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

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ClinicalTrials.gov Identifier: NCT00955747
Recruitment Status : Completed
First Posted : August 10, 2009
Results First Posted : November 19, 2014
Last Update Posted : November 19, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Tagatose
Drug: Sugar Substitute Splenda
Enrollment 494
Recruitment Details Patients were recruited in site physicians' offices.
Pre-assignment Details Patients participated in an eight week run-in period during which diabetes education was provided and diet and exercise were stabilized.
Arm/Group Title Sugar Substitute Splenda Tagatose
Hide Arm/Group Description 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. 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
Period Title: Overall Study
Started 253 241
Completed 184 172
Not Completed 69 69
Arm/Group Title Sugar Substitute Splenda Tagatose Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 184 172 356
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 172 participants 356 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
160
  87.0%
152
  88.4%
312
  87.6%
>=65 years
24
  13.0%
20
  11.6%
44
  12.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 184 participants 172 participants 356 participants
51.6  (11.0) 51.7  (9.7) 51.7  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 172 participants 356 participants
Female
95
  51.6%
91
  52.9%
186
  52.2%
Male
89
  48.4%
81
  47.1%
170
  47.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 184 participants 172 participants 356 participants
United States 48 52 100
India 136 120 256
1.Primary Outcome
Title Change in Hemoglobin A1C Level From Baseline
Hide Description The primary efficacy variable will be the change in HbA1c level from baseline. Changes from baseline in HbA1c level at each visit will be assessed with the use of linear model(ANCOVA) to adjust for any baseline difference, as well as the stratification factor.
Time Frame 1 year from baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Calculation of the final numbers for study completion considers a standard deviation of 1.4%, a two-sided 95% confidence interval (alpha= 0.025), power of 90%, and the ability to detect a 0.5% difference in HbA1c between treatment and placebo groups.
Arm/Group Title Sugar Substitute Splenda Tagatose
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 184 172
Least Squares Mean (Standard Error)
Unit of Measure: percentage of change from baseline
0.09  (0.07) -0.11  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sugar Substitute Splenda, Tagatose
Comments All tests will be two-tailed. Unless specified otherwise, p-values less than or equal to O.050, when rounded to four decimal places,will be considered statistically significant.
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: 1.4
Estimation Comments [Not Specified]
Time Frame One year
Adverse Event Reporting Description Adverse Events will be stratified by intensity, i.e. severity categories of mild, moderate, and severe.
 
Arm/Group Title Sugar Substitute Splenda Tagatose
Hide Arm/Group Description 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. 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
All-Cause Mortality
Sugar Substitute Splenda Tagatose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sugar Substitute Splenda Tagatose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/207 (3.86%)      4/185 (2.16%)    
Cardiac disorders     
atrial fibrillation, cardiac chest pain, shortness of breath,  1  3/207 (1.45%)  3 2/185 (1.08%)  2
Gastrointestinal disorders     
Loose stools  1  1/207 (0.48%)  1 0/185 (0.00%)  0
Borborygmus  1  1/207 (0.48%)  1 0/185 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Asthenia  1  0/207 (0.00%)  0 1/185 (0.54%)  1
Worsening of Lower Backache  1  1/207 (0.48%)  1 0/185 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Carcinoma Head of Pancreas  1  1/207 (0.48%)  1 0/185 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pneumonia, lower respiratory infection  1  2/207 (0.97%)  2 0/185 (0.00%)  0
Haemoptysis  1  0/207 (0.00%)  0 1/185 (0.54%)  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 0.01%
Sugar Substitute Splenda Tagatose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   166/207 (80.19%)      163/185 (88.11%)    
Blood and lymphatic system disorders     
Dyslipidaemia  1  14/207 (6.76%)  14/185 (7.57%) 
Gastrointestinal disorders     
abdominal pain  1  35/207 (16.91%)  55/185 (29.73%) 
Abdominal Distension  1  28/207 (13.53%)  51/185 (27.57%) 
Gastrointestinal motility disorder  1  30/207 (14.49%)  45/185 (24.32%) 
Dyspepsia  1  30/207 (14.49%)  41/185 (22.16%) 
Infrequent bowel movements  1  26/207 (12.56%)  36/185 (19.46%) 
Vomiting  1  24/207 (11.59%)  34/185 (18.38%) 
Gastroesophageal reflux disease  1  22/207 (10.63%)  34/185 (18.38%) 
Faeces hard  1  24/207 (11.59%)  28/185 (15.14%) 
Epigastric discomfort  1  16/207 (7.73%)  26/185 (14.05%) 
Diarrhoea  1  51/207 (24.64%)  120/185 (64.86%) 
Flatulence  1  47/207 (22.71%)  85/185 (45.95%) 
Gastrointestinal sounds abnormal  1  38/207 (18.36%)  93/185 (50.27%) 
Frequent bowel movements  1  24/207 (11.59%)  66/185 (35.68%) 
Eructation  1  36/207 (17.39%)  51/185 (27.57%) 
Defaecation urgency  1  25/207 (12.08%)  64/185 (34.59%) 
Infections and infestations     
Pyrexia  1  18/207 (8.70%)  17/185 (9.19%) 
Upper respiratory tract infection  1  12/207 (5.80%)  9/185 (4.86%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  11/207 (5.31%)  6/185 (3.24%) 
Back pain  1  11/207 (5.31%)  4/185 (2.16%) 
Nervous system disorders     
Headache  1  23/207 (11.11%)  22/185 (11.89%) 
Renal and urinary disorders     
Urinary Tract Infection  1  12/207 (5.80%)  18/185 (9.73%) 
Respiratory, thoracic and mediastinal disorders     
Nasopharyngitis  1  12/207 (5.80%)  8/185 (4.32%) 
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: NCT00955747     History of Changes
Obsolete Identifiers: NCT00451477
Other Study ID Numbers: 70971-004
First Submitted: August 7, 2009
First Posted: August 10, 2009
Results First Submitted: December 5, 2013
Results First Posted: November 19, 2014
Last Update Posted: November 19, 2014