Status:
COMPLETED
Naturlose (D-Tagatose) Efficacy Evaluation Trial
Lead Sponsor:
Robert Lodder
Collaborating Sponsors:
University of Kentucky
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 conditi...
Detailed Description
This was a Phase 3, prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy, safety, and tolerability of D-tagatose (as compared to placebo). Pri...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT00955747
Start Date
April 1 2007
End Date
October 1 2010
Last Update
November 19 2014
Active Locations (46)
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1
Simon Williamson Clinc
Hueytown, Alabama, United States, 35023
2
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
3
NEA Clinical-Research Solutions
Jonesboro, Arkansas, United States, 72404
4
Alia Clinical Research
Huntington Park, California, United States, 90255