Type 2 DiabetesPhase 4NCT07311551
A Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus and High Body Mass Index (BMI)
A Phase 4 study testing Dapagliflozin (10Mg Tab) along with standard medical therapy and Empagliflozin (25 Mg Tab) along with standard medical therapy in people with Type 2 Diabetes, run by Bhavya Bhavya, MD.
Trial summary
This study aims to compare the effect of two drugs used to treat diabetes, that is, Dapagliflozin and Empagliflozin on HbA1c (which is an indicator of blood sugar over the last 3 months) body weight, liver and kidney function, blood pressure, and overall cost-effectiveness in patients with type 2 diabetes and high… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dapagliflozin (10Mg Tab) along with standard medical therapy and Empagliflozin (25 Mg Tab) along with standard medical therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 24 Dec 2025to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older with a diagnosis of type 2 diabetes mellitus (T2DM) who have been on stable background therapy for at least three months were eligible for inclusion. Participants were required to have an HbA1c level between 7% and 10% while receiving Metformin with or without other oral hypoglycemic agents, and there had to be a clear clinical indication to initiate an SGLT2 inhibitor. Individuals with a body mass index (BMI) of 23 kg/m² or higher and who were willing to provide written informed consent were included in the study.
Who cannot join
- Patients were excluded if they had uncontrolled diabetes with an HbA1c level greater than 10.0% or if they had used SGLT2 inhibitors, insulin, or GLP-1 receptor agonists within 90 days prior to randomization. Individuals with a history of bariatric surgery or those planning such surgery during the study period were not eligible. Current alcohol consumption of ≥140 g/week in women or ≥210 g/week in men-equivalent to at least 14 or 21 standard drinks per week, respectively-was also an exclusion criterion. Acutely ill patients visiting the OPD, those receiving medications known to cause hepatic steatosis (such as amiodarone, valproate, tamoxifen, methotrexate, or steroids), and individuals with an eGFR <45 mL/min/1.73 m² were excluded. Patients with contraindications to SGLT2 inhibitor use, including a history of recurrent urinary or genital infections, current or previous gangrene, known hypersensitivity to the drug, or a history of diabetic ketoacidosis, were also not included. Pregnant or breastfeeding women were excluded from participation.
About this study
Official title: A Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus and High Body Mass Index (BMI): A Randomized Controlled Trial at a Tertiary Care Hospital in Central India
This study aims to compare the effect of two drugs used to treat diabetes, that is, Dapagliflozin and Empagliflozin on HbA1c (which is an indicator of blood sugar over the last 3 months) body weight, liver and kidney function, blood pressure, and overall cost-effectiveness in patients with type 2 diabetes and high body mass index (23kg/m2). The results will help us determine which drug is more effective, safer, and economical for Indian patients and improve future treatment options.
Read the detailed description
The convergence of India's diabetes epidemic, high rates of obesity and MASLD, and the availability of pleiotropic SGLT2 inhibitors presents both an opportunity and a challenge for optimal diabetes management. While both dapagliflozin and empagliflozin provide significant benefits over and above glycemic control, the absence of direct comparative data in Indian populations limits evidence-based treatment decisions. This study aims to address these critical knowledge gaps by delivering comprehensive comparative effectiveness and cost-effectiveness data to inform clinical practice and healthcare policy in India.
Despite extensive evidence supporting the use of SGLT2 inhibitors, several important knowledge gaps remain, especially in relation to Indian clinical practice.
- Lack of head-to-head comparative data: No Indian randomized controlled trial has directly compared dapagliflozin and empagliflozin in terms of efficacy and safety in patients with type 2 diabetes mellitus (T2DM) and high body mass index.
- Limited data on hepatic outcomes: While individual studies indicate liver benefits, no research has systematically compared the two agents using established hepatic assessment methods such as controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) via transient elastography.
- Population-specific considerations: Indian patients may respond differently to SGLT2 inhibitors due to genetic polymorphisms affecting drug metabolism, distinct body composition patterns, and diverse dietary and lifestyle influences.
- Economic evaluation gaps: There is a lack of comprehensive pharmacoeconomic analyses comparing these agents within the Indian healthcare system, which limits evidence-based formulary choices and reimbursement decisions.
- Real-world effectiveness: While efficacy is proven in controlled trial settings, data on real-world effectiveness in Indian clinical practice conditions remain limited.
This study is uniquely positioned to address this gap by conducting a head-to-head, RCT of dapagliflozin vs. empagliflozin in Indian adults with T2DM and high BMI. The design ensures standardized background therapy, minimizes bias, and includes a comprehensive evaluation of metabolic (HbA1c, weight), hepatic (CAP and LSM), renal, and cardiovascular outcomes, as well as adverse events and patient-reported tolerability. Furthermore, it incorporates a pharmacoeconomic analysis using Average and Incremental Cost-Effectiveness Ratios (ACER, ICER) to assess affordability and value, a key consideration in India and other low- and middle-income countries (LMICs).
By generating robust, context-specific data on comparative efficacy and value of these agents, this study aims to fill a crucial knowledge gap and support personalized clinical decision-making. It is thus expected to make a meaningful contribution to optimizing diabetes care in India.
- Conditions
- Type 2 Diabetes
- Being tested
- Dapagliflozin (10Mg Tab) along with standard medical therapy, Empagliflozin (25 Mg Tab) along with standard medical therapy
- Keywords
- Type 2 diabetes mellitus, MASLD, Overweight, Glycaemic effectivness
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (10Mg Tab) along with standard medical therapyDrug
Group A: Dapagliflozin 10 mg once daily + Metformin ± OHAs
Empagliflozin (25 Mg Tab) along with standard medical therapyDrug
Group B: Empagliflozin 25 mg once daily + Metformin ± OHAs
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Dapagliflozin 10 mg given once daily per orally for 6 months Receives: Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy |
| Group B | Experimental | Empagliflozin 25mg given once daily per orally for 6 months Receives: Drug: Empagliflozin (25 Mg Tab) along with standard medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline at 6 months
Measured: From enrollment to the end of treatment at 6 months
Change in weight from baseline at 6 months
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (14)
Change in HbA1c (%) from baseline at 3 months
Measured: From enrollment to the end of treatment at 3 months
Change in FBG (mg/dL) from baseline at 6 months
Measured: From enrollment to the end of treatment at 6 months
Change in ALT from baseline at 6 months
Measured: From enrollment to the end of treatment at 6 months
Changes in LSM from baseline at 6 months
Measured: From enrollment to the end of treatment at 6 months
Change in SBP (mmHg) from baseline at 6 months
Measured: From enrollment to the end of treatment at 6 months
Change in serum creatinine (mg/dL) from baseline at 6 months
Measured: From enrollment to the end of treatment at 6 months
Incidence of adverse events from baseline at 6 month
Measured: From enrollment to the end of treatment at 6 months
Incidence of Drug-related Discontinuation at 6 month
Measured: From enrollment to the end of treatment at 6 months
Change in AST from baseline at 6 months
Measured: From enrollment to the end of treatment at 6 months
Changes in CAP from baseline at 6 months
Measured: From enrollment to the end of treatment at 6 months
Change in GGT from baseline at 6 months
Measured: From enrollment to 6 months
Change in DBP (mmHg) from baseline at 6 months
Measured: From enrollment to end of treatment at 6 months
Change in eGFR from baseline at 6 months
Measured: From enrollment to end of treatment at 6 months
Change in UACR (mg/g) from baseline at 6 months
Measured: From enrollment to end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start24 Dec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a prospective, randomized, open-label, parallel-group single-centre clinical trial
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bhavya Bhavya, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bhavya Bhavya, MD, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311551
- Sponsor's protocol ID
- Ihecsr/aiimsbpl/July25/213
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus and High Body Mass Index (BMI): A Randomized Controlled Trial at a Tertiary Care Hospital in Central India
- ClinicalTrials.gov ID
- NCT07311551
- Acronym / sponsor ID
- Ihecsr/aiimsbpl/July25/213
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes mellitus, MASLD, Overweight, Glycaemic effectivness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Bhavya Bhavya, MDUniversity, hospital or other
- Study start
- 24 Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effect of two drugs used to treat diabetes, that is, Dapagliflozin and Empagliflozin on HbA1c (which is an indicator of blood sugar over the last 3 months) body weight, liver and kidney function, blood pressure, and overall cost-effectiveness in patients with type 2 diabetes and high body mass index (23kg/m2). The results will help us determine which drug is more effective, safer, and economical for Indian patients and improve future treatment options.
Detailed description
The convergence of India's diabetes epidemic, high rates of obesity and MASLD, and the availability of pleiotropic SGLT2 inhibitors presents both an opportunity and a challenge for optimal diabetes management. While both dapagliflozin and empagliflozin provide significant benefits over and above glycemic control, the absence of direct comparative data in Indian populations limits evidence-based treatment decisions. This study aims to address these critical knowledge gaps by delivering comprehensive comparative effectiveness and cost-effectiveness data to inform clinical practice and healthcare policy in India.
Despite extensive evidence supporting the use of SGLT2 inhibitors, several important knowledge gaps remain, especially in relation to Indian clinical practice.
- Lack of head-to-head comparative data: No Indian randomized controlled trial has directly compared dapagliflozin and empagliflozin in terms of efficacy and safety in patients with type 2 diabetes mellitus (T2DM) and high body mass index.
- Limited data on hepatic outcomes: While individual studies indicate liver benefits, no research has systematically compared the two agents using established hepatic assessment methods such as controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) via transient elastography.
- Population-specific considerations: Indian patients may respond differently to SGLT2 inhibitors due to genetic polymorphisms affecting drug metabolism, distinct body composition patterns, and diverse dietary and lifestyle influences.
- Economic evaluation gaps: There is a lack of comprehensive pharmacoeconomic analyses comparing these agents within the Indian healthcare system, which limits evidence-based formulary choices and reimbursement decisions.
- Real-world effectiveness: While efficacy is proven in controlled trial settings, data on real-world effectiveness in Indian clinical practice conditions remain limited.
This study is uniquely positioned to address this gap by conducting a head-to-head, RCT of dapagliflozin vs. empagliflozin in Indian adults with T2DM and high BMI. The design ensures standardized background therapy, minimizes bias, and includes a comprehensive evaluation of metabolic (HbA1c, weight), hepatic (CAP and LSM), renal, and cardiovascular outcomes, as well as adverse events and patient-reported tolerability. Furthermore, it incorporates a pharmacoeconomic analysis using Average and Incremental Cost-Effectiveness Ratios (ACER, ICER) to assess affordability and value, a key consideration in India and other low- and middle-income countries (LMICs).
By generating robust, context-specific data on comparative efficacy and value of these agents, this study aims to fill a crucial knowledge gap and support personalized clinical decision-making. It is thus expected to make a meaningful contribution to optimizing diabetes care in India.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a prospective, randomized, open-label, parallel-group single-centre clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Dapagliflozin (10Mg Tab) along with standard medical therapyDapagliflozin 10 mg given once daily per orally for 6 months |
| Group B | Experimental | Drug: Empagliflozin (25 Mg Tab) along with standard medical therapyEmpagliflozin 25mg given once daily per orally for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years or older with a diagnosis of type 2 diabetes mellitus (T2DM) who have been on stable background therapy for at least three months were eligible for inclusion. Participants were required to have an HbA1c level between 7% and 10% while receiving Metformin with or without other oral hypoglycemic agents, and there had to be a clear clinical indication to initiate an SGLT2 inhibitor. Individuals with a body mass index (BMI) of 23 kg/m² or higher and who were willing to provide written informed consent were included in the study.
Key exclusion criteria (1 listed)
- Patients were excluded if they had uncontrolled diabetes with an HbA1c level greater than 10.0% or if they had used SGLT2 inhibitors, insulin, or GLP-1 receptor agonists within 90 days prior to randomization. Individuals with a history of bariatric surgery or those planning such surgery during the study period were not eligible. Current alcohol consumption of ≥140 g/week in women or ≥210 g/week in men-equivalent to at least 14 or 21 standard drinks per week, respectively-was also an exclusion criterion. Acutely ill patients visiting the OPD, those receiving medications known to cause hepatic steatosis (such as amiodarone, valproate, tamoxifen, methotrexate, or steroids), and individuals with an eGFR <45 mL/min/1.73 m² were excluded. Patients with contraindications to SGLT2 inhibitor use, including a history of recurrent urinary or genital infections, current or previous gangrene, known hypersensitivity to the drug, or a history of diabetic ketoacidosis, were also not included. Pregnant or breastfeeding women were excluded from participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin (10Mg Tab) along with standard medical therapyGroup A: Dapagliflozin 10 mg once daily + Metformin ± OHAs | Drug | Group A |
| Empagliflozin (25 Mg Tab) along with standard medical therapyGroup B: Empagliflozin 25 mg once daily + Metformin ± OHAs | Drug | Group B |
Primary outcome
Change in HbA1c from baseline at 6 months
Time frame: From enrollment to the end of treatment at 6 months
Change in weight from baseline at 6 months
Time frame: From enrollment to the end of treatment at 6 months
14 secondary outcomes
Change in HbA1c (%) from baseline at 3 months
Time frame: From enrollment to the end of treatment at 3 months
Change in FBG (mg/dL) from baseline at 6 months
Time frame: From enrollment to the end of treatment at 6 months
Change in ALT from baseline at 6 months
Time frame: From enrollment to the end of treatment at 6 months
Changes in LSM from baseline at 6 months
Time frame: From enrollment to the end of treatment at 6 months
Change in SBP (mmHg) from baseline at 6 months
Time frame: From enrollment to the end of treatment at 6 months
Change in serum creatinine (mg/dL) from baseline at 6 months
Time frame: From enrollment to the end of treatment at 6 months
Incidence of adverse events from baseline at 6 month
Time frame: From enrollment to the end of treatment at 6 months
Incidence of Drug-related Discontinuation at 6 month
Time frame: From enrollment to the end of treatment at 6 months
Change in AST from baseline at 6 months
Time frame: From enrollment to the end of treatment at 6 months
Changes in CAP from baseline at 6 months
Time frame: From enrollment to the end of treatment at 6 months
Change in GGT from baseline at 6 months
Time frame: From enrollment to 6 months
Change in DBP (mmHg) from baseline at 6 months
Time frame: From enrollment to end of treatment at 6 months
Change in eGFR from baseline at 6 months
Time frame: From enrollment to end of treatment at 6 months
Change in UACR (mg/g) from baseline at 6 months
Time frame: From enrollment to end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin (10Mg Tab) along with standard medical therapy and Empagliflozin (25 Mg Tab) along with standard medical therapy in people with Type 2 Diabetes, run by Bhavya Bhavya, MD.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from baseline at 6 months (time frame: From enrollment to the end of treatment at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2025.