A Real-World Study in India to Comparison of Vildagliptin Twice Daily Vs Vildagliptin Once Daily Sitagliptin Once Daily and Linagliptin Once Daily Therapy using Continuous Glucose Monitoring in Type 2 Diabetes Mellitus Patients Uncontrolled on Metformi
- Conditions
- Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications
- Registration Number
- CTRI/2024/07/070821
- Lead Sponsor
- Emcure Pharmaceutical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Adult patients either gender greater than 18 to less than 65 years of age with T2DM Uncontrolled on Metformin Therapy maximum tolerated daily dose of at least 1500 mg
Patients who are having HbA1c greater than 7.5 percent.
Patients who are willing and able to give informed consent.
Patients below 18 years of age of either gender
Patients who are Prediabetic
Patients who had taken insulin and antidiabetic agents other than metformin in last 3 months
Patients with Type 1 diabetes
Female patients who were pregnant or breast feeding
Presence of any other clinically significant disease or laboratory findings that in the Investigators opinion may affect the study outcomes or continued participation of patient in the study
Participation in another study concurrently or within 4 weeks prior to initiation of treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Baseline Reading & Final Reading of 48 hrs. CGM will be noted & compared. <br/ ><br> <br/ ><br>Assessment of Average Daily Glucose (ADG) at baseline and 14 days. <br/ ><br> <br/ ><br>Assessment of Time in target at baseline and 14 days. <br/ ><br> <br/ ><br>Assessment of time below target at baseline and 14 days. <br/ ><br> <br/ ><br>Assessment of time above target at baseline and 14 days.Timepoint: Baseline Reading, 48 hrs.and 14 days of treatment period.
- Secondary Outcome Measures
Name Time Method Adverse events (AE) or serious adverse events (SAE), either spontaneously reported by the patient, or noticed by the investigator will be recorded during the study.Timepoint: at 13 days and 14 days