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REFCTRI/2009/000632 CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Fri, 28 Oct 2016 21:03:43 GMT) CTRI Number CTRI/2009/091/000632 [Registered on: 13/08/2009] - Last Modified On 19/09/2014 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Multiple Arm Trial Public Title of Study A clinical trial to study the effects of Naturlose (Tagatose) in patients with mild type 2 Diabetes Mellitus under control with Diet and Exercise over a period of 6 months Scientific Title of Study 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. Secondary IDs if Any Secondary ID Identifier 70971-005 Protocol Number Details of Principal Investigator or overall Name Trial Coordinator Designation (multi-center study) Affiliation Details of Principal Investigator Address Phone Fax Email Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details Contact Person (Scientific Query) Name Partha Chatterjee Designation Head - Clinical Research and CTSM Affiliation SIRO Clinpharm Pvt. Ltd. Address SIRO Clinpharm Pvt. Ltd. DIL Complex, II Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road Thane MAHARASHTRA 400 610 India Phone 02225848000 Fax 02225848275 Email [email protected] Details Contact Person (Public Query) Name Partha Chatterjee Designation Head - Clinical Research and CTSM Affiliation SIRO Clinpharm Pvt. Ltd. Address SIRO Clinpharm Pvt. Ltd. DIL Complex, II Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road Thane MAHARASHTRA 400 610 India Phone 02225848000 page 1 / 6 REFCTRI/2009/000632 CTRI Website URL - http://ctri.nic.in Source of Monetary or Material Support Fax 022-25848275 Email [email protected] Source of Monetary or Material Support > Spherix Inc. BioSpherix Division, 6430 Rockledge Drive Suite 503, Bethesda, Maryland, 20817, USA Primary Sponsor Primary Sponsor Details Name Spherix Inc Address BioSpherix Division, 6430 Rockledge Drive Suite 503, Bethesda, Maryland, 20817, USA Type of Sponsor Pharmaceutical industry-Global Details of Secondary Sponsor Name Countries of Recruitment List of Countries Address NIL India United States of America Sites of Study Name of Principal Investigator Name of Site Site Address Phone/Fax/Email Dr Mala Dharmalingam Bangalore Endocrinology and Diabetes Research Centre Diabetes Research 08065965758 Centre, No.33/1, 1st Floor, Margosa Road, mala_endo@rediffmail. Between 12th and 13th com cross, Malleshwaram, Bangalore- 560003. Bangalore KARNATAKA Dr. Neeta Deshpande Belgaum Diabetes Centre ,-590 001 Belgaum KARNATAKA Bharti Research Institute of Diabetes and Endocrinology ,-132 001 Karnal HARYANA Diabetes Care and Research Centre GC & B Near Overbridge, Kankerbagh, Patna 800020. Bihar, India. Patna BIHAR Dr. Sanjay Kalra Dr Ajay Kumar neetadeshpande@hotm ail.com [email protected] 06122350434 [email protected] Dr Sunil Jain Diabetes Thyroid Hormone Research Institute Pvt. Ltd. 11/5, New Palasia Opp 07312543622 Chhappan Dukan Triangle, Indore [email protected] 452001. Madhya Pradesh, India. Indore MADHYA PRADESH Dr. Sujit Chandratreya Endocare Clinic ,-422013 Nashik MAHARASHTRA Dr Shachin Gupta [email protected] m Krishna Diabetes Clinic 8/2 Sanjay Complex, 0755248288 and Educational South T.T. Nagar, Near Research Centre Mata Mandir, Bhopal - shachinseema@yahoo. 462003. Madhya com Pradesh, India. Bhopal MADHYA PRADESH page 2 / 6 REFCTRI/2009/000632 CTRI Website URL - http://ctri.nic.in Dr. Parmesh Shammana Medisys Clinisearch India Pvt. Ltd. ,-560 043 Bangalore KARNATAKA Dr. Tushar Bandgar Research Health Institute in Diabetes ,-400 014 Mumbai MAHARASHTRA Sunil's Diabetes care and Research Centre ,-440010 Nagpur MAHARASHTRA Name of Committee Approval Status Date of Approval Is Independent Ethics Committee? Bharti Research Institute of Diabetes & Endocrinology Institutional Ethics Committee Approved 22/04/2009 No Bio-Compatible Ethics Committee Approved 21/10/2009 Yes CLINICOM, Bangalore (For Dr. Neeta Deshpandes site) Approved 27/08/2009 Yes CLINICOM, Bangalore (For Dr. Tushar Bandgars site) Approved 27/08/2009 Yes Ethics Committee Bangalore Endocrinology & Diabetes Research Centre, Bangalore Approved 22/04/2009 No Ethics Committee Diabetes Care & Research Centre, Patna Approved 25/04/2009 No Ethics Committee of Diabetes Care and Research centre Approved 16/10/2009 No Ethics Committee of Approved Diabetes Thyroid Hormone Research Institute Pvt. Ltd, Indore 12/04/2009 No Independent Ethics Committee of Krishna Diabetes Clinic & Educational Research Center, Bhopal Approved 07/04/2009 Yes Medisys Clinisearch Ethical Review Board, Bangalore Approved 24/04/2009 No Dr. Sunil Gupta Details of Ethics Committee dr_paramesh@hotmail. com [email protected] sweetysunil125@yahoo .com Regulatory Clearance Status from DCGI Status Date Approved/Obtained 06/08/2009 Health Condition / Problems Studied Health Type Condition Patients Type 2 Diabetes Mellitus Intervention / Comparator Agent Type Name Details Intervention D-Tagatose 2.5/5.0/7.5 g TID for 6 months page 3 / 6 REFCTRI/2009/000632 CTRI Website URL - http://ctri.nic.in Comparator Agent NIL Inclusion Criteria NIL Inclusion Criteria Age From 18.00 Year(s) Age To 75.00 Year(s) Gender Both Details 1.Diagnosis of Type 2 Diabetes Mellitus in accordance to WHO criteria. 2.Gender: male and female patients. 3.Age: between 18 and 75 years of age. 4.Currently are not receiving any anti-diabetic medication within 3 months of the screening visit. Patients should be treated with diet and exercise only. 5.Have a HbA1c level at screening and baseline between 6.6% and 9.0%. Changes in HbA1c between screening and randomization visits cannot exceed 1.0% (if they do, a redraw will be done and if confirmed, the patient will have to be terminated from the study). 6.Fasting blood glucose concentration of less than 240 mg/dl (13.3 mmol/l). 7.BMI of less than or equal to 25 and greater than or equal to 45 kg/m2. 8.Weight stable (10%) for 3 months before entry to study. 9.Are capable, as determined by the investigator, to the following: a. complete the study diary b. are receptive to diabetes education, including continuing their pre-study diet and activity levels c. are able to comply with the required study visits 10.Have given written informed consent to participate in this study in accordance to local regulations before any trial related activities (other than initial screening) are carried out. Exclusion Criteria Exclusion Criteria Details 1.Have a current or recent history (within the prior 3 months) of treatment with any oral or injectable anti-diabetic treatment including sulfonylurea drugs (glimepiride glyburide, chlorpropamide, acetohexamide, glipizide, tolbutamide, tolazamide), thiazolidinediones (pioglitazone or roziglitazone), biguanides (metformin), alpha-glucosidase inhibitors (acarbose and miglitol), meglitinides (repaglinide), D-phenylalanine derivatives (nateglinide), dipeptidyl peptidase 4 (DPP-4) inhibitors (sitagliptin), insulin (lente, NPH, premixed, regular or ultralente), insulin-analogs (aspart, insulin glargine or lispro), exenetide, pramlintide or any other anti-diabetic medication. 2.Have had 1 or more episodes of severe hypoglycemia, as defined in the Abbreviations and Definitions section of this protocol, within 6 months prior to entry into the study, or is currently diagnosed as having hypoglycemia unawareness. 3.Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the last 6 months. 4.Are pregnant or plan to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable. 5.Are women currently breastfeeding 6.Are currently or have recently (within the last 3 months) used any weight loss drugs for at least 14 consecutive days. 7.Have experienced any significant weight loss (less than or equal to 10% of their body weight) within the prior 3 months. 8.Suffer from any severe complications of Diabetes including diabetic retinopathy, neuropathy or nephropathy. 9.Currently suffer or have suffered within the last 6 months of a page 4 / 6 REFCTRI/2009/000632 CTRI Website URL - http://ctri.nic.in serious cardiac disease including decompensated congestive heart failure (NYHA class III or IV); unstable angina pectoris or a myocardial infarction. 10.Have a history of end stage renal disease (ESRD) or renal transplantation or are currently receiving renal dialysis. 11.Evidence of impaired renal function (serum creatinine 132 mM, or 1.5 mg/dL). 12.Have clinical signs or symptoms or laboratory evidence of severe liver disease (ALT and/or AST two times the upper limit of the reference range, as defined by the central reference laboratory) or have an albumin value above or below the normal reference range as defined by the central reference laboratory. 13.Presence of uncontrolled hypertension (systolic pressure 180 mm Hg and/or diastolic pressure 100 mm Hg) on two or more separate readings. 14.Documented organic gastrointestinal disease requiring treatment with medications likely to alter gut motility or absorption. 15.History of organ transplantation and are currently receiving treatment with immunosuppressive agents. 16.Patients diagnosed within the last five years of any malignancy (except for basal cell or squamous cell carcinoma of the skin) not yet treated or currently under treatment. 17.Have any of the following concomitant diseases: congenital or acquired immunodeficiency, clinically significant hematological, oncologic, renal, cardiac, hepatic, gastrointestinal or other serious disease, which in the judgment of the investigator could interfere with participation or retention into the study. 18.Have received a blood transfusion or severe blood loss within the last three months prior to enrollment or to suffer from any form of anemia, hemolytic anemia, hemoglobinopathy, sickle-cell disease or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c. 19.Have recently (within the last three months) received systemic treatment with any of the following hormones for at least 14 consecutive days: corticosteroids (excluding topical, intra-articular, intra-ocular or inhaled preparations), thyroid hormone supplements, human growth hormone or any other hormone (except estrogen replacement therapy or oral contraceptives). 20.Have a history of current or recent (within the last three months) consecutive (14 days or more) use of any immunosuppressive medication 21.Have a current or past history or are suspected of alcohol or any other substance abuse. 22.Receiving any investigational drug within 30 days of the baseline visit. 23.Patients who for whatever other reason are deemed by the investigator inadequate for participation in this trial (e.g., patients with incapacitating mental illness, severe asthma, or regular consumers of the foods or food additives similar to the testing material). 24.Have previously completed or withdrawn from this study after having signed the informed consent document (ICD) 25.Have participated in any investigational clinical trial or having received treatment with a drug that has not received regulatory approval by the FDA for any indication in the United States within the previous 30 days to enrollment into the study. Method of Generating Computer generated randomization Random Sequence Method of Concealment Centralized page 5 / 6 REFCTRI/2009/000632 CTRI Website URL - http://ctri.nic.in Blinding/Masking Participant Blinded Primary Outcome Outcome 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 patients own baseline HbA1c levels as control. Secondary Outcome Timepoints 6 months Outcome A decrease of less than or equal to 0.5% in HbA1c level at each study visit Timepoints 6 months Effects of Naturlose (tagatose) on other glycemic 6 months control measurements such as plasma glucose concentrations and plasma lipids at each study visit A decrease of less than or eual to 1% in HbA1c 8 months level in any of the Naturlose (tagatose) treatment groups at any time point over the duration of the study A decrease of Fasting Plasma Glucose (FPG) level compared with baseline level at any time point over the duration of the study 6 months Body weight loss (compared to baseline) 6 months Target Sample Size Total Sample Size=120 Sample Size from India=102 Phase of Trial Phase 2 Date of First Enrollment (India) 28/10/2009 Date of First Enrollment (Global) 15/02/2008 Estimated Duration of Years=0 Trial Months=8 Days=0 Recruitment Status of Completed Trial (Global) Recruitment Status of Completed Trial (India) Publication Details NA Brief 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 USA, and is intended to conduct at 25 investigational sites globally, including 8 sites in India. Target Sample size for India - 102 patients to be enrolled. The first patient will be enrolled by 14th August 2009. page 6 / 6 Powered by TCPDF (www.tcpdf.org)