| CTRI Number |
CTRI/2009/091/000912 [Registered on: 18/05/2010] |
| Last Modified On: |
30/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
"A Phase 3b trial, in type 1 diabetes mellitus, on children who are at least 1 year old to less than 6 years and are given either Lantus (insulin glargine) or Neutral Protamine Hagedorn (NPH) insulin as the medication?.
|
Scientific Title of Study
Modification(s)
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A 24-week, Randomized, Open-label, Parallel Group Multinational Comparison of Lantus® (Insulin Glargine) Given in the Morning as Once-a-day Basal Insulin Versus NPH Insulin, in Children With Type 1 Diabetes Mellitus Aged at Least 1 Year to Less Than 6 Years
|
| Trial Acronym |
PRESCHOOL |
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| EFC 11202 |
Protocol Number |
| NCT00993473 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Ms Gayatri Jaiswal |
| Designation |
Sr Clinical Project Leader |
| Affiliation |
Sanofi Synthelabo India Limited |
| Address |
Sanofi Synthelabo (India) Limited, Sir Mathuradas Vasanji Road, Chakala, Andheri East, Mumbai
Mumbai
MAHARASHTRA
400-093
India |
| Phone |
02228278046 |
| Fax |
|
| Email |
gayatri.jaiswal@sanofi.com |
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Details of Contact Person
Public Query
Modification(s)
|
| Name |
Ms Gayatri Jaiswal |
| Designation |
Sr Clinical Project Leader |
| Affiliation |
Sanofi Synthelabo India Limited |
| Address |
Sanofi Synthelabo (India) Limited, Sir Mathuradas Vasanji Road, Andheri East, Mumbai
Mumbai
MAHARASHTRA
400-093
India |
| Phone |
02228278046 |
| Fax |
|
| Email |
gayatri.jaiswal@sanofi.com |
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Source of Monetary or Material Support
Modification(s)
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| Sanofi Synthelabo. 54/A, Sir Mathuradas Vasanji Road Andheri(E), Mumbai-400093, India |
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Primary Sponsor
Modification(s)
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| Name |
Sanofi Synthelabo India limited |
| Address |
54/A, Sir Mathuradas Vasanji Road Andheri(E), Mumbai-400093, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
Modification(s)
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|
Countries of Recruitment
Modification(s)
|
India
Australia
Brazil
Chile
Czech Republic
Germany
Hungary
Mexico
Peru
Poland
Romania
Russian Federation
South Africa
Spain
Turkey
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prasanna Kumar |
Bangalore Diabetes Hospital, #16/M, Miller Tank Bed Area, Thimmaiah Road, Vasanthnagar |
,-560043
Bangalore
KARNATAKA |
09845156811
dr.kmpk@gmail.com |
| Dr Sanjay Kalra |
Bangalore Endocrinology & Diabetes Research Center. |
Bharti Research Institute of Diabetes & Endocrinology (B.R.I.D.E.),Wazir Chand Colony, Kunjpura road,Karnal 132001
Karnal
HARYANA |
9215848555
01842267885
amiasianboy@yahoo.com |
| Dr Mala Dharmalingam |
Bangalore Endocrinology & Diabetes Research Center. |
,-560003.
Bangalore
KARNATAKA |
09845208163
mala_endo@rediffmail.com |
| Dr. Sunil Jain |
Diabetes Thyroid Hormone Research Institute Pvt LtdResearch Institute Pvt Ltd, 11/5, New Palasia |
,-452001
Indore
MADHYA PRADESH |
09826023182
sunilmjain@gmail.com |
| Dr Paramesh Shamanna |
Medisys Clinisearch India Pvt. Ltd |
,-560043
Bangalore
KARNATAKA |
09845010610
dr_paramesh@hotmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Bangalore Diabetes Hospital Ethics Committee, Bangalore Diabetes Hospital,#16M Miller Tank Bed Area, Thimmaiah Road, Vasanthnagar, Bangalore- 560052 |
Submittted/Under Review |
| Bangalore Endocrinology and Diabetes Research Centre Ethics Committee on Human Research 33/1, 1 Floor, Margosa Main Road, Between 12th and 13th Cross , Malleshwaram, |
Approved |
| CLINICOM - "Bhooma", No.7, 17 A Cross, Malleshwaram West, Bangalore 560055 |
Approved |
| Ethics Committee of Diabetes Thyroid Hormone Research Institute Pvt Ltd, 11/5, New Palasia (After Chhappan Dukan Triangle, On Right Side), Indore -452001(MP), India |
Approved |
| Medisys Clinisearch Ethical Review Board. |
Submittted/Under Review |
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Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
In patients with Type 1 diabetes mellitus insufficiently aged between 1 to 6 years
, (1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications, |
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Intervention / Comparator Agent
Modification(s)
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| Type |
Name |
Details |
| Intervention |
Insulin glargine |
Insulin glargine administration will occur in the morning, after waking up and before breakfast, at roughly the same time each day for a given patient: NPH insulin injection times (once or twice daily) will be at the discretion of the Investigator. |
| Comparator Agent |
INSULIN GLARGINE (HOE901) |
100 U/mL
Solostar® pen devices
containing 300 U, and in 10 mL vials (each containing 1000 U) |
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Inclusion Criteria
Modification(s)
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study
|
|
| ExclusionCriteria |
| Details |
Diagnosis of type 1 diabetes for less than one year
HbA1c at screening >12% or <6%
Diabetes other than type 1 diabetes.
Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person)
Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit
Patients treated with insulin pump therapy during the two months prior to screening
History of primary seizure disorder
History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit
Hypoglycemia unawareness, as determined by the Investigator
Serum creatinine > 2.0mg/dL at screening
Serum ALT or AST greater than 3x upper limit of normal for the patient's age and gender, at screening
Hemoglobin < 10g/dL, or platelet count less than 100,000/cu mm, at screening
Treatment with any anti-hyperglycemic oral agent at any time since the diagnosis of diabetes
Treatment with any non-insulin antihyperglycemic medication (eg, Symlin®) for the 3 months prior to screening
Treatment with systemic glucocorticoids within the month prior to screening
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Method of Generating Random Sequence
Modification(s)
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Computer generated randomization |
Method of Concealment
Modification(s)
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Centralized |
Blinding/Masking
Modification(s)
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Open Label |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
Event rate of "all hypoglycemia" during treatment with study drugs, which consists of: CGM glucose 70 mg/dL (3.9mM) , Self-Monitored Blood Glucose values 70 mg/dL (3.9mM), symptomatic hypoglycemia episodes
|
6 months |
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Secondary Outcome
Modification(s)
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| Outcome |
TimePoints |
| vent Rate of Symptomatic Hypoglycemia (Individual Component of Primary Endpoint) Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year) |
6 months |
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Target Sample Size
Modification(s)
|
Total Sample Size="120"
Sample Size from India="13"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
28/07/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/10/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Clinical Study Report |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
This is a global study being conducted in 19 countries and 100 sites across the globe and 120 is the target size globally. From India, at least 1 patient and max of 3 patients from each of the 5 participating sites are proposed to be enrolled. Therefore, minimum of 5 and maximum of 15 patients will be enrolled from India in total. The Global recruitment is started and so far 7 patients are randimized. 120 patients will be enrolled into the study, in order to have at least 70 evaluable patients completing 24 weeks of treatment. Global date of enrollment, Globally 1st patient was screened on 15/October/2009 and enrolled on 15/Nov/09 in the U.S. We have selected 5 sites in India. We will be recruiting 5-15 patients from India. The anticipated date of enrollment from India will be 25th- June 2010. We have received DCGI approval dated 13 May 2010. |