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NCT Number: NCT06862739

Glycemic Control With Triple Pathway Approach Through Empagliflozin, Linagliptin and Metformin Combination

The efficacy and safety of a triple-pill combination therapy for advanced type 2 diabetes care. The study aims to assess the impact of 3 Oral Anti Diabetic (OAD) drugs on metabolic control, patient compliance, weight management, quality of life, diabetic treatment satisfaction and frequency of hypoglycemic events by combining them into a fixed-dose single pill.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faisalabad clinics, Faisalabad, Punjab Province, Pakistan

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About this study

This study aims to demonstrate that a poly-pill approach combining metformin, linagliptin, and empagliflozin will provide an effective and safe treatment option for managing type 2 diabetes mellitus (T2DM). By focusing on the reduction of HbA1c levels and enhancing patients' quality of life, this simplified approach is expected to streamline medication regimens, reduce pill burden, and improve treatment adherence. Furthermore, the study anticipates that this combination therapy will positively influence weight management and lower the incidence of hypoglycemic events, addressing common challenges in T2DM management. As T2DM prevalence continues to rise, especially in low- and middle-income countries, the poly-pill strategy may offer significant benefits, promoting better compliance, affordable low-in-cost treatment, and facilitating improved long-term health outcomes. Through this research, the study intends to provide strong evidence supporting the poly-pill regimen as a viable and impactful option for global T2DM management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of any gender
  • Patients aged between 18-80 years
  • Patients having HbA1c 8 % or above
  • Patients diagnosed with type II diabetes (more than at least 06 months)
  • Patients already on at least 02 or more anti-diabetic agents
  • Patients not allergic to empagliflozin, linagliptin, or metformin

Exclusion criteria

  • Patients with age less than 18
  • Patients with Type-I diabetes
  • Patients having diabetes for less than 06 months
  • Patients on GLP-1 and GIP
  • Patients who are pregnant or lactating females
  • Patients with decompensated chronic liver disease (DCLD)
  • Patients with eGFR less than 30 ml
  • Patients with end-stage heart failure (NYHA Class 4)
  • Patients who are allergic to empagliflozin, linagliptin, or metformin
  • Patients who are not willing to consent
  • Patients who are unable to give medical history

Treatment and study plan

Empagliflozin+Linagliptin+Metformin

Combination Product

Scarcity of local population data on triple drug combination's impact on compliance, efficacy and safety in diabetic patients

Primary outcomes

  1. Changes in HbA1c levels

    Time frame: 03 months, 06 months

    Metabolic control

Secondary outcomes

  1. Change in scores of Quality of Life-Short Form "SF-36" questionnaire

    Time frame: 06 months

    Improvement in quality of life (before and after treatment)

  2. Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ"

    Time frame: 06 months

    Diabetic treatment satisfaction level (before and after treatment)

  3. Hypoglycemic events

    Time frame: 06 months

    Hypoglycemic events frequency and severity of hypoglycemic events

  4. Changes in body weight

    Time frame: 03 and 06 months

    Increase or decrease in body weight

Sponsors and collaborators

Lead sponsor

Nabiqasim Industries (Pvt) Ltd

Industry

Registry information

Official study title

Glycemic Control With Triple Pathway Approach Through Empagliflozin-Linagliptin-Metformin

Acronym: GLYCO-3P

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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