Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatment tagatose (naturlose)
Phase phase 2
Sponsor Spherix Incorporated
Collaborator BioSpherix
Start date November 2007
End date August 2010
Trial size 112 participants
Trial identifier NCT00961662, 70971-005

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 will be randomized in one of the 3 arms receiving 2.5, 5 or 7.5 gm of Tagatose. This trial is already on-going in the USA, and is intended to be conducted at 25 investigational sites globally, including 8 sites in India.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Low dose
tagatose (naturlose) Naturlose
powder
(Active Comparator)
5.0 dose
tagatose (naturlose) Naturlose
powder
(Active Comparator)
high dose
tagatose (naturlose) Naturlose
powder

Primary Outcomes

Measure
To evaluate the effect of three low-doses of Naturlose (tagatose) in the glycemic control of patients with Type 2 Diabetes Mellitus as measured by HbA1c at the end of 6 months of therapy using the patient's own baseline HbA1c levels as control.
time frame: 6 months

Secondary Outcomes

Measure
Effects of Naturlose (tagatose) on other glycemic control measurements such as plasma glucose concentrations and plasma lipids at each study visit
time frame: 6 months
A decrease of ≥0.5% in HbA1c level at each study visit
time frame: 6 months
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
time frame: 8 months
A decrease of Fasting Plasma Glucose (FPG) level compared with baseline level at any time point over the duration of the study
time frame: 6 months
Body weight loss (compared to baseline)
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Dose Ranging Effects of Three Low-doses of Naturlose™ (Tagatose) on Glycemic Control and Safety of Naturlose™ (Tagatose) Over Six Months in Subjects With Mild Type 2 Diabetes Mellitus Under Control With Diet and Exercise.
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by Spherix Incorporated.