CTRI

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CTRI Number

CTRI/2020/03/023714 [Registered on: 02/03/2020] Trial Registered Prospectively

Last Modified On:

21/06/2023

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Evaluation of Efficacy and Safety of Hydroxychloroquine in Patients with Type 2 Diabetes

Scientific Title of Study

A Randomized, Double-blind, Parallel Arm, Dose Optimization Study to Assess Efficacy and Safety of Hydroxychloroquine in Type 2 Diabetes Patients Uncontrolled on Metformin and Sulfonylurea Combination

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
Ipca/HYQP/PIII-18	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Anil Pareek
Designation	President
Affiliation	Ipca Laboratories Ltd.
Address	Medical Affairs and Clinical Research, 142-AB Kandivli Industrial Estate, Kandivli (West) Mumbai (Suburban) MAHARASHTRA 400067 India
Phone	02266474641
Fax
Email	anil.pareek@ipca.com

Details of Contact Person
Scientific Query

Name	Dr Anil Pareek
Designation	President
Affiliation	Ipca Laboratories Ltd.
Address	Medical Affairs and Clinical Research, 142-AB Kandivli Industrial Estate, Kandivli (West) Mumbai (Suburban) MAHARASHTRA 400067 India
Phone	02266474641
Fax
Email	anil.pareek@ipca.com

Details of Contact Person
Public Query
Modification(s)

Name	Nitin Chandurkar
Designation	Vice President
Affiliation	Ipca Laboratories Ltd.
Address	Clinical Research and Development, 142-AB Kandivli Industrial Estate, Kandivli (West) Mumbai (Suburban) MAHARASHTRA 400067 India
Phone	02266474622
Fax
Email	nitin.chandurkar@ipca.com

Source of Monetary or Material Support

Ipca Laboratories Ltd. Plot No. 142-AB, Kandivli Industrial Estate, Kandivli (W) Mumbai-400067

Primary Sponsor

Name	Ipca Laboratories Ltd
Address	Plot No. 142-AB, Kandivli Industrial Estate, Kandivli (W) Mumbai-400067.
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 27
Name of Committee	Approval Status
Bhatia Hospital Medical Research Society Ethics Committee	Approved
Chellaram Diabetes Institute Institutional Ethics Committee	Approved
Ethics Committe, GSVM Medical College	Approved
Ethics Committe, JNU Institute for Medical Sciences and Research Centre	Approved
Ethics Committee All India Institute of Medical Sciences	Approved
Ethics Committee N.R.S. Medical College	Approved
Ethics Committee, MS Ramaiah Medical College and Hospitals	Approved
Ethics Committee, S.M.S. Medical College and Attached Hospitals	Approved
Human Welfare Ethical Committee for Human Sciences and Research Jaipur	Approved
Instituitional Ethics Committee Sparsh Hospital, Sparsh Hospitals and Critical Care Private Limited	Approved
Institutional Ethics Committee All India Institute of Medical Sciences	Approved
Institutional Ethics Committee AMRI Hospitals Ltd.	Approved
Institutional Ethics Committee for M V Hospital and Research Centre	Approved
Institutional Ethics Committee King Georges Medical University	Approved
Institutional Ethics Committee TNMC NAIR HOSPITAL, Topiwala National Medical College Nair Hospital	Approved
Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS), Raipur	Approved
Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar	Submittted/Under Review
Institutional Ethics Committee, JNU, Jaipur	Approved
Institutional Ethics Committee, JSS Medical College and Hospital	Approved
INSTITUTIONAL ETHICS COMMITTEE, K.I.M.S BANGLORE	Approved
Institutional Ethics Committee, Mysore Medical College & Research Institute and Associated Hospitals	Approved
Institutional Ethics Committee, Neelima Hospitals	Approved
Institutional Human Ethics Committee	Approved
Institutional Human Ethics Committee MGMCRI Puducherry	Approved
LPR Ehics Committe, Lifepoint Multispeciality Hospital Pvt. Ltd.	Approved
Marudhar Hospital Ethics Committee	Approved
Vijan Hospital Ethics Committee	Approved

Regulatory Clearance Status from DCGI
Modification(s)

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E119\|\|Type 2 diabetes mellitus without complications,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Hydroxychloroquine	Hydroxychloroquine 200 mg, 300 and 400 administered once daliy for 24 weeks with existing dose of metformin and sulfonylurea (glimepiride/gliclazide)
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Patients diagnosed with type 2 diabetes mellitus who are receiving stable dose of metformin (â‰¥1000 mg/day to â‰¤2000 mg/day) and glimepiride (at least 2 mg/day)/gliclazide (at least 160 mg/day of immediate release formulation or at least 60 mg/day of modified release formulation) for at least 12 weeks 2. Patients with HbA1c between 7.5 % and 10.5 % (Both inclusive) 3. Patients with FPG >125 mg/dL and/or PPG â‰¥200 mg/dL 4. Patients with body weight â‰¥60 kg 5. Patients able to understand and willing to fully comply with study procedures and restrictions 6. Patient ready to give informed consent to participate in the study

ExclusionCriteria

Details

1. Patients with uncontrolled hyperglycemia i.e. FPG >240 mg/dL
2. Patients with Type 1 diabetes
3. Patients with endocrine disorder other than Type 2 diabetes mellitus
4. Patients with a history or presence of any retinopathy of any grade including diabetic retinopathy, evidence of an imminent need for laser therapy, uncorrected visual acuity <20/100, abnormal visual fields, difficulty to examine optic disc, or evidence of retinal pigment epithelial abnormalities and patients with history or risk of macular edema
5. Patients with cardiovascular events i.e. myocardial infarction/acute coronary syndrome, stroke or has undergone coronary artery bypass surgery, percutaneous transluminal coronary angioplasty or transient ischemic attack, or history of congestive heart failure, cardiomyopathy or unstable angina in past.
6. Patients with abnormal renal function (Serum creatinine â‰¥ 1.5 mg/dL for male and â‰¥ 1.4 mg/dL for female)
7. Patients with abnormal liver function (SGOT, SGPT, total bilirubin, or alkaline phosphatase >2.0 times the upper limit of normal values) or active or chronic liver disease or patients with CPK >2.0 times the upper limit of normal value
8. Patients with significantly abnormal counts in hematology, diseases of blood or hematopoietic organs or female patients with Hb <10 g/dL or male patients with Hb <12 g/dL
9. Patients with triglycerides â‰¥ 500 mg/dL
10. Patients with history of G6PD deficiency, aplastic anemia or agranulocytosis, granulocytopenia
11. Patients with history of psoriasis, blisters, porphyria, rash, scaling, scaling eczema
12. Patients with history of myalgia, proximal myopathy, neuropathy including symptomatic autonomic neuropathy
13. Patient with history of neuropsychiatric events, including suicidality
14. Patients with hs-CRP â‰¥ 10 mg/L
15. Patients with systolic BP >180 mmHg and/or diastolic BP >100 mmHg
16. Patients with chronic gastroparesis, active gastrointestinal disorders (gastric and duodenal ulcer)
17. Patient with known history of diabetic ketoacidosis
18. Patients with history of hypoglycemia unawareness (Patients whose blood glucose levels fall below 70 mg/dL but they do not feel any symptoms of hypoglycemia)
19. Patients with malignancy and planned radiological examinations requiring administration of contrasting agents
20. Patients with malabsorption or pancreatitis
21. Patients with dementia or other cognitive impairment prohibiting informed consent
22. Patients with known history of HIV1/HIV2/Hepatitis B or C infection or syphilis infection
23. Patient with any other illness for which hydroxychloroquine is indicated (such as rheumatoid arthritis, systemic lupus erythematosus [SLE])
24. Patients with any other clinically significant abnormalities/disease which may or may not interfere with assessment of disease under evaluation
25. Patients receiving/requiring insulin
26. Patients receiving anti-obesity drugs or undergoing bariatric surgery within 24 weeks prior to consent
27. Patients receiving systemic steroids at the time of consent or have received it in past 3 months
28. Patients with chronic use of non-steroidal anti inflammatory agents
29. Patients receiving concomitant medications known to have an interaction with HCQ
30. Patients receiving drugs known to cause QT prolongation
31. Patients with known history of hypersensitivity to HCQ, or other similar drugs of same chemical class or any other ingredient of the study formulations or with history of any severe allergic disease.
32. Patients with substance abuse within the last year
33. Patients consuming alcohol more than 21 units /week
34. Patients on another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment.
35. Pregnant or lactating women.
36. Women of childbearing potential not practicing contraception

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Pre-numbered or coded identical Containers

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
1. To evaluate mean change in glycated hemoglobin (HbA1c) in HCQ 200 mg group 2. To evaluate mean change in HbA1c in HCQ 300 mg group 3. To evaluate mean change in HbA1c in HCQ 400 mg group	At Week 24 from baseline

Secondary Outcome

Outcome	TimePoints
To evaluate mean change in HbA1c in HCQ 200 mg, HCQ 300 mg and HCQ 400 mg groups	At Week 12 from baseline
To evaluate mean change in fasting plasma glucose (FPG) and 2-hr postprandial plasma glucose (PPG) in HCQ 200 mg, HCQ 300 mg and HCQ 400 mg groups	At Week 12 and Week 24 from baseline
To evaluate mean change in lipid profile (total cholesterol [TC], triglyceride [TG], high density lipoprotein-cholesterol [HDL-C], low density lipoprotein-cholesterol [LDL-C] and non-HDL-C) in HCQ 200 mg, HCQ 300 mg and HCQ 400 mg groups	At Week 12 and Week 24 from baseline
To evaluate mean change in body weight, body mass index (BMI), waist circumference and waist to hip ratio in HCQ 200 mg, HCQ 300 mg and HCQ 400 mg groups	At Week 12 and Week 24 from baseline
To evaluate mean change in high-sensitivity C-reactive protein (hs-CRP), white blood cells (WBC) and erythrocyte sedimentation rate (ESR) in HCQ 200 mg, HCQ 300 mg and HCQ 400 mg groups	At Week 24 from baseline
To evaluate percentage of patients achieving HbA1c level 7.0% in HCQ 200 mg, HCQ 300 mg and HCQ 400 mg groups	At Week 24
To assess the safety and tolerability of study medications based on incidence of adverse events (AEs) (clinical and laboratory), changes in laboratory parameters and incidence of hypoglycemia	Throughout the duration of study

Target Sample Size

Total Sample Size="213"
Sample Size from India="213"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="218"

Phase of Trial

Phase 3

Date of First Enrollment (India)

01/04/2020

Date of Study Completion (India)

28/02/2024

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

This is a randomized, double blind, parallel arm, comparative, multicentric, dose optimization study. A total of 213 patients with type 2 diabetes, receiving at least 1000 mg/day to maximum 2000 mg/day of metformin in combination with glimepiride (at least 2 mg/day) /gliclazide (at least 160 mg/day of immediate release formulation or at least 60 mg/day of modified release formulation) and following routine diet and exercise regime for at least 12 weeks, and satisfying the study inclusion/exclusion criteria will be enrolled in this study. All eligible patients will be divided into one of the three groups in 1:1:1 ratio at baseline/randomization/enrollment visit (Week 0) to receive one of the following 3 treatments:

1. HCQ 200 mg + Matching placebo of HCQ 300 mg and 400 mg for 24 weeks

2. HCQ 300 mg + Matching placebo of HCQ 200 mg and 400 mg for 24 weeks

3. HCQ 400 mg + Matching placebo of HCQ 200 mg and 300 mg for 24 weeks