| CTRI Number |
CTRI/2009/091/001036 [Registered on: 14/12/2009] |
| Last Modified On: |
22/11/2019 |
| 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)
|
study of hydroxychloroquine in comparison with pioglitazone in patients with type II diabetes mellitus |
Scientific Title of Study
Modification(s)
|
Efficacy and safety of Hydroxychloroquine in the Treatment of Type II Diabetes Mellitus: A Double Blind, Randomized Comparison with Pioglitazone |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ipca/HCQP/PIII-07 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Anil Pareek |
| Designation |
President- Medical Affairs and Clinical Research |
| Affiliation |
Ipca Laboratories Limited |
| Address |
142-AB, Kandivli Industrial Estate, Mumbai, Maharashtra 400067, India
Mumbai
MAHARASHTRA
400067
India |
| Phone |
02266474641 |
| Fax |
02228686954 |
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Anil Pareek |
| Designation |
President |
| Affiliation |
Ipca Laboratories Limited |
| Address |
Medical Affairs & Clinical Research
142-AB, Kandivli Industrial Estate
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-66474641 |
| Fax |
022-28686954 |
| Email |
anil.pareek@ipca.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Nitin Chandurkar Representing Sponsor |
| Designation |
General Manager |
| Affiliation |
Ipca Laboratories Ltd.,Mumbai |
| Address |
Clinical Research & Development
Plot no. 47,Kandivli Industrial Estate; Kandivli(W), Mumbai
Mumbai
MAHARASHTRA
400067
India |
| Phone |
022-61112318 |
| Fax |
022-28686954 |
| Email |
nitin.chandurkar@ipca.com |
|
|
Source of Monetary or Material Support
|
| Ipca Laboratories Limited, 142-AB, Kandivli Industrial Estate, Kandivli (West) Mumbai: 400067 |
|
Primary Sponsor
Modification(s)
|
| Name |
Ipca Laboratories Limited |
| Address |
Plot no. 142 AB, Kandivli Industrial Estate, Kandivli(W), Mumbai-400067 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 17 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr NB Vijaykumar |
Andhra Medical College & KGMC, Visakhapatnam |
Andhra Medical College and King Georte Hospital Visakhapatnam 530002
Visakhapatnam
ANDHRA PRADESH |
09246614443
drvijaykumarnb@yahoo.co.in |
| Dr Asha Shah |
B.J.Medical College and Civil Hospital Ahmedabad |
2nd Floor Department of Medicine B.J.Medical College and Civil Hospital
Ahmedabad 380016
Ahmadabad
GUJARAT |
09327066349
navneetasha@yahoo.com |
| Dr Sudhir Bhandari |
Bhandari Clinic and Research Center Jaipur |
Ground floor D126A Krishna Marg Bapu Nagar
Jaipur 302015
Jaipur
RAJASTHAN |
09829078844
dr.bhandaricr@gmail.com |
| Dr SS Devarmani |
BLDEUs Shri. B.M. Patil Medical College, Bijapur |
BLDEUs Shri B. M. Patil Medical College Bijapur 586103
Bijapur
KARNATAKA |
09342611512
shashidhardevarmani@indiatimes.com |
| Dr N K Thulasidharan |
Calicut Medical College and Hospital, Calicut |
Ground floor OPD number 67 Calicut Medical College and Hospital Mavoor road
Calcut-673008
Kozhikode
KERALA |
09847955875
dr_thulasidharan@yahoo.com |
| Dr Nihal Thomas |
Christian Medical College Vellore |
Department of Endocrinology Diabetes and Metabolism 2nd floor Christian Medical College
Vellore 632004
Vellore
TAMIL NADU |
09843111996
nihal_thomas@yahoo.com |
| Dr Banshi Saboo |
Dia care A complete Diabetes Care Center |
Ground floor opd room number 1 1 and 2 Gandhi Park Near Nehru Nagar Cross Road Ambawadi Ahmedabad
Ahmadabad
GUJARAT |
09824047676
banshisaboo@hotmail.com |
| Dr. Navneet Agrawal |
DIabetes Obesity & Thyroid Center, Gwalior |
Lalitpur Colony, Hospital Colony,Gwalior-474001
Gwalior
MADHYA PRADESH |
09425145758
navneetdotc@gmail.com |
| Dr Alaka Deshpande |
Grant Medical College & JJ Hospital, Mumbai |
Grant Medical College and Sir J J Group of Hospitals, Byculla, Mumbai 400008
Mumbai
MAHARASHTRA |
09869168886
alakadeshpande@rediffmail.com |
| Dr S D Zawar |
Indira Gandhi Medical College & Mayo Hospital, Nagpur |
Indira Gandhi Government Medical College, Nagpur-440018
Nagpur
MAHARASHTRA |
09422145091
sdzawar@yahoo.com |
| Dr M Mahesh |
JSS Medical College and Hospital, Mysore |
JSS Medical College and Hospital, Ramanuja Road, Mysore
Mysore
KARNATAKA |
09845114166
doctmahesh@yahoo.com |
| Dr Vijay Viswanathan |
M V Hospital for Diabetes and Diabetes Research Center Chennai |
Ground Floor OPD number 1 No 4 West Madha Church Street Royapuram
Chennai 600013
Chennai
TAMIL NADU |
09840055535
vijayviswanathan92@gmail.com |
| Dr O P Gupta |
Mahatma Gandhi Institute of Medical Sciences |
Department OF Medicine, Mahatma Gandhi Institute of Medical Sciences, Dhanwantri Nagar, Warud, PO Sewagram, Wardha - 442102
Wardha
MAHARASHTRA |
91-7152-284341
gupta_op@hotmail.com |
| Dr Kunal Kothari |
Mahatma Gandhi Medical College & Hospital, Jaipur |
Mahatma Gandhi Medical College and Hospital, RIICO Institutional area, Sitapura, Jaipur 302022
Jaipur
RAJASTHAN |
09829066158
drkunalkothari.69@gmail.com |
| Dr A L Kakrani |
Padmashree Dr. D. Y. Patil Medical College, Pimpri, Pune |
Padmashree D Y Patil Meical College Hospital and Research Centre,Pimpri Pune 411018
Pune
MAHARASHTRA |
09823972424
kakrani@hotmail.com |
| Dr Milind Chandurkar |
Pravara Rural Hospital, Loni (Budrug) |
Rural Medical College PO Loni BK Dist Ahmednagar 413736
Ahmadnagar
MAHARASHTRA |
09960416211
drmilindch@gmail.com |
| Dr PD Khandelwal |
SMS Medical College & Hospital, Jaipur |
SMS Medical College and Hospital Jaipur 302004
Jaipur
RAJASTHAN |
09214403945
skant_sunita@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 17 |
| Name of Committee |
Approval Status |
| Bharti Research Institute of Diabetes & Endocrinology, IEC, Karnal |
Approved |
| Dia Care Research Ethics Committee |
Approved |
| Ethics Committee of Prof M Viswanathan Diabetes Research Center, Chennai |
Approved |
| Institutional Ethical Committee, Dr. B.M. Patil Medical College, Bijapur |
Approved |
| Institutional Ethics Committee Grant Medical College and sir J J Group of Hospital, Mumbai |
Approved |
| Institutional Ethics Committee Mahatma Gandhi Institiute of Medical Sciences, Sevagram, Wardha |
Approved |
| Institutional Ethics Committee Medical College Calicut |
Approved |
| Institutional Ethics Committee Padmashree Dr. DY Patil Medical College, Pune |
Approved |
| Institutional Ethics Committee, IGMC, Nagpur |
Approved |
| Institutional Ethics Committee, KGMC, Visakhapatnam |
Approved |
| Institutional Ethics Committee, Mysore |
Approved |
| Institutional Review Board Christian Medical College Vellore |
Approved |
| Mahatma Gandhi Medical College & Hospital, Jaipur |
Approved |
| Pravara Medical Trusts Pravara Rural Hospital |
Approved |
| SMS Hospital, Jaipur |
Approved |
| Swasthya Kalyan Ethics Committee |
Approved |
| The Ethics Committee B J Medical College and Civil Hospital Ahmedabad |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, Type II Diabetes Mellitus, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Hydroxychloroquine |
400 mg orally once daily for 6 months |
| Comparator Agent |
Pioglitazone |
15 mg orally Once daily for 6 months |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed of type II diabetes defined by ADA criteria and are uncontrolled by combination therapy of two oral hypoglycemic agents i.e. either metformin greater than or equal to 1000mg/day in combination with glimepiride greater than or equal to 4mg/day or gliclazide greater than or equal to 160mg/day combination
3. Patients with HbA1c greater than or equal to 7.5 % and less than or equal to 11.5 % at baseline visit (HbA1C 7.5 % and less than or equal to 11.5 % for screening visit)
4. Patients with body weight greater than or equal to 60 kg
5. Patients willing and likely to fully comply with study procedures and restrictions and ready to give written informed consent |
|
| ExclusionCriteria |
| Details |
1. Patients with other than Type II diabetes
2. Patients with a history of any retinopathy including diabetic retinopathy
3. Patients with abnormal renal and liver function.
4. Patients with disease of blood or haematopoetic organs
5. Patient with known history of diabetic ketoacidosis
6. Patients receiving insulin therapy
7. Patients with known history of hypersensitivity to hydroxychloroquine, glimepiride, gliclazide, metformin , pioglitazone or other similar drugs of same chemical class or any other ingredient of the study formulations or with history of severe allergic disease
8. Pregnant or lactating women.
9. Women of childbearing potential not practicing contraception. |
|
Method of Generating Random Sequence
Modification(s)
|
Permuted block randomization, fixed |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Double Blind Double Dummy |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Mean change in FBG, PPG and HbA1C |
At week 12 and week 24 from baseline |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Clinical improvement in terms of HbA1c, FBG and PPG levels, To assess the safety and tolerability of test product as compaired to reference product characterised by changes in liver function test opthalmologic changes at week 12 and week 24 post randomization. |
at week 12 and week 24 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="252"
Sample Size from India="252"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="267" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
28/04/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/07/2013 |
Estimated Duration of Trial
Modification(s)
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Efficacy and Safety of Hydroxychloroquine in the Treatment of Type 2 Diabetes Mellitus: A Double Blind Randomized Comparison with Pioglitazone. Current Medical & Research Opinion 2014; 1-10 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group, multicentre trial comparing the safety and effecacy of hydroxychloroquine 400 mg and pioglitazone 15 mg in patients with type II diabetes mellitus.
In this study, patients receiving gliclazide/glimepiride+ metformin with uncontrolled type II diabetes will undergo a pre run-in period of upto 1 month (if required), followed by run-in period (compulsory for 3 months). Patients uncontrolled after run-in period will be randomized to receive either hydroxychloroquine 400 mg or pioglitazone 15 mg for 6 months in addition to the previous therapy that they were receiving. |