Phase 2
Completed N=161
A Clinical Study to Evaluate the Effect of Naturlose (Tagatose)
Source: ClinicalTrials.gov NCT00961662 ↗Enrolled (actual)
161
Serious AEs
1.4%
Results posted
Nov 2014
Primary outcomePrimary: Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus — 10; 7; 12 participants — p=<0.05
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 safety in subjects with Type 2 diabetes under diet control and exercise. The subjects were randomized in one of the 3 arms receiving 2.5, 5 or 7.5 gm of Tagatose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline HbA1c After Six Months of Treatment in Patients With Type 2 Diabetes Mellitus |
10; 7; 12 | <0.05 sig |
| SECONDARY Effects of Naturlose (Tagatose) on Other Glycemic Control Measurements Such as Plasma Glucose Concentrations and Plasma Lipids at Each Study Visit |
— | — |
| SECONDARY A Decrease of ≥0.5% in HbA1c Level at Each Study Visit |
— | — |
| SECONDARY A Decrease of ≥1% in HbA1c Level in Any of the Naturlose (Tagatose) Treatment Groups at Any Time Point Over the Duration of the Study |
— | — |
| SECONDARY A Decrease of Fasting Plasma Glucose (FPG) Level Compared With Baseline Level at Any Time Point Over the Duration of the Study |
— | — |
| SECONDARY Body Weight Loss (Compared to Baseline) |
— | — |
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 45 kg/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 (NCT00961662). 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. Informational only — not medical advice.