NCT07452913Enrolling by invitationPhase 4
Metformin, Empagliflozin With Sitagliptin vs Linagliptin in Type 2 Diabetes
Comparative Efficacy and Safety of Metformin-Empagliflozin-Sitagliptin vs. Metformin-Empagliflozin-Linagliptin as Initial Triple Therapy in Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
This clinical trial aims to evaluate and compare the comparative efficacy and safety of Metformin-Empagliflozin-Sitagliptin vs. Metformin-Empagliflozin-Linagliptin in newly diagnosed Type 2 Diabetes Mellitus patients. The study will involve 110 participants, aged 30-55, enrolled at the National Medical Centre, Karachi, Pakistan. The study involves two groups, subjects will receive the following treatments: Group A will receive Tab Metformin 1000mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg, whereas Group B will receive Tab Metformin 1000mg + Tab Empagliflozin 12.5mg + Tab Linagliptin 2.5mg (FDC) 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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 18 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 30 Mar 2026
- Lead sponsor
- Bahria University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07452913
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 110
- From 1 Jan 2026 to the primary completion date, 30 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Systemic diseases such as: hypertension, thyroid, liver, renal diseases etc.
- Known allergy or intolerance to Metformin, Empagliflozin, Sitagliptin or Linagliptin.
Lab values
- HbA1c \>10 mmol/mol
Other
- BMI \> 30 kg/m²
- Pregnancy or lactation
Who the study is looking for
- Males and Females
- Age 30-55 years
- HbA1c = ≥ 8.5 \<10 mmol/mol (ADA. 2025)
- BMI \>18.5- \<29.9 (WHO Asian Criteria)
- Treatment naïve patients
- With / without dyslipidemia
Age in the registry: 30 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Medical Center Karachi Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.