Naturlose (D-Tagatose) Efficacy Evaluation Trial

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robert Lodder
• Collaborator: University of Kentucky
• Treatments: Tagatose

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.