Naturlose (D-Tagatose) Efficacy Evaluation Trial
NEET
Effects of Naturlose (Tagatose) on Glycemic Control and Safety of Naturlose Over One Year in Subjects With Type 2 Diabetes Under Diet Control and Exercise
1 other identifier
interventional
494
2 countries
46
Brief Summary
The purpose of this trial was to evaluate the effectiveness and safety of Naturlose (Tagatose) for glycemic control in people with Type 2 diabetes who were not taking other medications for the condition and who were under diet control and exercise. The study lasted approximately one year. HbA1c was monitored every 2 months after entry into the study. Safety and tolerance for tagatose were assessed every 2 months throughout the study. A total of 14 visits were made to the study site.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Apr 2007
Longer than P75 for phase_3 type-2-diabetes
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 7, 2009
CompletedFirst Posted
Study publicly available on registry
August 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
November 19, 2014
CompletedNovember 19, 2014
November 1, 2014
3.5 years
August 7, 2009
December 5, 2013
November 18, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Hemoglobin A1C Level From Baseline
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.
1 year from baseline
Study Arms (2)
Sugar Substitute Splenda
PLACEBO COMPARATOR1.5 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
EXPERIMENTAL15 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
Interventions
Eligibility Criteria
You may qualify if:
- 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 45kg/m2.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Robert Lodderlead
- University of Kentuckycollaborator
Study Sites (46)
Simon Williamson Clinc
Hueytown, Alabama, 35023, United States
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
NEA Clinical-Research Solutions
Jonesboro, Arkansas, 72404, United States
Alia Clinical Research
Huntington Park, California, 90255, United States
Atlanta Primary Care Center
Atlanta, Georgia, 30312, United States
River Birch Research Alliance
Blue Ridge, Georgia, 30513, United States
Affinity Healthcare
Arlington Heights, Illinois, 60004, United States
John Stroger Cook County Hospital
Chicago, Illinois, 60612, United States
University of Kentucky
Lexington, Kentucky, 40502, United States
Activmed Practices and Research
Haverhill, Massachusetts, 01830, United States
Nevada Alliance Against Diabetes
Las Vegas, Nevada, 89101, United States
Ocean County Clinical Research
Brick, New Jersey, 08724, United States
Cedar Clinical Research
Oradell, New Jersey, 07649, United States
Hamilton Clinical Research
Trenton, New Jersey, 08690, United States
ReSevo, LLC
Cuyahoga Falls, Ohio, 44223, United States
Capital Medical Clinic
Austin, Texas, 78705, United States
TTS Research/Hill Country Medical
Boerne, Texas, 78006, United States
Galenos Research
Dallas, Texas, 75251, United States
Century Clinical Research
Houston, Texas, 77036, United States
Cetero Research
San Antonio, Texas, 78229, United States
Optimum Clinical Research
Salt Lake City, Utah, 84102, United States
Medwin Hospital
Hyderabad, Andhra Pradesh, 500001, India
Global Hospital
Hyderabad, Andhra Pradesh, 500004, India
Diabetomics
Hyderabad, Andhra Pradesh, 500034, India
Consultant General Medicine and Diabetes
Hyderabad, Andhra Pradesh, 500035, India
Dept. of Endocrinology and Diabetes
Hyderabad, Andhra Pradesh, 500063, India
Sai Venkateshwara Multi Speciality Hospital and Critical Care Center
Hyderabad, Andhra Pradesh, 500079, India
St. John National Academy of Health Sciences
Bangalore, Karnataka, 560034, India
Padmashree Diagnostics
Bangalore, Karnataka, 560040, India
Diacon Hospital and Research Centre
Bangalore, Karnataka, 587010, India
Department of Medicine
Belagavi, Karnataka, 590010, India
Hubli Clinical Research Centre
Hubli, Karnataka, 587002, India
KMC Hospital
Mangalore, Karnataka, 575001, India
Muller Medical College
Mangalore, Karnataka, 575002, India
Department of Medicine
Mysore, Karnataka, 570004, India
Palakkad Diabetic Center
Palakkad, Kerala, 678013, India
Health and Research Centre
Trivandrum, Kerala, 695011, India
Suyash Hospital Pvt. Ltd.
Indore, Madhya Pradesh, India
Sunil's Diabetes Care n' Research Centre Pvt. Ltd.
Nagpur, Maharashtra, 440010, India
Deshmukh Clinic
Pune, Maharashtra, 411030, India
D- Clinarch
Jaipur, Rajasthan, 302016, India
Moses Diabetes and Medical Center
Chennai, Tamil Nadu, 600107, India
ACEER
Chennai, Tamil Nadu, 641020, India
Coimbatore Diabetes Foundation
Coimbatore, Tamil Nadu, 641002, India
Apollo Specialty Hospitals,KK
Madurai, Tamil Nadu, 625020, India
Trichy Diabetes Speciality Centre (P) Ltd.
Tiruchirappalli, Tamil Nadu, 620018, India
Related Publications (1)
Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.
PMID: 32449201DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Lodder
- Organization
- University of Kentucky
Study Officials
- STUDY DIRECTOR
Robert Lodder
University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 7, 2009
First Posted
August 10, 2009
Study Start
April 1, 2007
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
November 19, 2014
Results First Posted
November 19, 2014
Record last verified: 2014-11