CLINICAL TRIALS PROFILE FOR JARDIANCE

505(b)(2) Clinical Trials for JARDIANCE

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↗	Research Study to Compare Semaglutide Tablets With Empagliflozin or Metformin Tablets in People With Type 2 Diabetes	Withdrawn	Novo Nordisk A/S	Phase 3	2024-01-26	This study compares the medicines semaglutide with empagliflozin or metformin in people with newly diagnosed type 2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 JARDIANCE

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
NCT02401880 ↗	Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology	Completed	Profil Institut für Stoffwechselforschung GmbH	Phase 4	2015-05-01	The primary aim of this exploratory mechanistic study is to investigate the effects of Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients. This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell function, as well as several markers of metabolic control.
NCT02367131 ↗	Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus	Completed	Eli Lilly and Company		2015-02-24	Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.
NCT02367131 ↗	Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus	Completed	Boehringer Ingelheim		2015-02-24	Study to investigate the safety and efficacy of daily use of JARDIANCE® Tablets in Japanese elderly patients with type 2 diabetes mellitus.

Clinical Trial Conditions for JARDIANCE

Condition Name

Condition Name for JARDIANCE
Intervention	Trials
Diabetes Mellitus, Type 2	10
Type 2 Diabetes	6
Type 2 Diabetes Mellitus	6
Type2 Diabetes	5

Condition MeSH

Condition MeSH for JARDIANCE
Intervention	Trials
Diabetes Mellitus	33
Diabetes Mellitus, Type 2	32
Kidney Diseases	8
Heart Failure	7

Clinical Trial Locations for JARDIANCE

Trials by Country

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Trials by Country for JARDIANCE
Location	Trials
United States	23
India	16
Poland	10
Austria	8
Germany	8

Trials by US State

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−

Trials by US State for JARDIANCE
Location	Trials
Texas	4
New York	3
Minnesota	3
Ohio	2
Tennessee	1

Clinical Trial Progress for JARDIANCE

Clinical Trial Phase

Clinical Trial Phase for JARDIANCE
Clinical Trial Phase	Trials
Phase 4	27
Phase 3	13
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for JARDIANCE
Clinical Trial Phase	Trials
Completed	28
Not yet recruiting	15
Recruiting	14

Clinical Trial Sponsors for JARDIANCE

Sponsor Name

Sponsor Name for JARDIANCE
Sponsor	Trials
Boehringer Ingelheim	16
Eli Lilly and Company	4
University Hospital, Basel, Switzerland	3

Sponsor Type

Sponsor Type for JARDIANCE
Sponsor	Trials
Other	116
Industry	30
NIH	3

Jardiance (Empagliflozin): Clinical Trials, Market Analysis, and Projections

Introduction to Jardiance

Jardiance, also known as empagliflozin, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor used primarily in the treatment of type 2 diabetes. It has also shown significant benefits in reducing cardiovascular risks and is increasingly recognized for its role in treating heart failure.

Clinical Trials Overview

FDA Approval and Initial Trials

The FDA approval of Jardiance was based on two Phase III clinical trials. One trial evaluated Jardiance as a monotherapy against a placebo, while the other assessed its efficacy in combination with other diabetes medications such as metformin, sulfonylurea, pioglitazone, and insulin. These trials demonstrated a significant reduction in hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes[1].

Cardiovascular Benefits

A key finding from these trials was a 38% decrease in deaths from cardiovascular disease and a 32% decrease in overall mortality in patients receiving Jardiance compared to those receiving a placebo over 3.1 years. This trial also showed that Jardiance extended the lifespan of patients with type 2 diabetes and cardiovascular disease by one to four and a half years[1].

Heart Failure Trials

The EMPEROR-Preserved and EMPEROR-Reduced phase III trials further highlighted Jardiance's benefits. The EMPEROR-Preserved trial demonstrated that Jardiance significantly reduced the composite risk of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction (HFpEF). This makes Jardiance the first and only clinically proven therapy to improve outcomes for the full spectrum of heart failure patients, including both HFpEF and heart failure with reduced ejection fraction (HFrEF)[4].

Recent Clinical Findings

The EMPACT-MI phase 3 clinical trial showed a 10% risk reduction in hospitalized heart failure patients after using Jardiance. This positive result is expected to boost demand for the drug in the coming years[3].

Adverse Effects and Safety Profile

While Jardiance has shown significant clinical benefits, it also comes with several adverse effects. Common side effects include urinary tract infections, vaginal yeast infections, and hypoglycemia when used in combination with sulfonylurea or insulin. Other reported side effects are physical weakness, headaches, confusion, hunger, drowsiness, sweating, kidney problems, and a rise in cholesterol levels[1].

Market Analysis

Current Market Size and Share

The global SGLT2 inhibitors market, dominated by Jardiance, was estimated at USD 15.85 billion in 2023. Jardiance accounted for 52.60% of the global revenue in this segment and is anticipated to grow significantly over the forecast period[3].

Market Forecast and Growth

The SGLT2 inhibitors market, led by Jardiance, is projected to grow at a compound annual growth rate (CAGR) of 7.71% from 2024 to 2030. This growth is driven by the drug's efficacy in treating type 2 diabetes and its expanding role in cardiovascular and heart failure treatments[3].

Competitive Landscape

Jardiance is a key contender in the myocardial infarction treatment sector, with a comprehensive market forecast and detailed analysis highlighting its competitive environment. The report from ResearchAndMarkets.com provides insights into the current and future competitive landscape, including emerging therapies that may rival Jardiance's position[2].

Regulatory Milestones

In September 2023, the U.S. FDA approved Jardiance for its ability to reduce the risk of cardiovascular mortality and chronic kidney disease (CKD) hospitalization. Additionally, Jardiance has been included in the “Drug Price Negotiation Program” as part of the Inflation Reduction Act (IRA), which is expected to drive segment growth[3].

Market Projections

Sales Trajectory

The market forecast for Jardiance indicates a strong sales trajectory, with prospective sales forecasting in key markets embracing innovation in myocardial infarction therapy. The report from ResearchAndMarkets.com provides a detailed analysis of the expected sales trajectory up to 2032[2].

Geographical Trends

The global Empagliflozin Jardiance market report provides an analysis of geographical trends, segmenting the market into types, applications, and regional insights. This analysis helps in understanding the key industry segments and their global, regional, and country-level insights[5].

Emerging Opportunities

The market analysis highlights emerging opportunities and market evolution. With Jardiance continuing to carve out a significant place in treating myocardial infarction and heart failure, healthcare providers and industry leaders are poised to capitalize on its full potential and market derivatives in the coming decade[2].

Key Takeaways

• Clinical Efficacy: Jardiance has demonstrated significant reductions in cardiovascular deaths and overall mortality in patients with type 2 diabetes and cardiovascular disease.
• Heart Failure Treatment: Jardiance is the first and only clinically proven therapy to improve outcomes for the full spectrum of heart failure patients.
• Market Dominance: Jardiance dominates the SGLT2 inhibitors market, accounting for 52.60% of global revenue in 2023.
• Growth Projections: The market is projected to grow at a CAGR of 7.71% from 2024 to 2030.
• Regulatory Approvals: Recent FDA approvals and inclusion in the “Drug Price Negotiation Program” are expected to drive segment growth.

FAQs

What is Jardiance used for?

Jardiance, or empagliflozin, is primarily used for the treatment of type 2 diabetes. It also has significant benefits in reducing cardiovascular risks and is used in treating heart failure.

What were the key findings from the clinical trials of Jardiance?

Clinical trials showed a 38% decrease in deaths from cardiovascular disease and a 32% decrease in overall mortality. Jardiance also extended the lifespan of patients with type 2 diabetes and cardiovascular disease by one to four and a half years.

How does Jardiance impact heart failure treatment?

Jardiance is the first and only clinically proven therapy to improve outcomes for the full spectrum of heart failure patients, including both heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF).

What is the current market size and growth projection for Jardiance?

The global SGLT2 inhibitors market, dominated by Jardiance, was estimated at USD 15.85 billion in 2023 and is projected to grow at a CAGR of 7.71% from 2024 to 2030.

What are the common adverse effects of Jardiance?

Common adverse effects include urinary tract infections, vaginal yeast infections, hypoglycemia (when used with sulfonylurea or insulin), physical weakness, headaches, confusion, hunger, drowsiness, sweating, kidney problems, and a rise in cholesterol levels.

Sources

1. Clinical trials of Jardiance: Clinical trials arena, "Jardiance for the Treatment of Type 2 Diabetes, US", October 27, 2023.
2. JARDIANCE Market Forecast: GlobeNewswire, "JARDIANCE (Empagliflozin) Market Forecast Reveals Major Role in Myocardial Infarction Treatment and Competitive Landscape Analysis Through 2032", February 28, 2024.
3. SGLT2 Inhibitors Market Report: Grand View Research, "SGLT2 Inhibitors Market Size, Share & Growth Report, 2030".
4. Breakthrough results for Jardiance: Eli Lilly and Company, "Breakthrough results for Jardiance® (empagliflozin) confirm EMPEROR-Preserved as first and only successful trial for heart failure with preserved ejection fraction".
5. Empagliflozin Jardiance Market Report: Cognitive Market Research, "Empagliflozin Jardiance Market Report 2024 (Global Edition)", December 10, 2024.