| CTRI Number |
CTRI/2023/10/059275 [Registered on: 30/10/2023] Trial Registered Prospectively |
| Last Modified On: |
26/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Glargine once versus twice daily |
|
Scientific Title of Study
|
Comparative efficacy of once daily versus twice daily insulin glargine in children with type 1 diabetes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surbhi Bharti |
| Designation |
junior resident |
| Affiliation |
government medical college and hospital chandigarh |
| Address |
Department of pediatrics government medical college and hospital chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7876161007 |
| Fax |
|
| Email |
5surbhib@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal Guglani |
| Designation |
Head of the Department |
| Affiliation |
government medical college and hospital chandigarh |
| Address |
Department of Pediatrics, government medical college and hospital chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7876161007 |
| Fax |
|
| Email |
vishal_guglani@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Surbhi Bharti |
| Designation |
junior resident |
| Affiliation |
government medical college and hospital chandigarh |
| Address |
department of pediatrics, government medical college and hospital chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7876161007 |
| Fax |
|
| Email |
5surbhib@gmail.com |
|
|
Source of Monetary or Material Support
|
| government medical college and hospital chandigarh |
|
|
Primary Sponsor
|
| Name |
surbhi bharti |
| Address |
girls hostel number 2 government medical college and hospital chandigarh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Surbhi bharti |
government medical college and hospital chandigarh |
outpatient and inpatient department of pediatrics ,government medical college and hospital chandigarh sector 32
Chandigarh
CHANDIGARH |
7876161007
5surbhib@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
glargine once daily |
glargine will be administered once daily in addition to meal time lispro. dose will depend on glycemic control of patient before start of study and will be different for different patients . insulin will be administered subcutaneously and for 3 months |
| Intervention |
glargine will be administered twice daily |
same units of glargine which the patient was previously using (dose will depend on glycemic control of patient before starting study) will be divided into 2 doses administered 12 hours apart subcutaneously in addition to meal time lispro for 3 months duration |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
HbA1c >7.5 on insulin for atleast 1 year
|
|
| ExclusionCriteria |
| Details |
past history of recurrent severe hypoglycemia |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mean difference in HbA1c levels |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hypoglycemic episodes |
3 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In some patient with type 1 diabetes the duration of action of glargine is 20 hrs resulting in hyperglycemia towars the end of 24 hrs hence twice daily dosing will improve glycemic control. Patients 8 to 18 years will be recruited and divided into 2 groups- glargine od versus bd to study mean difference in HbA1c levels |