Naturlose (D-Tagatose) Efficacy Evaluation Trial

Completed · Phase 3

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00955747

Run by

Robert Lodder

People needed

494

Starts

2007-04-01

Expected to finish

2010-10-01

Last updated by the study team

2014-11-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Simon Williamson Clinc — Hueytown, Alabama, United States
• Medical Affiliated Research Center — Huntsville, Alabama, United States
• NEA Clinical-Research Solutions — Jonesboro, Arkansas, United States
• Alia Clinical Research — Huntington Park, California, United States
• Atlanta Primary Care Center — Atlanta, Georgia, United States
• River Birch Research Alliance — Blue Ridge, Georgia, United States
• Affinity Healthcare — Arlington Heights, Illinois, United States
• John Stroger Cook County Hospital — Chicago, Illinois, United States
• University of Kentucky — Lexington, Kentucky, United States
• Activmed Practices and Research — Haverhill, Massachusetts, United States
• Nevada Alliance Against Diabetes — Las Vegas, Nevada, United States
• Ocean County Clinical Research — Brick, New Jersey, United States
• Cedar Clinical Research — Oradell, New Jersey, United States
• Hamilton Clinical Research — Trenton, New Jersey, United States
• ReSevo, LLC — Cuyahoga Falls, Ohio, United States
• Capital Medical Clinic — Austin, Texas, United States
• TTS Research/Hill Country Medical — Boerne, Texas, United States
• Galenos Research — Dallas, Texas, United States
• Century Clinical Research — Houston, Texas, United States
• Cetero Research — San Antonio, Texas, United States
• Optimum Clinical Research — Salt Lake City, Utah, United States
• Medwin Hospital — Hyderabad, Andhra Pradesh, India
• Global Hospital — Hyderabad, Andhra Pradesh, India
• Diabetomics — Hyderabad, Andhra Pradesh, India
• Consultant General Medicine and Diabetes — Hyderabad, Andhra Pradesh, India

Full record on ClinicalTrials.gov

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