Health Condition 1: E119- Type 2 diabetes mellitus without complications Health Condition 2: null- Type II Diabetes Mellitus
Conditions
Interventions
Intervention1: Hydroxychloroquine: 400 mg orally once daily for 6 months
Control Intervention1: Pioglitazone: 15 mg orally Once daily for 6 months
Sponsors
Ipca Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: at week 12 and week 24 | — |
Primary
| Measure | Time frame |
|---|---|
| Mean change in FBG, PPG and HbA1CTimepoint: At week 12 and week 24 from baseline;Mean change in FBG, PPG and HbA1CTimepoint: At week 12 and week 24 from baseline;Mean change in FBG, PPG and HbA1CTimepoint: At week 12 and week 24 from baseline | — |
Countries
India
Contacts
Public ContactNitin Chandurkar Representing Sponsor
Ipca Laboratories Limited
Outcome results
None listed