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Recruiting NCT06862739

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

Phase IV Interventional Diabetes Mellitus Type 2 DM

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Empagliflozin+Linagliptin+Metformin.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2 DM. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Changes in HbA1c levels [Time frame: 03 months, 06 months]
Secondary outcome measures (4)
  • Change in scores of Quality of Life-Short Form "SF-36" questionnaire [Time frame: 06 months]
  • Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ" [Time frame: 06 months]
  • Hypoglycemic events [Time frame: 06 months]
  • Changes in body weight [Time frame: 03 and 06 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 2 centers
  • Faisalabad clinics — Faisalabad
  • Aap ka Clinic — Lahore

Identifiers

NCT: NCT06862739 · NQ/DY/GLX/CT-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗