AzTrials
AzTrials

Diabetes MellitusPhase 4GLYCO-3PNCT06862739

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

A Phase 4 study testing Empagliflozin+Linagliptin+Metformin in people with Diabetes Mellitus and Type 2 DM, run by Nabiqasim Industries (Pvt) Ltd at 2 sites in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2 DM
What is being tested?
Empagliflozin+Linagliptin+Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
2 sitesPakistan
Study dates
30 Oct 2025to 30 Jun 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pakistan2 sites, 2 recruiting

  • Faisalabad clinics

    Faisalabad, Punjab Province

    Ahmad Shahzad, 0329, NQmedicalaffairs@gmail.com

    Ahmad Shahzad

    Recruiting

  • Aap ka Clinic

    Lahore, Punjab Province

    Assia Bukhari Research Coordinator, M Phil, 03296922380, Assia Bukhari <assia.bukhari.pk@gmail.com>

    Javed Akram

    Recruiting

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
Empagliflozin+Linagliptin+Metformin
Keywords
Combination, empagliflozin, metformin, linagliptin, compliance, Hypoglycemic events, weight management, quality of life, treatment satisfaction, glycemic control, Type 2 DM
Medical subject headings
Diabetes Mellitus, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin+Linagliptin+MetforminCombination product

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

Study groups in NCT06862739
Study groupRoleWhat they receive
Glem-Lin MXR Single pill combination studyOtherEmpagliflozin (25 mg) Linagliptin (5 mg) Metformin XR (1000 mg) once daily combination therapy
Receives: Combination Product: Empagliflozin+Linagliptin+Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in HbA1c levels

    Metabolic control

    Measured: 03 months, 06 months

Secondary outcomes (4)

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

    Improvement in quality of life (before and after treatment)

    Measured: 06 months

  2. Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ"

    Diabetic treatment satisfaction level (before and after treatment)

    Measured: 06 months

  3. Hypoglycemic events

    Hypoglycemic events frequency and severity of hypoglycemic events

    Measured: 06 months

  4. Changes in body weight

    Increase or decrease in body weight

    Measured: 03 and 06 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2025
  2. Study start30 Oct 2025
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
1
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06862739
Sponsor's protocol ID
NQ/DY/GLX/CT-001
Acronym
GLYCO-3P
Status last verified
Apr 2026
First submitted
19 Feb 2025
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Empagliflozin+Linagliptin+Metformin in people with Diabetes Mellitus and Type 2 DM, run by Nabiqasim Industries (Pvt) Ltd at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in HbA1c levels (time frame: 03 months, 06 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06862739.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in