Clinical Efficacy and Safety of Glimepiride, Empagliflozin and Sitagliptin With Metformin in Type 2 Diabetes Mellitus: A Double and Triple Drug Therapy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This clinical trial aims to evaluate and compare the clinical efficacy and safety of Glimepiride, Empagliflozin, and Sitagliptin with Metformin in newly diagnosed Type 2 Diabetes Mellitus patients. The study will involve 172 participants, aged 30-55, enrolled at the National Medical Centre, Karachi, Pakistan. The study involves four groups, subjects will receive following treatment: Group A will receive Tab Metforrmin 500mg + Tab Glimepiride 2mg (FDC) , Group B Tab Metforrmin 500mg + Tab Empagliflozin 12.5mg (FDC), Group C Tab Metforrmin 500mg + Tab Sitagliptin 50mg (FDC) and Group D Tab Metformin 500mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg per orally, once daily for 90 days. Safety and efficacy will be assessed through anthropometric measurements and lab investigations at baseline, 6 weeks, and 12 weeks, with weekly monitoring of blood sugar levels. The total duration of the study will be 6 months, with a 3-month individual treatment period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 55
Healthy Volunteers: f
View:

• Males and females

• Age 30-55yrs

• HbA1c = ≥ 8.5 \<10 mmol/mol (ADA. 2018)

• BMI \>18.5- \<29.9 (WHO Asian Criteria)

• Treatment naïve patients

• With / without dyslipidemia.

Locations
Other Locations
Pakistan
National Medical Center
RECRUITING
Karachi
Contact Information
Primary
Saima Chandio
saimaabid278@gmail.com
+923337824440
Backup
Nasim Karim
nasimkarim.bumdc@bahria.edu.pk
+923323151774
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 172
Treatments
Active_comparator: Group A: Metformin + Glimepiride (Combination Therapy)
Dual therapy (Fixed Dose Combination):~Tab Metformin 500mg + Tab Glimepiride 2mg Dosage: One tablet per day for 90 days.
Active_comparator: Group B: Metformin + Empagliflozin (Combination Therapy)
Dual therapy (Fixed Dose Combination):~Tab Metformin 500mg + Tab Empagliflozin 12.5mg Dosage: One tablet per day for 90 days.
Active_comparator: Group C: Metformin + Sitagliptin (Combination Therapy)
Dual therapy (Fixed Dose Combination):~Tab Metformin 500mg + Tab Sitagliptin 50mg Dosage: One tablet per day for 90 days.
Active_comparator: Group D: Metformin + Empagliflozin + Sitagliptin (Combination Therapy)
Triple Therapy:~Tab Metformin 500mg + Tab Empagliflozin 12.5mg (Fixed Dose Combination) + Tab Sitagliptin 50mg Dosage: One tablet of each per day for 90 days.
Related Therapeutic Areas
Sponsors
Leads: Bahria University

This content was sourced from clinicaltrials.gov