Status:
COMPLETED
A Clinical Study to Evaluate the Effect of Naturlose (Tagatose)
Lead Sponsor:
Robert Lodder
Collaborating Sponsors:
University of Kentucky
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is a six-month, prospective, randomized, multicenter, single- blind, controlled clinical study to evaluate the effect of three low-doses of Naturlose (Tagatose) on glycemic control and safe...
Detailed Description
Screening (Visit 1) and Run-in Period This period of the study was designed as an 8-week screening and stabilization period, during which potentially eligible subjects participated in a weight-mainta...
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 45 kg/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 :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT00961662
Start Date
February 1 2008
End Date
August 1 2010
Last Update
November 6 2014
Active Locations (13)
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1
Probe Clinical Research Corp.
Garden Grove, California, United States, 92843
2
Pharmax Research Clinic
Miami, Florida, United States, 33126
3
PMI Health Research Group
Atlanta, Georgia, United States, 30312
4
Ialim Clinical Research Center
Decatur, Georgia, United States, 30035