Treatment of Hydroxychloroquine in Type 2 Diabetes Patients Uncontrolled on Metformin Monotherapy

Phase 3

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2021/11/037750
• Lead Sponsor: Ipca Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients diagnosed with T2D who are receiving stable dose of metformin (>=1000 mg/day) for at least 12 weeks

2.Patients with HbA1c between 7.0 % and 10 % (Both inclusive)

3.Patients with FPG >125 mg/dL and/or PPG >=200 mg/dL

4.Patients with body weight >=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

Exclusion Criteria

1.Patients with uncontrolled hyperglycemia i.e. FBG >240 mg/dL

2.Patients with Type 1 diabetes

3.Patients with endocrine disorders 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 QT prolongation (>=450 ms), ventricular arrhythmia or torsades de pointes

6.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

7.Patients with abnormal renal function (serum creatinine >=1.5 mg/dL for male and >=1.4 mg/dL for female)

8.Patients with abnormal liver function (SGOT, SGPT, total bilirubin, or alkaline phosphatase >2.5 times the upper limit of normal values) or active or chronic liver disease or patients with CPK >2.5 times the upper limit of normal value

9.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

10.Patients with triglycerides >= 500 mg/dL

11.Patients with history of G6PD deficiency, aplastic anemia or agranulocytosis, granulocytopenia

12.Patients with history of psoriasis, blisters, porphyria, rash, scaling, scaling eczema

13.Patients with history of myalgia, proximal myopathy, neuropathy including symptomatic autonomic neuropathy

14.Patients with hs-CRP >=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.Patients 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 HCQ is indicated (such as rheumatoid arthritis [RA], systemic lupus erythematosus [SLE] etc.)

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 other OHA

27.Patients receiving anti-obesity drugs or undergoing bariatric surgery within 24 weeks prior to consent

28.Patients receiving systemic steroids at the time of consent or have received it in past 3 months

29.Patients with chronic use of non-steroidal anti inflammatory agents

30.Patients receiving concomitant medications known to have an interaction wit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare mean change in glycated hemoglobin (HbA1c) between HCQ group and placebo groupTimepoint: At Week 24 from baseline