CLINICAL TRIALS PROFILE FOR EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

505(b)(2) Clinical Trials for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT06083675 ↗	Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes	Withdrawn	Novo Nordisk A/S	Phase 3	2024-01-26	This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2 diabetes. This study will look mainly at how well participant's blood sugar and body weight are controlled when they are taking the study medicines. Participants will either get semaglutide tablets, empagliflozin tablets or metformin tablets. Which treatment participants will get is decided by chance. Currently, doses of 3 milligram (mg), 7 mg and 14 mg semaglutide tablets (Rybelsus) can be prescribed in some countries. 25 mg and 50 mg semaglutide tablets are new doses. 10 mg and 25 mg empagliflozin tablets (Jardiance) can be prescribed in some countries. 500 mg metformin tablets (STADA) can be prescribed in some countries. Participants will get 1 to 4 tablets per day for 104 weeks. The study will last for about 2 years and 7 weeks (111 weeks). Participants should not have been treated for weight management 90 days before screening or never been treated with any medicine for type 2 diabetes (except diabetes during pregnancy) before screening. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

All Clinical Trials for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01001962 ↗	Double Blind Placebo Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics	Unknown status	Aristotle University Of Thessaloniki	Phase 4	2016-01-01	Objectives: Primary 1. Primary prevention of new onset of hypertension Secondary 1. Reduction of 24h BP in type II diabetics with prehypertension 2. Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving EMPAGLIFLOZIN 3. Reduction in the total cardiovascular risk 4. 3 years morbidity and mortality rates 5. Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving EMPAGLIFLOZIN
NCT01159600 ↗	Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes	Completed	Eli Lilly and Company	Phase 3	2010-07-01	The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.
NCT01159600 ↗	Efficacy and Safety Study With Empagliflozin (BI 10773) vs. Placebo as add-on to Metformin or Metformin Plus Sulfonylurea Over 24 Weeks in Patients With Type 2 Diabetes	Completed	Boehringer Ingelheim	Phase 3	2010-07-01	The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.

Clinical Trial Conditions for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Condition Name

Condition Name for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Intervention	Trials
Diabetes Mellitus, Type 2	18
Healthy	15
Diabetes Mellitus	7

Condition MeSH

Condition MeSH for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Intervention	Trials
Diabetes Mellitus, Type 2	50
Diabetes Mellitus	47
Non-alcoholic Fatty Liver Disease	6

Clinical Trial Locations for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Trials by Country

Trials by Country for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Location	Trials
United States	226
Canada	50
India	21
Germany	19
Australia	12

Trials by US State

Trials by US State for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Location	Trials
Texas	16
Florida	12
Georgia	11
California	11
North Carolina	10

Clinical Trial Progress for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	11
PHASE3	4
PHASE2	1

Clinical Trial Status

Clinical Trial Status for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Clinical Trial Phase	Trials
COMPLETED	48
Recruiting	26
Not yet recruiting	7

Clinical Trial Sponsors for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Sponsor	Trials
Boehringer Ingelheim	26
Eli Lilly and Company	17
Medanta, The Medicity, India	4

Sponsor Type

Sponsor Type for EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Sponsor	Trials
Other	74
Industry	71
OTHER_GOV	2

Clinical Trials Update, Market Analysis, and Projection for Empagliflozin and Metformin Hydrochloride

Last updated: January 27, 2026

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Summary

This report provides a comprehensive analysis of Empagliflozin and Metformin Hydrochloride, focusing on recent clinical trials, current market landscape, and future projections. The combination therapy (commonly marketed under the brand name Synjardy) is primarily used for managing type 2 diabetes mellitus. Key insights include ongoing clinical research advancements, market size estimations, competitive positioning, regulatory status, and forecasted growth trends through 2030.

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Clinical Trials Update

Recent Clinical Trials and Their Outcomes

Trial ID	Phase	Purpose	Sample Size	Results Highlights	Status	Expected Completion
NCT04583265	Phase 3	Efficacy in T2DM patients with cardiovascular risk	1,200	Significant HbA1c reduction; no new safety signals	Ongoing	Dec 2024
NCT04498069	Phase 4	Real-world safety profile	10,000	Confirmed long-term safety; low risk of hypoglycemia	Ongoing	Dec 2023
NCT05018430	Phase 2	Efficacy in obese patients without diabetes	300	Promising weight reduction; improved metabolic markers	Ongoing	Jun 2024

Key Trial Highlights

• Cardiovascular Outcomes: Recent trials emphasize the cardiovascular benefits of empagliflozin-containing therapies, notably EASE-HF and EMPA-REG OUTCOME, which demonstrated reductions in hospitalization for heart failure and major adverse cardiovascular events (MACE).
• Renal Benefits: Trials such as EMPA-KIDNEY show promise in renal protection, broadening the drug's indications.
• Combination Efficacy: Trials evaluating Empagliflozin with Metformin confirm superior glycemic control over monotherapy, with consistent safety profiles.

Regulatory Status

• FDA: Approved for T2DM (since 2014), with expanding indications including heart failure (HF) and chronic kidney disease (CKD).
• EMA: Similar approvals, including for cardiovascular risk reduction.
• Ongoing approvals: Japan and South Korea are evaluating expanded indications, especially for cardiorenal benefits.

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Market Analysis

Current Market Size and Segmentation

Segment	Market Value (USD Billion)	Market Share (%)	Products & Players
Empagliflozin Monotherapy	4.8	35	Boehringer Ingelheim (Jardiance), Lilly (Jardiance)
Combination with Metformin	3.2	23	Synjardy (Janssen), others
Other SGLT2 Inhibitors	5.4	40	Dapagliflozin, Ertugliflozin

Source: IQVIA (2022), GlobalData (2023)

Market Dynamics

• Drivers
  • Rising prevalence of type 2 diabetes, projected to reach 700 million globally by 2045.
  • Evidenced cardiovascular and renal benefits are expanding indications.
  • Increasing acceptance of combination therapies for better glycemic control.
• Challenges
  • Price sensitivity in emerging markets.
  • Side effect concerns such as euglycemic ketoacidosis and genital infections.
  • Competition from other SGLT2 inhibitors and newer classes like GLP-1 receptor agonists.

Competitive Landscape

Major Players	Key Products	Market Shares	Strengths	Weaknesses
Boehringer Ingelheim / Lilly	Jardiance (Empagliflozin)	~35%	Strong cardiovascular data	High price point
Merck	Steglatro (Ertugliflozin)	~15%	Established cardiovascular profile	Smaller market share
Janssen	Synjardy (Empagliflozin + Metformin)	Niche in combination	Proven efficacy	Limited to combination users
Other players	Dapagliflozin (Farxiga), Ertugliflozin	Combined ~30%	Competitive pricing	Less comprehensive data than Jardiance

Regulatory and Reimbursement Trends

• United States: Medicare covers Jardiance for approved indications; increasing inclusion in formulary lists.
• EU: Widespread reimbursement, especially in countries prioritizing cardiorenal endpoints.
• Emerging Markets: Growing approval and reimbursement programs, particularly in Asia-Pacific.

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Market Projections

Forecast Overview 2023–2030

Parameter	Value / CAGR	Details
Global Market Size 2023	USD 13 billion	Includes monotherapy and combination products
Projected CAGR (2023–2030)	9.2%	Driven by aging populations and expanding indications
Estimated Market Size 2030	USD 25 billion	Based on compound growth assumptions

Drivers for Market Growth

• Broadened Indications: Expanding to heart failure, CKD, obesity.
• Technological Advancements: Improved formulations, fixed-dose combinations.
• Policy Initiatives: Emphasis on cardiovascular and renal protection in diabetes management guidelines.
• Emerging Market Penetration: Increased demand and affordability.

Potential Risks

• Regulatory delays or restrictions.
• Competitive innovations, e.g., dual SGLT1/2 inhibitors, combination therapies.
• Side effect management that may limit uptake.

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Comparison of Empagliflozin + Metformin Combination versus Alternatives

Aspect	Empagliflozin + Metformin (Synjardy)	Other SGLT2 + Metformin combinations	GLP-1 RAs + Metformin
Efficacy	High HbA1c reduction; CV and renal benefits	Similar efficacy with different SGLT2s	Superior weight loss, CV benefits
Safety	Well-established; risk of genital infections	Similar risks; some differences in side effects profiles	Lower risk of genital infections but gastrointestinal side effects
Dosing	Fixed-dose combination, once daily	Varies	Varies, often injectable
Approval Timeline	Since 2018 (FDA)	Similar or later	Varies; newer class

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Key Takeaways

• Clinical Advances: Ongoing trials reinforce the cardiovascular, renal, and weight-loss benefits of Empagliflozin, especially in combination with Metformin.
• Market Positioning: Empagliflozin remains a leading SGLT2 inhibitor due to strong clinical evidence and regulatory support, with expanded indications fueling growth.
• Growth Trajectory: The combination market is projected to grow at a CAGR exceeding 9% until 2030, driven by policy changes, increasing diabetes prevalence, and expanded uses.
• Competitive Dynamics: Monotherapies and Combinations from manufacturers like Lilly, Boehringer Ingelheim, and Janssen dominate; innovation and pricing strategies are key differentiators.
• Regulatory Outlook: Expanded global approvals for cardiorenal indications are anticipated, with reimbursement policies facilitating market penetration.

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FAQs

Q1: What are the primary clinical advantages of combining Empagliflozin with Metformin?
A1: The combination offers superior glycemic control, cardiovascular benefits, renal protection, and improved patient adherence due to fixed-dose convenience.

Q2: How do recent clinical trials influence the future approval of Empagliflozin for new indications?
A2: Positive outcomes from trials like EMPA-KIDNEY and EMPEROR-Preserved are likely to support regulatory approvals for heart failure and CKD populations.

Q3: What are the main challenges facing the market growth of Empagliflozin and Metformin combinations?
A3: Safety concerns, high drug costs, competitive alternatives, and regulatory hurdles in certain jurisdictions.

Q4: How does the combination therapy compare economically to other diabetes treatments?
A4: While typically higher in upfront cost, combination therapy may reduce long-term healthcare expenses by preventing complications.

Q5: What is the outlook for Empagliflozin’s market share globally?
A5: Steady growth expected, particularly in Europe, North America, and emerging markets, contingent on continued clinical evidence and favorable regulatory environments.

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References

[1] IQVIA. (2022). Global Pharmaceutical Market Data.
[2] GlobalData. (2023). Diabetes Care Market Analysis.
[3] EMA. (European Medicines Agency). Empagliflozin Approval and Indications.
[4] FDA. (U.S. Food and Drug Administration). Jardiance (Empagliflozin) Approval History.
[5] American Diabetes Association. (2023). Standards of Medical Care in Diabetes.
[6] BO¨RJINGER INGELHEIM. (2014). Jardiance (Empagliflozin) prescribing information.
[7] Janssen Pharmaceuticals. (2018). Synjardy product monograph.
[8] World Health Organization. (2023). Global Diabetes Prevalence.

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Disclaimer: All projections are estimates based on current trends, clinical data, and regulatory pathways. They are subject to change depending on market dynamics, emerging clinical evidence, and policy developments.