NCT07452913

Brief Summary

This clinical trial aims to evaluate and compare the comparative efficacy and safety of Metformin-Empagliflozin-Sitagliptin vs. Metformin-Empagliflozin-Linagliptin in newly diagnosed Type 2 Diabetes Mellitus patients. The study will involve 110 participants, aged 30-55, enrolled at the National Medical Centre, Karachi, Pakistan. The study involves two groups, subjects will receive the following treatments: Group A will receive Tab Metformin 1000mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg, whereas Group B will receive Tab Metformin 1000mg + Tab Empagliflozin 12.5mg + Tab Linagliptin 2.5mg (FDC) per orally, once daily, for 90 days. Safety and efficacy will be assessed through anthropometric measurements and lab investigations at baseline, 6 weeks, and 12 weeks, with weekly monitoring of blood sugar levels. The total duration of the study will be 6 months, with a 3-month individual treatment period.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2026

Shorter than P25 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

December 18, 2025

Last Update Submit

February 27, 2026

Conditions

Type 2 Diabetes Mellitus

Keywords

MetforminEmpagliflozinSitagliptinLinagliptin

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome

    Change in HbA1c levels in %

    3 Months

Secondary Outcomes (4)

  • Secondary Outcome : changes in weight from baseline to 12 weeks (kg)

    12 weeks

  • Secondary Outcome: changes in BMI from baseline to 12 weeks (kg/m²).

    12 weeks

  • Secondary outcome: changes in lipid profile (TC, TG, HDL, LDL, VLDL) from baseline to 12 weeks (mg/dl)

    12 weeks

  • Secondary Outcome: To measure safety of Adverse Effects (nausea, vomiting, diarrhea, constipation, UTIs, flu like symptoms, headache, hypoglycemia, weight gain) from baseline to 12 weeks

    12 weeks

Study Arms (2)

Metformin + Empagliflozin (FDC)+ Sitagliptin

ACTIVE COMPARATOR

Metformin decrease hepatic production of glucose. Empagliflozin increase urinary glucose excretion. Sitagliptin increase glucose dependent insulin release.

Drug: Metformin+ Empagliflozin + Sitagliptin

Metformin + Empagliflozin + Linagliptin

ACTIVE COMPARATOR

Metformin reduces hepatic glucose production. Empagliflozin raise excretion of urinary glucose. Sitagliptin increase glucose dependent insulin release.

Drug: Metformin + Empagliflozin + Linagliptin

Interventions

Metformin+ Empagliflozin + SitagliptinDRUG

Group A (Triple Therapy): Tab Metformin 1000mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg, orally, once daily for 90 days

Metformin + Empagliflozin (FDC)+ Sitagliptin
Metformin + Empagliflozin + LinagliptinDRUG

Group B (Triple Therapy) Tab Metformin 1000mg + Tab Empagliflozin 12.5mg + Tab Linagliptin 2.5mg (FDC) orally, once daily, for 90 days.

Metformin + Empagliflozin + Linagliptin

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and Females
  • Age 30-55 years
  • HbA1c = ≥ 8.5 \<10 mmol/mol (ADA. 2025)
  • BMI \>18.5- \<29.9 (WHO Asian Criteria)
  • Treatment naïve patients
  • With / without dyslipidemia

You may not qualify if:

  • HbA1c \>10 mmol/mol
  • BMI \> 30 kg/m²
  • Pregnancy or lactation
  • Systemic diseases such as: hypertension, thyroid, liver, renal diseases etc.
  • Known allergy or intolerance to Metformin, Empagliflozin, Sitagliptin or Linagliptin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Medical Center Karachi

Karachi, Sindh, 75500, Pakistan

Location

Related Publications (10)

  • Ghasemi P, Jafari M, Maskouni SJ, Hosseini SA, Amiri R, Hejazi J, Chambari M, Tavasolian R, Rahimlou M. Impact of very low carbohydrate ketogenic diets on cardiovascular risk factors among patients with type 2 diabetes; GRADE-assessed systematic review and meta-analysis of clinical trials. Nutr Metab (Lond). 2024 Jul 19;21(1):50. doi: 10.1186/s12986-024-00824-w.

    PMID: 39030553BACKGROUND

  • Khan F, Hussain T, Chaudhry TZ, Payal F, Shehryar A, Rehman A, Ramadhan A, Hayat MT, Dabas MM, Khan M. Comparing the Efficacy and Long-Term Outcomes of Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors, Dipeptidyl Peptidase-4 (DPP-4) Inhibitors, Metformin, and Insulin in the Management of Type 2 Diabetes Mellitus. Cureus. 2024 Nov 25;16(11):e74400. doi: 10.7759/cureus.74400. eCollection 2024 Nov.

    PMID: 39723311BACKGROUND

  • Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Kelly T, Irvine K, Peters C, Zhyzhneuskaya S, Hollingsworth KG, Adamson AJ, Sniehotta FF, Mathers JC, McIlvenna Y, Welsh P, McConnachie A, McIntosh A, Sattar N, Taylor R. 5-year follow-up of the randomised Diabetes Remission Clinical Trial (DiRECT) of continued support for weight loss maintenance in the UK: an extension study. Lancet Diabetes Endocrinol. 2024 Apr;12(4):233-246. doi: 10.1016/S2213-8587(23)00385-6. Epub 2024 Feb 26.

    PMID: 38423026BACKGROUND

  • Ahmed AM. History of diabetes mellitus. Saudi Med J. 2002 Apr;23(4):373-8.

    PMID: 11953758BACKGROUND

  • Wilding JPH, Evans M, Fernando K, Gorriz JL, Cebrian A, Diggle J, Hicks D, James J, Newland-Jones P, Ali A, Bain S, Da Porto A, Patel D, Viljoen A, Wheeler DC, Del Prato S. The Place and Value of Sodium-Glucose Cotransporter 2 Inhibitors in the Evolving Treatment Paradigm for Type 2 Diabetes Mellitus: A Narrative Review. Diabetes Ther. 2022 May;13(5):847-872. doi: 10.1007/s13300-022-01228-w. Epub 2022 Mar 20.

    PMID: 35307801BACKGROUND

  • Zhang X, Tong WK, Xia Q, Tang Z. The impact of dipeptidyl peptidase 4 inhibitors on health-related quality of life in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. Qual Life Res. 2024 Dec;33(12):3175-3188. doi: 10.1007/s11136-024-03753-6. Epub 2024 Aug 3.

    PMID: 39096426BACKGROUND

  • Katsimardou A, Theofilis P, Vordoni A, Doumas M, Kalaitzidis RG. The Effects of SGLT2 Inhibitors on Blood Pressure and Other Cardiometabolic Risk Factors. Int J Mol Sci. 2024 Nov 18;25(22):12384. doi: 10.3390/ijms252212384.

    PMID: 39596449BACKGROUND

  • Lopez-Candales A, Monte S, Sawalha K, Norgard NB. Time to revisit the true role of metformin in type 2 diabetes mellitus. Postgrad Med. 2023 Aug;135(6):539-542. doi: 10.1080/00325481.2023.2224036. Epub 2023 Jun 14. No abstract available.

    PMID: 37294638BACKGROUND

  • Zhang L, Zhang Y, Shen S, Wang X, Dong L, Li Q, Ren W, Li Y, Bai J, Gong Q, Kuang H, Qi L, Lu Q, Cheng W, Liu Y, Yan S, Wu D, Fang H, Hou F, Wang Y, Yang Z, Lian X, Du J, Sun N, Ji L, Li G; China Diabetes Prevention Program Study Group. Safety and effectiveness of metformin plus lifestyle intervention compared with lifestyle intervention alone in preventing progression to diabetes in a Chinese population with impaired glucose regulation: a multicentre, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2023 Aug;11(8):567-577. doi: 10.1016/S2213-8587(23)00132-8. Epub 2023 Jul 3.

    PMID: 37414069BACKGROUND

  • Lu X, Xie Q, Pan X, Zhang R, Zhang X, Peng G, Zhang Y, Shen S, Tong N. Type 2 diabetes mellitus in adults: pathogenesis, prevention and therapy. Signal Transduct Target Ther. 2024 Oct 2;9(1):262. doi: 10.1038/s41392-024-01951-9.

    PMID: 39353925BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin PhosphateMetforminempagliflozinLinagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesBiguanidesGuanidinesAmidinesOrganic ChemicalsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingQuinazolines

Study Officials

  • Khalil Ur Rehman, MBBS

    Bahria University, Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MPhil Candidate

Study Record Dates

First Submitted

December 18, 2025

First Posted

March 5, 2026

Study Start

January 1, 2026

Primary Completion

March 30, 2026

Study Completion

June 30, 2026

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)