Phase 3
N=494
Naturlose (D-Tagatose) Efficacy Evaluation Trial
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00955747 ↗Enrolled (actual)
494
Serious AEs
3.1%
Results posted
Nov 2014
Primary outcome: Primary: Change in Hemoglobin A1C Level From Baseline — 0.09; -0.11 percentage of change from baseline — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tagatose (Drug); Sugar Substitute Splenda (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Robert Lodder
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin A1C Level From Baseline |
0.09; -0.11 | <0.05 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00955747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.