A Clinical Study to Evaluate the Effect of Naturlose (Tagatose)

Completed · Phase 2

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00961662

Run by

Robert Lodder

People needed

161

Starts

2008-02-01

Expected to finish

2010-08-01

Last updated by the study team

2014-11-06

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 45 kg/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

• Probe Clinical Research Corp. — Garden Grove, California, United States
• Pharmax Research Clinic — Miami, Florida, United States
• PMI Health Research Group — Atlanta, Georgia, United States
• Ialim Clinical Research Center — Decatur, Georgia, United States
• Juno Research, LLC — Houston, Texas, United States
• Diabetes Care and Research Centre — Patna, Bihar, India
• Bharti Research Institute of Diabetes and Endocrinology — Karnāl, Haryana, India
• Bangalore Endocrinology and Diabetes Research Centre — Bangalore, Karnataka, India
• Medisys Clinisearch India Pvt. Ltd. — Bangalore, Karnataka, India
• Belgaum Diabetes Centre — Belagavi, Karnataka, India
• Krishna Diabetes Clinic and Educational Research Centre — Bhopal, Madhya Pradesh, India
• Diabetes Thyroid Hormone Research Institute Pvt. Ltd — Indore, Madhya Pradesh, India
• Research Health Institute in Diabetes Endocrinology and Metabolism — Mumbai, Maharashtra, India

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.