Health Condition 1: null- Diabetes Mellitus Type II with Chronic Kidney Disease
Conditions
Interventions
None listed
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Treatment naïve adult patients or adult patients who had inadequately controlled type 2 diabetes mellitus despite using diet plus exercise and/or OADs: HbA1C >6.5% FBG >=140 mg/dL eGFR 2.Physician prescribes teneligliptin as a monotherapy or add-on 3.Patients must provide written consent to use personal and/or health data prior to the entry into the study
Exclusion criteria
Exclusion criteria: 1. Patients with Type 1 diabetes mellitus 2. Patient on DPP-4 inhibitor other than teneligliptin and GLP-1 analogue therapy 3. Contraindications for teneliglitpin as per approved local prescribing information 4. Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participation of subject in the study 5. Pregnant and lactating woman and women of child bearing potential not ready to use an effective barrier contraceptive method during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the change in HbA1c levels from baseline to week 12 and 24 2.To assess the change in Estimated Glomerular Filtration Rate (eGFR) level from baseline to week 24 Timepoint: At baseline Week 12 Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the change in FBG and PPBG levels from baseline to week 12 and 24 2. To assess the change in albumin-creatinine ratio (ACR) from baseline to week 24 3. To understand usage pattern of teneligliptin in CKD patients as a monotherapy or add-on with other OADs 4. To assess adverse events during study duration Timepoint: At baseline to week 12 and 24 | — |
Countries
India
Contacts
Public ContactDr Rahul Mandlik
Torrent Pharmaceuticals Ltd
Outcome results
None listed