ClinicalTrials.gg
RecruitingNCT06862739GLYCO-3PUpdated Apr 17, 2026

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

A Phase 4 interventional study of Empagliflozin+Linagliptin+Metformin in Diabetes Mellitus and Type 2 DM, sponsored by Nabiqasim Industries (Pvt) Ltd. Recruiting at 2 sites in Pakistan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Nabiqasim Industries (Pvt) Ltd · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Oct 2025; still recruiting 1 year later.
Phase
Phase 4
Study type
Interventional
Enrollment
800
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 40 studies testing empagliflozin in Diabetes Mellitus — 8 open to participants now, 8 under way, none of them phase 3. empagliflozin · Diabetes Mellitus.

Planned enrollment
Largest of 40
800 · median 62
Started
2025
with 2 others
Phase 4
23 of 40
5 open now
Registered
33rd of 40
by date

Among the 40 studies testing empagliflozin in Diabetes Mellitus, this one has the largest planned enrollment, is one of 3 that started in 2025, is one of 23 in phase 4, and was the 33rd registered.

Diabetes Mellitus

8,291 studies on the registry are indexed under Diabetes Mellitus; 1,075 are open to participants now.

Browse Diabetes Mellitus studies →

Open to participants now

8 of the 40 studies testing empagliflozin in Diabetes Mellitus are open now, in 4 countries. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 8 open studies →

About empagliflozin

empagliflozin: first FDA approval 2014 (JARDIANCE), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 649 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 197 (30%) stop at 75 or younger; 88 take children under 18; 183 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 40 studies testing empagliflozin in Diabetes Mellitus, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Diabetes Mellitus
  • Type 2 DM

Keywords

  • Combination
  • empagliflozin
  • metformin
  • linagliptin
  • compliance
  • Hypoglycemic events
  • weight management
  • quality of life
  • treatment satisfaction
  • glycemic control
  • Type 2 DM
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients of any gender
  2. Patients aged between 18-80 years
  3. Patients having 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

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 less than 30 ml
  8. Patients with end-stage heart failure ( 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
800 participants (estimated)

Study arms

  • 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

Interventions

  • Combination productEmpagliflozin+Linagliptin+Metformin

    Drug pages: Empagliflozin · Linagliptin · Metformin

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

06

What researchers measure

Primary outcomes

  1. Changes in HbA1c levels

    Metabolic control

    Time frame: 03 months, 06 months

Secondary outcomes

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

    Improvement in quality of life (before and after treatment)

    Time frame: 06 months

  2. Changes in Diabetic Treatment Satisfaction Questionnaire "DTSQ"

    Diabetic treatment satisfaction level (before and after treatment)

    Time frame: 06 months

  3. Hypoglycemic events

    Hypoglycemic events frequency and severity of hypoglycemic events

    Time frame: 06 months

  4. Changes in body weight

    Increase or decrease in body weight

    Time frame: 03 and 06 months

07

Study locations

2 of 2 sites recruiting
  • Faisalabad clinics
    Faisalabad, Punjab Province, Pakistan
    Recruiting
    • Ahmad Shahzad · ContactNQmedicalaffairs@gmail.com · 0329
    • Ahmad Shahzad · Sub investigator
    • Aamir Shoukat · Sub investigator
    • Muhammad Irfan · Sub investigator
  • Aap ka Clinic
    Lahore, Punjab Province, Pakistan
    Recruiting
    • Assia Bukhari Research Coordinator, M Phil · ContactAssia Bukhari <assia.bukhari.pk@gmail.com> · 03296922380
    • Javed Akram · Principal 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 · Sub investigator
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Apr 2026, 6 months after the start.

Of 48 industry-sponsored phase 4 interventional studies under Diabetes Mellitus, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 22. This study's planned 6 months is below that.

Counting every sponsor, half of 197 studies reached it within 24 months; a quarter within 13 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2025
First posted
Mar 6, 2025
StartActual
Oct 30, 2025
Primary completionEst.
Apr 30, 2026
CompletionEst.
Jun 30, 2026
Last update
Apr 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06862739
Lead sponsor
Nabiqasim Industries (Pvt) Ltd
Responsible party
Sponsor
First posted
Mar 6, 2025
Start date
Oct 30, 2025
Primary completion
Apr 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Apr 17, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Studies of the drugs tested here: Empagliflozin · Linagliptin · Metformin

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