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

Hydroxychloroquine as Add On Therapy Patients of Type 2 Diabetes Mellitus Uncontrolled on Sulfonylurea and Metformin Combination Comparison with Gliptinsâ?? real world Efficacy assessment in India (HOPE INDIA study) - HOPE-INDIA

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/06/014382
Enrollment
2000
Registered
2018-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Uncontrolled Type 2 Diabetes

Interventions

Control Intervention1: 1. Hydroxychloroquine 400 mg 2. Sitagliptin 100 mg/ Vildagliptin 100 mg/ Teneligliptin 20 mg: Type 2 Diabetes, 1. Hydroxychloroquine 400 mg - Once Daily oral for 3 months 2. Sit

Sponsors

Patna Medical College
Lead Sponsor

Eligibility

Inclusion criteria

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

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 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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

India

Contacts

Public ContactManish Kumar

Dept. Of Medicine, Patna Medical College & Hospital

drp.yugal@rediffmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026