| CTRI Number |
CTRI/2015/02/005545 [Registered on: 16/02/2015] Trial Registered Prospectively |
| Last Modified On: |
29/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to evaluate the Efficacy and Safety of Insulin Detemir against Insulin NPH along With Metformin and Diet/Exercise in Children and Adolescents having Type 2 Diabetes |
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Scientific Title of Study
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A 26-week Open Label, Randomised, 2-armed, Parallel Group, Multi-centre Trial Investigating Efficacy and Safety of Insulin Detemir Versus Insulin Neutral Protamine Hagedorn in Combination With Metformin and Diet/Exercise on Glycaemic Control in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin ± Other Oral Antidiabetic Drug(s) ± Basal Insulin |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2013-005500-33 |
EudraCT |
| NCT02131272 |
ClinicalTrials.gov |
| NN304-4093, Version. 5.0, Dated 23 April 2014 |
Protocol Number |
| U1111-1151-4056 |
UTN |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Jagannathan |
| Designation |
Director-Clinical Medical and Regulatory |
| Affiliation |
Novo Nordisk India Private Ltd |
| Address |
Plot No.32, 47 - 50 EPIP Area, Whitefield
Bangalore
KARNATAKA
560 066
India
Bangalore
KARNATAKA
560066
India |
| Phone |
918040303200 |
| Fax |
918041119026 |
| Email |
rjg@novonordisk.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Avik Kumar Gosh |
| Designation |
Head Clinical Operations |
| Affiliation |
Novo Nordisk India Private Ltd |
| Address |
Plot No.32, 47 - 50 EPIP Area, Whitefield
Bangalore
KARNATAKA
560 066
India
Bangalore
KARNATAKA
560066
India |
| Phone |
918040303200 |
| Fax |
918041119026 |
| Email |
avkg@novonordisk.com |
|
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Source of Monetary or Material Support
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|
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Primary Sponsor
|
| Name |
Novo Nordisk AS |
| Address |
c/o Plot No.32, 47 - 50,EPIP Area, Whitefield, Bangalore - 560 066 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
|
Argentina
Australia
Belgium
Brazil
Canada
China
Croatia
Denmark
France
Germany
Greece
Hungary
India
Israel
Italy
Japan
Malaysia
Mexico
Netherlands
Poland
Republic of Korea
Russian Federation
Serbia
South Africa
Spain
Taiwan
The former Yugoslav Republic of Macedonia
Turkey
United Kingdom
United States of America |
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Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek Mathew |
Department of Endocrinology |
Second Floor,
St. Johns Medical College & Hospital,
Sarjapur Road, Koramangala,
Bangalore - 560 034,
India
Bangalore
KARNATAKA |
917829082429
08025635313
vmat78@gmail.com |
| Dr B R Sivakumar |
Dr B R Ambedkar Medical College |
Department of General Medicine, Ground Floor
Kadugondanahalli (Near Tannery Road),
Bangalore 560045, Karnataka, India
Bangalore
KARNATAKA |
919900329850
08025471784
dr_shiva_kumar@yahoo.co.in |
| Dr Parag Shah |
Dr. Jivraj Mehta Health Foundation |
Bakeri Medical Research Center, Basement,
Ayojannagar,Near Shreyas crossing Road Jivraj Mehta Marg, Jivrajpark
Ahmedabad - 380007, Gujarat, India
Ahmadabad
GUJARAT |
919824042688
07926601411
paragendocrine@yahoo.com |
| Dr Aniban Majumdar |
KPC medical college |
Ground Floor, Room No. 13
26A, Gariahat Road (South) Dhakuria,
Kolkata-700 031, West Bengal, India
Kolkata
WEST BENGAL |
919830078837
03324298488
dranirbanmazumdar@gmail.com |
| Dr J Prakash |
Vanivilas Hospital-BMCRI |
Room No 72/A,second Floor Medicine New C Block,Victoria Hospital,Fort, Bangalore-560002, India
Bangalore
KARNATAKA |
919448466378
08026706260
drjprakashbmcri@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Dr. B R Ambedkar Medical College And Hospital Ethlcs Gommittee, Dr B R Sivakumar,Dr B R Ambedkar Medical College,Karnataka, India |
Submittted/Under Review |
| Ethics Committee of Bangalore Medical College and Research Institute, Dr J Prakash,Vanivilas Hospital-BMCRI,Karnataka, India |
Submittted/Under Review |
| Institutional Ethics Committee of Dr. Jivraj Mehta Smarak Health Foundation, Dr Parag Shah,Dr. Jivraj Mehta Health Foundation,Gujarat, India |
Approved |
| Institutional Ethics Committee of KPC Medical college & Hospital, Jadavpur, Dr Aniban Majumdar, KPC medical college,West Bengal, India |
Submittted/Under Review |
| Institutional Ethics Committee of St. Johns Academy of Health Sciences, Dr Vivek Mathew,St. Johns Medical College & Hospital,Karnataka, India |
Submittted/Under Review |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Diabetes Mellitus, Type 2, (1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
insulin detemir |
Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects pre-trial metformin treatment should continue unchanged during the treatment period of 26 week |
| Comparator Agent |
insulin NPH |
Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects pre-trial metformin treatment should continue unchanged during the treatment period of 26 week |
|
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Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
-Informed consent from the subject or a legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities.Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
-Male or female, above or equal to 10 years and below or equal to 17 years at the time of signing informed consent/assent
-Diagnosis of type 2 diabetes mellitus at least 3 months prior to screening
-Treated with a stable dose of metformin (1000-2000 mg/day) for at least 3 months prior to screening with or without other OAD(s) with or without basal insulin
HbA1c (glycosylated haemoglobin) above or equal to 7.0% and below or equal to 10.5% (above or equal to 53 mmol/mol and below or equal to 91 mmol/mol) at screening |
|
| ExclusionCriteria |
| Details |
Maturity onset diabetes of the young (MODY)
Fasting C-peptide at screening below 0.6 ng/mL
Impaired liver function defined as alanine aminotransferase (ALT) above or equal to 2.5 times upper normal limit
Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1c (glycosylated haemoglobin) |
Week 0, Week 26
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Change in body weight standard deviation score (SDS) |
Week 0, Week 26 |
| Proportion of subjects achieving HbA1c below 7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment |
At week 26 |
| Proportion of subjects achieving HbA1c below 7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment |
At Week 26 |
| Total number of treatment emergent nocturnal (23:00-06:59) severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes |
Weeks 0 - 26 |
| Total number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes |
Weeks 0 - 26 |
| Incidence of adverse events (AEs) |
Weeks 0 - 26 |
|
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Target Sample Size
|
Total Sample Size="358"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="4" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/02/2015 |
| Date of Study Completion (India) |
28/03/2016 |
| Date of First Enrollment (Global) |
11/06/2014 |
| Date of Study Completion (Global) |
14/06/2016 |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with metformin and diet/exercise on glycaemic control in children and adolescents with type 2 diabetes insufficiently controlled on metformin with or without other oral antidiabetic drug(s) with or without basal insulin.
|