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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.
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