Single-pill combination of empagliflozin, linagliptin and metformin for blood sugar control
Glycemic Control With Triple Pathway Approach Through Empagliflozin-Linagliptin-Metformin
This test tries a single pill that combines empagliflozin, linagliptin, and metformin to lower blood sugar and simplify treatment for adults with type 2 diabetes who have HbA1c of 8% or higher and are already on two or more diabetes medicines.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nabiqasim Industries (Pvt) Ltd Industry-sponsored |
| Locations | 2 sites (Faisalabad, Punjab Province and 1 other locations) |
| Trial ID | NCT06862739 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional study gives adults with longstanding type 2 diabetes a fixed-dose single pill containing empagliflozin, linagliptin, and metformin and follows clinical outcomes at outpatient clinics in Punjab, Pakistan. Key outcomes include change in HbA1c, treatment adherence, weight, frequency of hypoglycemic events, quality of life, and treatment satisfaction. Eligible participants are adults aged 18–80 with T2DM for at least six months, HbA1c ≥8%, and already taking two or more oral anti-diabetic agents; major exclusions include severe renal impairment, type 1 diabetes, pregnancy, and recent use of GLP-1/GIP therapies. The study aims to test whether combining three oral agents into one fixed-dose pill can reduce pill burden and improve real-world metabolic control and patient-reported outcomes.
Who should consider this trial
Good fit: Adults aged 18–80 with type 2 diabetes for at least six months, HbA1c of 8% or higher, already taking two or more anti-diabetic drugs, without allergy to empagliflozin, linagliptin, or metformin, and with adequate kidney function are ideal candidates.
Not a fit: Patients with type 1 diabetes, diabetes duration under six months, eGFR below 30 mL/min, pregnant or lactating women, those on GLP-1/GIP therapies, or with end-stage heart failure are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the triple-pill could simplify medication regimens, improve adherence, and lead to better blood sugar control with potential benefits for weight and fewer hypoglycemic episodes.
How similar studies have performed: Prior studies combining SGLT2 inhibitors, DPP-4 inhibitors, and metformin have shown improved glycemic control and acceptable safety, though fixed-dose triple-pill formulations have been less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria 1. Patients of any gender 2. Patients aged between 18-80 years 3. Patients having HbA1c 8 % or above 4. Patients diagnosed with type II diabetes (more than at least 06 months) 5. Patients already on at least 02 or more anti-diabetic agents 6. Patients not allergic to empagliflozin, linagliptin, or metformin Exclusion criteria 1. Patients with age less than 18 2. Patients with Type-I diabetes 3. Patients having diabetes for less than 06 months 4. Patients on GLP-1 and GIP 5. Patients who are pregnant or lactating females 6. Patients with decompensated chronic liver disease (DCLD) 7. Patients with eGFR less than 30 ml 8. Patients with end-stage heart failure (NYHA Class 4) 9. Patients who are allergic to empagliflozin, linagliptin, or metformin 10. Patients who are not willing to consent 11. Patients who are unable to give medical history
Where this trial is running
Faisalabad, Punjab Province and 1 other locations
- Faisalabad clinics — Faisalabad, Punjab Province, Pakistan (Recruiting)
- Aap ka Clinic — Lahore, Punjab Province, Pakistan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.