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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR EMPAGLIFLOZIN; LINAGLIPTIN


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All Clinical Trials for Empagliflozin; Linagliptin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01189201 ↗ Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food Completed Boehringer Ingelheim Phase 1 2010-08-01 The primary objective of the current study is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test) compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference), both in the fasting state. All 42 subjects entered are planned to be included in this comparison. The secondary objective is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet after administration of a standardised high fat, high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the 42 subjects entered 18 subjects are planned to be included in this comparison. An additional objective is to investigate the relative bioavailability of a second formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet (formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned to be included in this comparison.
NCT01422876 ↗ Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients Completed Eli Lilly and Company Phase 3 2011-08-01 This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
NCT01422876 ↗ Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients Completed Boehringer Ingelheim Phase 3 2011-08-01 This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
NCT01734785 ↗ Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes Completed Eli Lilly and Company Phase 3 2013-01-01 This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.
NCT01734785 ↗ Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes Completed Boehringer Ingelheim Phase 3 2013-01-01 This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Empagliflozin; Linagliptin

Condition Name

Condition Name for Empagliflozin; Linagliptin
Intervention Trials
Diabetes Mellitus, Type 2 6
Healthy 6
Kidney Transplant; Complications 2
Diabetes Mellitus 2
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Condition MeSH

Condition MeSH for Empagliflozin; Linagliptin
Intervention Trials
Diabetes Mellitus 11
Diabetes Mellitus, Type 2 10
Insulin Resistance 2
Glucose Intolerance 2
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Clinical Trial Locations for Empagliflozin; Linagliptin

Trials by Country

Trials by Country for Empagliflozin; Linagliptin
Location Trials
United States 83
Canada 14
Australia 9
Germany 9
Brazil 3
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Trials by US State

Trials by US State for Empagliflozin; Linagliptin
Location Trials
Texas 4
North Carolina 4
Michigan 4
Georgia 4
Florida 4
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Clinical Trial Progress for Empagliflozin; Linagliptin

Clinical Trial Phase

Clinical Trial Phase for Empagliflozin; Linagliptin
Clinical Trial Phase Trials
Phase 4 4
Phase 3 8
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Empagliflozin; Linagliptin
Clinical Trial Phase Trials
Completed 13
Recruiting 7
Withdrawn 1
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Clinical Trial Sponsors for Empagliflozin; Linagliptin

Sponsor Name

Sponsor Name for Empagliflozin; Linagliptin
Sponsor Trials
Boehringer Ingelheim 12
Eli Lilly and Company 9
Medanta, The Medicity, India 3
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Sponsor Type

Sponsor Type for Empagliflozin; Linagliptin
Sponsor Trials
Other 22
Industry 22
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Empagliflozin and Linagliptin: Clinical Trials, Market Analysis, and Projections

Introduction

Empagliflozin and linagliptin, when used in a fixed-dose combination (FDC), have emerged as a significant treatment option for type 2 diabetes (T2D). Here, we delve into the clinical trials, market analysis, and future projections for this combination therapy.

Clinical Trials Overview

Approval and Initial Studies

The empagliflozin/linagliptin FDC was approved in Japan in 2018 for the treatment of T2D. Initial phase 3 trials and subsequent post-marketing surveillance studies have provided robust data on its safety and efficacy.

Safety and Efficacy

A one-year, prospective, multicenter, observational study in Japan involving 1146 patients demonstrated that the empagliflozin/linagliptin FDC was effective and generally well tolerated. The study showed significant reductions in body weight, HbA1c, and fasting plasma glucose (FPG) levels. Specifically, the mean changes from baseline were -1.08 kg in body weight, -0.39% in HbA1c, and -7.90 mg/dl in FPG[1][2].

Adverse Drug Reactions

The incidence of adverse drug reactions (ADRs) was low, with only 2.79% of patients experiencing ADRs, and just one serious ADR reported. Common ADRs included urinary tract infections, hypoglycemia, and volume depletion, but no new safety concerns were identified[1][2].

Long-Term Efficacy

A 52-week phase 3 trial comparing different doses of the empagliflozin/linagliptin FDC with monotherapy showed that the combination maintained its efficacy over the entire study period. There were no confirmed hypoglycemic adverse events, and the combination was well tolerated across all groups[4].

Mechanism of Action

Empagliflozin

Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that works by reducing glucose reabsorption in the kidneys, thereby increasing glucose excretion in the urine. It is also indicated to reduce the risk of cardiovascular death and hospitalization due to heart failure in patients with T2D and established cardiovascular disease[3].

Linagliptin

Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases the levels of incretin hormones, enhancing the release of insulin and decreasing the release of glucagon by the pancreas. This action helps to lower blood glucose levels[4].

Market Analysis

Current Market Position

The empagliflozin/linagliptin FDC, marketed under the brand name Glyxambi, has gained traction in several markets, including Japan and Europe. The combination has been approved by regulatory bodies such as the FDA and the EMA, which has facilitated its adoption in clinical practice[5].

Market Trends

The global diabetes market is growing rapidly due to the increasing prevalence of T2D. The demand for combination therapies that offer improved glycemic control with minimal side effects is on the rise. The empagliflozin/linagliptin FDC is well-positioned to capitalize on this trend, given its proven safety and efficacy profile.

Competitive Landscape

The diabetes market is highly competitive, with several combination therapies available. However, the empagliflozin/linagliptin FDC stands out due to its unique mechanism of action and the comprehensive data from clinical trials. It competes with other SGLT2 and DPP-4 inhibitor combinations but has a distinct advantage in terms of cardiovascular and renal benefits associated with empagliflozin[3][5].

Projections and Future Outlook

Market Growth

The global market for the empagliflozin/linagliptin FDC is expected to grow significantly over the next few years. This growth will be driven by the increasing awareness of the benefits of combination therapies in T2D management and the expanding patient population.

Regulatory Approvals

Further regulatory approvals in additional markets are anticipated, which will expand the reach of the empagliflozin/linagliptin FDC. For instance, the FDA approval of an extended-release combination product containing empagliflozin, metformin, and linagliptin in 2020 highlights the ongoing regulatory support for such combination therapies[3].

Clinical Research

Ongoing and future clinical trials will continue to provide valuable data on the long-term safety and efficacy of the empagliflozin/linagliptin FDC. These studies may explore additional indications, such as its use in patients with chronic kidney disease or heart failure, further broadening its therapeutic scope.

Key Takeaways

  • Clinical Efficacy: The empagliflozin/linagliptin FDC has demonstrated significant reductions in HbA1c, FPG, and body weight in clinical trials.
  • Safety Profile: The combination is generally well tolerated with a low incidence of adverse drug reactions.
  • Market Position: The drug is approved in several markets and is gaining traction due to its unique benefits.
  • Future Outlook: The market for this combination therapy is expected to grow, driven by increasing demand for effective T2D treatments and potential additional regulatory approvals.

FAQs

Q: What is the primary mechanism of action of the empagliflozin/linagliptin FDC?

A: Empagliflozin inhibits sodium-glucose co-transporter 2 (SGLT2) to increase glucose excretion, while linagliptin inhibits dipeptidyl peptidase-4 (DPP-4) to enhance insulin release and reduce glucagon levels.

Q: What are the key benefits of the empagliflozin/linagliptin FDC in T2D management?

A: The combination offers improved glycemic control, weight reduction, and a favorable safety profile, including cardiovascular and renal benefits.

Q: Has the empagliflozin/linagliptin FDC been approved by major regulatory bodies?

A: Yes, it has been approved by the FDA, EMA, and other regulatory bodies for the treatment of T2D.

Q: What are the common adverse drug reactions associated with the empagliflozin/linagliptin FDC?

A: Common ADRs include urinary tract infections, hypoglycemia, and volume depletion, but these are relatively rare.

Q: What is the projected market growth for the empagliflozin/linagliptin FDC?

A: The market is expected to grow significantly due to increasing demand for effective combination therapies in T2D management and expanding regulatory approvals.

Sources

  1. Safety and effectiveness of empagliflozin and linagliptin fixed-dose combination in Japanese patients with type 2 diabetes: a post-marketing surveillance study. Tandfonline.
  2. Safety and effectiveness of empagliflozin and linagliptin fixed-dose combination in Japanese patients with type 2 diabetes. PubMed.
  3. Empagliflozin: Uses, Interactions, Mechanism of Action. DrugBank.
  4. Initial Combination of Empagliflozin and Linagliptin in Subjects With Type 2 Diabetes. Diabetes Care.
  5. Glyxambi. European Medicines Agency (EMA).

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