Glimepiride, Empagliflozin, and Sitagliptin With Metformin for Type 2 Diabetes

April 9, 2026 updated by: Saima Chandio, Bahria University

Clinical Efficacy and Safety of Glimepiride, Empagliflozin and Sitagliptin With Metformin in Type 2 Diabetes Mellitus: A Double and Triple Drug Therapy

This clinical trial aims to evaluate and compare the clinical efficacy and safety of Glimepiride, Empagliflozin, and Sitagliptin with Metformin in newly diagnosed Type 2 Diabetes Mellitus patients.

The study will involve 172 participants, aged 30-55, enrolled at the National Medical Centre, Karachi, Pakistan. The study involves four groups, subjects will receive following treatment: Group A will receive Tab Metforrmin 500mg + Tab Glimepiride 2mg (FDC) , Group B Tab Metforrmin 500mg + Tab Empagliflozin 12.5mg (FDC), Group C Tab Metforrmin 500mg + Tab Sitagliptin 50mg (FDC) and Group D Tab Metformin 500mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate and compare the clinical efficacy and safety of Glimepiride, Empagliflozin and Sitagliptin with Metformin in Type 2 Diabetes Mellitus: A double and triple drug therapy.

Newly diagnosed males and females with type 2 diabetes mellitus having age between 30 to 55 yrs presenting in diabetic OPD of National Medical Centre Karachi Pakistan.

This clinical trial will be conducted on 135±37=172 newly diagnosed cases of Type 2 Diabetes Mellitus in the National Medical Centre after approval from IRB of Bahria University Health Sciences Campus Karachi. Patients will be enrolled after taking written informed consent. The study design is Randomized open label, parallel arms, clinical trial. They will be randomized into four groups using a sealed envelop method and a non-probability consecutive sampling technique. Total sample size is 135 with 33 patients in each group. However, investigator will work on 172 subjects 43 in each group. Group A will receive fixed drug combination (FDC) of Tab Metforrmin 500mg + Tab Glimepiride 2mg, Group B Tab Metforrmin 500mg + Tab Empagliflozin 12.5mg, Group C Tab Metforrmin 500mg + Tab Sitagliptin 50mg and Group D Tab Metformin 500mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg per orally, once daily for 90 days.

Complete safety profile parameters and analysis, will be done at baseline, week 6 and week 12 in addition to the following:

Baseline= Anthropometric measurements (weight, height, BMI, waist, hip circumference, waist to hip ratio, neck circumference) and all Lab investigation (Glycemic profile including Fasting Blood Sugar, Random Blood Sugar, HbA1c), (Lipid profile TC mg/dL, TG mg/dL, HDL mg/dL, LDL mg/dL, VLDL mg/dL), safety profile (blood (CBC) renal (Serum urea, Serum creatinine, Glomerular Filtration Rate, Urine for Microalbumin) hepatic (Alanine Transaminase, AspartateAminotransferase) and cardiac (Triglycerides, High Density Lipoprotein, Uric Acid).

FBS & RBS on weekly basis Day 45= Anthropometric measurements (weight, height, BMI, waist, hip circumference, waist to hip ratio, neck circumference) and lab investigations (only FBS or RBS) will be done. Adverse events (nausea, vomiting, diarrhea, hypoglycemia, weight gain, constipation, headache, urinary tract infection, flu like symptoms and any others) Day 90= Anthropometric measurements (weight, height, BMI, waist, hip circumference, waist to hip ratio, neck circumference), all Lab investigation (Glycemic profile including Fasting Blood Sugar, Random Blood Sugar, HbA1c), (Lipid profile TC mg/dL, TG mg/dL, HDL mg/dL, LDL mg/dL, VLDL mg/dL), safety profile (blood (CBC) renal (Serum urea, Serum creatinine, Glomerular Filtration Rate, Urine for Microalbumin) hepatic (Alanine Transaminase, AspartateAminotransferase) and cardiac (Triglycerides, High Density Lipoprotein, Uric Acid). Adverse events ( nausea, vomiting, hypoglycemia, weight gain, diarrhea, constipation, headache, urinary tract infection, flu like symptoms and any others)

Individual study period will be 3 months. Total duration of study will be 6 months.

Expected outcome of the study will be:

  1. Clinical Efficacy Evaluation:

    Improvement is expected regarding anthropometric measures such as weight, BMI, hip circumference, and waist circumference, they will be measured to track changes in body composition.

    Assessment of glycemic indicators, including glycated hemoglobin (HbA1c), random blood sugar (RBS), and fasting blood sugar (FBS), in order to gauge progress in glucose regulation.

    To detect any positive changes in lipid levels, lipid profile parameters such as total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides will be done and analyzed.

  2. Comparison of Clinical Efficacy:

    Evaluation of the effects on anthropometric, glycemic, and lipid profile parameters of the effectiveness of four combination treatments (Metformin + Glimepiride, Metformin +Empagliflozin, Metformin + Sitagliptin, and Metformin + Sitagliptin + Empagliflozin). Determination of which drug combination regimen will be better based on the results observed.

  3. Assesment of Adverse Effects:

    Monitoring and recording of side effects, such as genitourinary infections, gastrointestinal symptoms, and other reported side effects, related to each drug combination regimen. A comparison of the various treatment groups' adverse effect rates and severity.

  4. Safety Evaluation:

To ensure the safety of the combination drug regimens, safety profiles will be evaluated using blood parameters, renal function tests, hepatic function tests, and cardiac parameters.

For point #2,3 &4, to come up with a best drug combination regimen for our type2 diabetics.

Study Type

Interventional

Enrollment (Actual)

172

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
    • Sindh
      • Karachi, Sindh, Pakistan, 75500
        • National medical center

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males and females
  • Age 30-55yrs
  • HbA1c = ≥ 8.5 <10 mmol/mol (ADA. 2018)
  • BMI >18.5- <29.9 (WHO Asian Criteria)
  • Treatment naïve patients
  • With / without dyslipidemia.

Exclusion Criteria:

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: Metformin + Glimepiride (Combination Therapy)

Dual therapy (Fixed Dose Combination):

Tab Metformin 500mg + Tab Glimepiride 2mg Dosage: One tablet per day for 90 days.
Drug: Tab Metformin + Tab Glimepiride
Tab Metformin 500mg+ Tab Glimepiride 2mg (FDC) once per orally for 90 days.
Other Names:
  • Tab Orinase-Met (2/500mg)
Active Comparator: Group B: Metformin + Empagliflozin (Combination Therapy)

Dual therapy (Fixed Dose Combination):

Tab Metformin 500mg + Tab Empagliflozin 12.5mg Dosage: One tablet per day for 90 days.
Drug: Tab Metformin + Tab Empagliflozin
Tab Metformin 500mg+Tab Empagliflozin 12.5mg (FDC) once per orally for 90 days.
Other Names:
  • Tab Jardy-Met (12.5/500mg)
Active Comparator: Group C: Metformin + Sitagliptin (Combination Therapy)

Dual therapy (Fixed Dose Combination):

Tab Metformin 500mg + Tab Sitagliptin 50mg Dosage: One tablet per day for 90 days.
Drug: Tab Metformin +Tab Sitagliptin
Tab Metformin 500mg+Tab Sitagliptin 50mg (FDC) once per orally for 90 days.
Other Names:
  • Tab Sita-Met (50/500mg)
Active Comparator: Group D: Metformin + Empagliflozin + Sitagliptin (Combination Therapy)

Triple Therapy:

Tab Metformin 500mg + Tab Empagliflozin 12.5mg (Fixed Dose Combination) + Tab Sitagliptin 50mg Dosage: One tablet of each per day for 90 days.
Drug: Tab Metformin + Tab Empagliflozin + Tab Sitagliptin
Tab Metformin 500mg+Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg once per orally for 90 days.
Other Names:
  • Tab Jardy-Met (12.5/500mg) + Tab Sita 50mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome
Time Frame: 3 months
Change in HbA1c levels in %
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome
Time Frame: 3months
  1. Change in BMI (weight and height will be combined to report BMI in kg/m^2)
  2. Change in Lipid Profile in mg/dL
  3. Incidence of Treatment-Emergent Adverse Events Metformin (Diarrhea) Glimepiride (Weight gain, Hypoglycemia) Empagliflozin (Urinary incontinence, Genitourinary infections) Sitagliptin (Gastrointestinal symptoms, Pancreatitis, Upper respiratory tract infections)
3months

Collaborators and Investigators

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

Sponsor

Bahria University

Investigators

  • Principal Investigator: Saima Chandio, MBBS, Bahria University Islamabad

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.

General Publications

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)

January 1, 2025

Primary Completion (Actual)

March 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

January 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUHS-IRB # R-104/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Data will be shared

IPD Sharing Time Frame

The IPD data will become accessible one year after publication and will remain available indefinitely.

IPD Sharing Access Criteria

All the data will be accessible to everyone.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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