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View Clinical Trial (Medical Research Study)
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A Clinical Study to Evaluate the Effect of Naturlose (Tagatose) - NCT00961662-30312 (Clinical Trial 306384)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy306384.aspx
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| City: |
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Atlanta |
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State:
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GA |
| Zip Code: |
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30312 |
| Conditions: |
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Type 2 Diabetes |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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. |
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| Study is available at: |
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PMI Health Research Group
Atlanta, GA 30312
United States
Primary Contact:
Allison Greely
Email: agreely@pmiresearch.com
Phone: 404-525-5787
Secondary Contact:
Randy Brown
Email: rbrown@spherix.com
Phone: 301.957.4275 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 17, 2009 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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