Health Condition 1: null- Type II Diabetes Mellitus
Conditions
Interventions
Intervention1: Teneligliptin Add on to Metformin: Dose as per routine clinical practice
Control Intervention1: Glimepiride Add on to Metformin: Dose as per routine clinical practice
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient willing to provide informed consent 2.Female or male patient aged 18 years or above 3.Adult patients who had inadequately controlled type 2 diabetes mellitus despite using diet plus exercise and metformin: â?? HbA1C: 7 to 9% â?? FBG: >=140 mg/dL 4.Physician prescribes teneligliptin or glimepiride as an add-on to metformin therapy 5.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 antidiabetic therapy other than glimepiride, teneligliptin and metformin 3.Contraindications for teneligliptin and glimepiride as per respective approved prescribing information 4.Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation 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 occurrence of hypoglycemic episodes between two groups 2. To assess the change in HbA1c levels from baseline to week 24 3. To assess the effect of both the treatments on body weight Timepoint: Baseline, Week 12 and Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the change in FBG and PPBG levels from baseline to week 24 2. To understand the utilization pattern of teneligliptin 3. To assess other adverse events during study durationTimepoint: Baseline, Week 12 and Week 24 | — |
Countries
India
Contacts
Public ContactDr Rahul Mandlik
Torrent Pharmaceuticals Ltd
Outcome results
None listed