Clinical trial Recruiting at 2 sites Phase 4 Interventional Ages 18 to 80

Single-pill combination of empagliflozin, linagliptin and metformin for blood sugar control

Official title: Glycemic Control With Triple Pathway Approach Through Empagliflozin-Linagliptin-Metformin

Run by Nabiqasim Industries (Pvt) Ltd · NCT06862739 · Data updated 2026-11-12

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.

More Diabetes Mellitus trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment800 (estimated)
SponsorNabiqasim Industries (Pvt) Ltd
Industry-sponsored
Locations2 sites (Faisalabad, Punjab Province and 1 other locations)
StatusRecruiting
StartedOctober 30, 2025
Main results expectedApril 30, 2026
Study endsJune 30, 2026
Registry record updatedApril 17, 2026
Trial IDNCT06862739 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Faisalabad clinics
    Faisalabad, Punjab Province, Pakistan
    Recruiting
  • Aap ka Clinic
    Lahore, Punjab Province, Pakistan
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.