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 Metformin

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 Metformin : A Real-World Study in India - N/A

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070821

Enrollment

Registered

2024-07-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

Interventions

Intervention1: Group 1-Vildagliptin 50 MG + Metformin: Route of administration- Oral Dosage form- Tablet Frequency- twice daily Study Duration- 14 days Intervention2: Group 2-Vildagliptin 100 MG + Me

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Baseline Reading & Final Reading of 48 hrs. CGM will be noted & compared. Assessment of Average Daily Glucose (ADG) at baseline and 14 days. Assessment of Time in target at baseline and 14 days. Assessment of time below target at baseline and 14 days. Assessment of time above target at baseline and 14 days.Timepoint: Baseline Reading, 48 hrs.and 14 days of treatment period.	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Rishikesh Shewale

SKN Diabetes and Endocrine Clinic

dr_supratik@yahoo.co.uk9830585954

Outcome results

None listed

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