A clinical study to understand the combined effects of Sitagliptin & metformin, in comparison to Glimepiride & metformin treatment in type 2 diabetes patients

Comparing the Efficacy and Safety of Sitagliptin and Glimepiride in combination with Metformin in Geriatric Type 2 Diabetes Mellitus patients - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065877

Enrollment

Registered

2024-04-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Sitagliptin & Metformin: Sitagliptin 100mg OD Metformin 500mg BD Both for 3 months Intervention2: Sitagliptin & Metformin: Glimepiride & Metformin Control Intervention1: Glimepiride & M

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with more than 60 year of age 2. Newly diagnosed patients with Type 2 Diabetes Mellitus as defined by the International Diabetes Federation (IDF) guidelines 2021 3. Patients who either newly diagnosed or drug naive T2DM patients 4. Patients with uncontrolled T2DM on metformin monotherapy (fasting plasma glucose level of more than or equal to 126 mg/dL and less than or equal to 200 mg/dL and/or 2 h postprandial plasma glucose less than or equal to 200 mg/dl and/or glycosylated hemoglobin [HbA1c] levels more than or equal to 7.5% and less than or equal to 10% at screening) 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Patient not willing to give informed consent 2. Patients of Type I Diabetes Mellitus 3. Hypersensitivity to any of the used drugs. 4. Pregnant and lactating females 5. Cardiac failure, Liver and kidney dysfunction or severe anemia 6. Patients requiring insulin for glycemic control and/or history of insulin usage during 3 months preceding enrollment 7. Patients with serious cardiovascular disease (NYHA class I-IV CHF or history of MI or stroke) or cerebrovascular conditions within 6 months before enrolment.

Design outcomes

Primary

Measure	Time frame
Change from baseline in HbA1cTimepoint: 12 weeks	—

Secondary

Measure	Time frame
1. Change from baseline in FPG 2. Change in BMI from baseline 3. Change from baseline in HDL Cholesterol 4. Change from baseline in LDL Cholesterol 5. Change from baseline in Serum Total Triglyceride 6. Change from baseline in Total Cholesterol Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Keerthi Rajan M

King George Medical University, Lucknow

drsanjaykhattri@gmail.com9415008055

Outcome results

None listed

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