Effect of Oral Hypoglycemics in Combination

Safety and Efficacy of Commonly Used Second line Oral Hypoglycaemic Agents Added to Metformin Monotherapy in Patients with Type 2 Diabetes Mellitus - A Randomized Open Label Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012561

Enrollment

120

Registered

2018-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: null- Type 2 Diabetes Mellitus

Interventions

Intervention1: Glimepiride: Up to 4mg Once Daily for 12 Weeks Control Intervention1: Sitagliptin: 50 or 100 mg Once Daily for 12 Weeks Control Intervention2: Dapagliflozin : 10mg Once Daily for 12 We

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Type 2 diabetes mellitus HbA1C Greater than or Equal to 6.5 % eGFR Greater than or Equal to 60 ml/min Patients willing to give informed consent

Exclusion criteria

Exclusion criteria: Patients with CKD (stage 3 and above) or on dialysis Patients with Type 1 diabetes mellitus Pregnancy/Lactating Women Acute Liver disease Diabetic ketoacidosis Patients with Psychiatric disorders

Design outcomes

Primary

Measure	Time frame
HbA1c Post Prandial Blood Glucose Fasting Blood Glucose and Glycaemic Variability TestTimepoint: After 12 Weeks	—

Secondary

Measure	Time frame
ADRsTimepoint: Every 4 Weeks	—

Countries

India

Contacts

Public ContactProf KS Lakshmi

SRM Medical College Hospital and Research Centre

drkumarjs@gmail.com

Outcome results

None listed

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