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Clinical Trial Details

Trial ID: L7257
Source ID: NCT00955747
Associated Drug: Tagatose
Title: Naturlose (D-Tagatose) Efficacy Evaluation Trial
Acronym: NEET
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00955747/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Tagatose|DRUG: Sugar Substitute Splenda
Outcome Measures: Primary: Change in Hemoglobin A1C Level From Baseline, The primary efficacy variable will be the change in HbA1c level from baseline. Changes from baseline in HbA1c level at each visit will be assessed with the use of linear model(ANCOVA) to adjust for any baseline difference, as well as the stratification factor., 1 year from baseline |
Sponsor/Collaborators: Sponsor: Robert Lodder | Collaborators: University of Kentucky
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 494
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2007-04
Completion Date: 2010-10
Results First Posted: 2014-11-19
Last Update Posted: 2014-11-19
Locations: Simon Williamson Clinc, Hueytown, Alabama, 35023, United States|Medical Affiliated Research Center, Huntsville, Alabama, 35801, United States|NEA Clinical-Research Solutions, Jonesboro, Arkansas, 72404, United States|Alia Clinical Research, Huntington Park, California, 90255, United States|Atlanta Primary Care Center, Atlanta, Georgia, 30312, United States|River Birch Research Alliance, Blue Ridge, Georgia, 30513, United States|Affinity Healthcare, Arlington Heights, Illinois, 60004, United States|John Stroger Cook County Hospital, Chicago, Illinois, 60612, United States|University of Kentucky, Lexington, Kentucky, 40502, United States|Activmed Practices and Research, Haverhill, Massachusetts, 01830, United States|Nevada Alliance Against Diabetes, Las Vegas, Nevada, 89101, United States|Ocean County Clinical Research, Brick, New Jersey, 08724, United States|Cedar Clinical Research, Oradell, New Jersey, 07649, United States|Hamilton Clinical Research, Trenton, New Jersey, 08690, United States|ReSevo, LLC, Cuyahoga Falls, Ohio, 44223, United States|Capital Medical Clinic, Austin, Texas, 78705, United States|TTS Research/Hill Country Medical, Boerne, Texas, 78006, United States|Galenos Research, Dallas, Texas, 75251, United States|Century Clinical Research, Houston, Texas, 77036, United States|Cetero Research, San Antonio, Texas, 78229, United States|Optimum Clinical Research, Salt Lake City, Utah, 84102, United States|Medwin Hospital, Hyderabad, Andhra Pradesh, 500001, India|Global Hospital, Hyderabad, Andhra Pradesh, 500004, India|Diabetomics, Hyderabad, Andhra Pradesh, 500034, India|Consultant General Medicine and Diabetes, Hyderabad, Andhra Pradesh, 500035, India|Dept. of Endocrinology and Diabetes, Hyderabad, Andhra Pradesh, 500063, India|Sai Venkateshwara Multi Speciality Hospital and Critical Care Center, Hyderabad, Andhra Pradesh, 500079, India|St. John National Academy of Health Sciences, Bangalore, Karnataka, 560034, India|Padmashree Diagnostics, Bangalore, Karnataka, 560040, India|Diacon Hospital and Research Centre, Bangalore, Karnataka, 587010, India|Department of Medicine, Belgaum, Karnataka, 590010, India|Hubli Clinical Research Centre, Hubli, Karnataka, 587002, India|KMC Hospital, Mangalore, Karnataka, 575001, India|Muller Medical College, Mangalore, Karnataka, 575002, India|Department of Medicine, Mysore, Karnataka, 570004, India|Palakkad Diabetic Center, Palakkad, Kerala, 678013, India|Health and Research Centre, Trivandrum, Kerala, 695011, India|Suyash Hospital Pvt. Ltd., Indore, Madhya Pradesh, India|Sunil's Diabetes Care n' Research Centre Pvt. Ltd., Nagpur, Maharashtra, 440010, India|Deshmukh Clinic, Pune, Maharashtra, 411030, India|D- Clinarch, Jaipur, Rājasthān, 302016, India|Moses Diabetes and Medical Center, Chennai, Tamil Nadu, 600107, India|ACEER, Chennai, Tamil Nadu, 641020, India|Coimbatore Diabetes Foundation, Coimbatore, Tamil Nadu, 641002, India|Apollo Specialty Hospitals,KK, Madurai, Tamil Nadu, 625020, India|Trichy Diabetes Speciality Centre (P) Ltd., Tiruchirapalli, Tamil Nadu, 620018, India
URL: https://clinicaltrials.gov/show/NCT00955747

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