Glycemic Control With Triple Pathway Approach Through Empagliflozin, Linagliptin and Metformin Combination (GLYCO-3P)

April 14, 2026 updated by: Nabiqasim Industries (Pvt) Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalabad, Punjab Province, Pakistan
        • Recruiting
        • Faisalabad clinics
        • Contact:
        • Sub-Investigator:
          • Ahmad Shahzad
        • Sub-Investigator:
          • Aamir Shoukat
        • Sub-Investigator:
          • Muhammad Irfan
      • Lahore, Punjab Province, Pakistan
        • Recruiting
        • Aap ka Clinic
        • Contact:
        • Principal Investigator:
          • Javed Akram
        • Sub-Investigator:
          • Aftab Mohsin
        • Sub-Investigator:
          • Somia Iqtadar
        • Sub-Investigator:
          • Muhammad Imtiaz
        • Sub-Investigator:
          • Akmal Bhatty
        • Sub-Investigator:
          • Azziz Ur Rehman
        • Sub-Investigator:
          • Sajid Obaidullah
        • Sub-Investigator:
          • Tariq Waseem
        • Sub-Investigator:
          • Khalid Mahmud
        • Sub-Investigator:
          • Idrees Bhatti
        • Sub-Investigator:
          • Jaida Manzoor
        • Sub-Investigator:
          • Rizwan Zafar
        • Sub-Investigator:
          • Taj Jamshed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Glem-Lin MXR Single pill combination study

Empagliflozin (25 mg) Linagliptin (5 mg) Metformin XR (1000 mg)

once daily combination therapy
Combination product: Empagliflozin+Linagliptin+Metformin
Scarcity of local population data on triple drug combination's impact on compliance, efficacy and safety in diabetic patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in HbA1c levels
Time Frame: 03 months, 06 months
Metabolic control
03 months, 06 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
06 months
Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ"
Time Frame: 06 months
Diabetic treatment satisfaction level (before and after treatment)
06 months
Hypoglycemic events
Time Frame: 06 months
Hypoglycemic events frequency and severity of hypoglycemic events
06 months
Changes in body weight
Time Frame: 03 and 06 months
Increase or decrease in body weight
03 and 06 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nabiqasim Industries (Pvt) Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2025

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

March 1, 2025

First Posted (Actual)

March 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NQ/DY/GLX/CT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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