Other Study ID Numbers: 70971-005
First Submitted: August 17, 2009
First Posted: August 19, 2009
Results First Submitted: December 5, 2013
Results First Posted: November 6, 2014
Last Update Posted: November 6, 2014