Hydroxychloroquine real world efficacy assessment as add on therapy compare to gliptin in India

Phase 4

Completed

• Conditions: Health Condition 1: null- Uncontrolled Type 2 Diabetes

• Registration Number: CTRI/2018/06/014382
• Lead Sponsor: Patna Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-07-12
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2000

Inclusion Criteria

Patients receiving stable doses of sulfonylurea and at least 1000 mg metformin for at least 3 months with HbA1c >=7%

Patients with ideal body weight > 60 kg Compliance

Patient able to understand and willing to fully comply with study procedures and restrictions.

Patients ready to undergo a follow-up period of 24 weeks.

Exclusion Criteria

Patients with other than type 2 diabetes (Type 1 diabetes).

Patients with a history of any retinopathy of any grade including diabetic retinopathy, evidence of an imminent need for retinal 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.

Patients with history of myalgia, aplastic anemia or agranulocytosis, granulocytopenia, psoriasis, porphyria, rash, scaling, scaling eczema, and G6PD deficiency.

Patients with significant cardiovascular illness limiting participation of patient in a clinical trial

Patients with abnormal renal function (Serum Cr >1.5 mg/dL, BUN > 20 mg/dL).

Patients with abnormal liver function (AST and ALT, total bilirubin or alkaline phosphatase > 2.5 times the upper limit of normal values).

Pregnant or lactating women

Women of childbearing potential not practicing contraception

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare mean change in glycated hemoglobin (HbA1c) levels at Week 12 from baseline between and within treatment groups.Timepoint: To evaluate and compare mean change in glycated hemoglobin (HbA1c) levels at Week 12 from baseline between and within treatment groups.

Secondary Outcome Measures

Name	Time	Method
To evaluate and compare mean change in HbA1c levels at Week 12 from baseline between and within treatment groups. <br/ ><br> <br/ ><br>To compare the percentage of patients achieving HbA1c level of 7.0% between treatmentgroups at the end of Week 12 and Week 24. <br/ ><br>Change in serum creatinine HOMA Ã? and HOMA IR <br/ ><br>Timepoint: 3 Months