A Phase 4 interventional study of Metformin+ Empagliflozin + Sitagliptin and Metformin + Empagliflozin + Linagliptin in Type 2 Diabetes Mellitus, sponsored by Bahria University. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 30 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Bahria University · Phase 4, Interventional, and Treatment
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.
To evaluate and compare The Comparative Efficacy and Safety of Metformin-Empagliflozin-Sitagliptin vs. Metformin-Empagliflozin-Linagliptin as Initial Triple Therapy in Type 2 Diabetes Mellitus.
Newly diagnosed males and females with type 2 diabetes mellitus having age between 30 to 55 years presenting in diabetic OPD of National Medical Centre Karachi Pakistan.
This clinical trial will be conducted on 94+16=110 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 two groups using a sealed enveloped method and a non-probability consecutive sampling technique. Total sample size is 94 with 47 patients in each group. However, investigator will work on 110 subjects 55 in each group. 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.
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 investigations (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, Aspartate Aminotransferase), 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 (hypoglycemia, nausea, vomiting, diarrhea, constipation, headache, weight gain, 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), and all lab investigations (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, Aspartate Aminotransferase), and Cardiac (Triglycerides, High Density Lipoprotein, Uric Acid). Adverse events (hypoglycemia, nausea, vomiting, diarrhea, constipation, headache, weight gain, urinary tract infection, flu-like symptoms and any others).
Expected outcomes of the study will be :
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 level, lipid profile parameters such as total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides will be done and analyzed.
Comparison of Clinical Efficacy:
Evaluation of the effects on anthropometric, glycemic, and lipid profile parameters of of the effectiveness of two combination treatments (Metformin + Empagliflozin + Sitagliptin vs. Metformin + Empagliflozin + Linagliptin).
Determination of which drug combination regimen will be better based on the results observed.
Assessment 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 various treatment group's adverse effect rates and severity.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 110 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Bahria University is the lead sponsor of 36 studies on the registry; 11 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metformin decrease hepatic production of glucose. Empagliflozin increase urinary glucose excretion. Sitagliptin increase glucose dependent insulin release.
Drug: Metformin+ Empagliflozin + Sitagliptin
Metformin reduces hepatic glucose production. Empagliflozin raise excretion of urinary glucose. Sitagliptin increase glucose dependent insulin release.
Drug: Metformin + Empagliflozin + Linagliptin
Drug pages: Metformin · Empagliflozin · Sitagliptin
Group A (Triple Therapy): Tab Metformin 1000mg + Tab Empagliflozin 12.5mg (FDC) + Tab Sitagliptin 50mg, orally, once daily for 90 days
Drug pages: Metformin · Empagliflozin · Linagliptin
Group B (Triple Therapy) Tab Metformin 1000mg + Tab Empagliflozin 12.5mg + Tab Linagliptin 2.5mg (FDC) orally, once daily, for 90 days.
Primary Outcome
Change in HbA1c levels in %
Time frame: 3 Months
Secondary Outcome : changes in weight from baseline to 12 weeks (kg)
the study will measure percentage change in weight from baseline to 12 weeks and proportion of participants achieving weight loss 1- 3 kg as national institute of health. Time Frame: 12 weeks
Time frame: 12 weeks
Secondary Outcome: changes in BMI from baseline to 12 weeks (kg/m²).
The study will measure percentage changes in BMI from baseline to 12 weeks and proportion of participants achieving required BMI
Time frame: 12 weeks
Secondary outcome: changes in lipid profile (TC, TG, HDL, LDL, VLDL) from baseline to 12 weeks (mg/dl)
The study will measure the changes in lipid profiles level from baseline to 12 weeks to evaluate the efficacy of triple vs initial triple therapy
Time frame: 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
The study will measure the safety of Adverse Effects (nausea, vomiting, diarrhea, constipation, UTIs, flu like symptoms, headache, hypoglycemia, weight gain) from baseline to 12 weeks to evaluate the safety of triple vs initial triple therapy
Time frame: 12 weeks
Plan to share: No
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Studies of the drugs tested here: Metformin · Empagliflozin · Sitagliptin · Linagliptin
Bahria University