CLINICAL TRIALS PROFILE FOR LINAGLIPTIN

505(b)(2) Clinical Trials for linagliptin

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 Combination	NCT05641337 ↗	Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes	Recruiting	Huashan Hospital	Phase 3	2022-10-01	Poor blood glucose control in liver cirrhosis can aggravate the poor prognosis of patients. Under the background of the increasing number of liver cirrhosis patients with metabolic abnormalities, how to optimize treatment is particularly important. The traditional treatment of diabetes at the stage of liver cirrhosis is limited to insulin intensive therapy, but the incidence of hypoglycemia is high, blood sugar fluctuates greatly, and multiple injections are required. Research shows that insulin therapy has an increased overall mortality compared with non insulin therapy. We used metformin,Ryzodeg and an oral DDP IV enzyme inhibitor as the core combination according to the special pathological mechanism of elevated blood glucose in liver cirrhosis . After preliminary experiments, we found that the program was stable and was not easy to have hypoglycemia, and there was no traditional risk of lactic acid poisoning caused by metformin. We designed an open randomized controlled clinical study, Compared with the traditional insulin intensive treatment scheme, this new combination scheme was compared whether it could improve the blood glucose level, the incidence of hypoglycemia and lactic acid level, the incidence of cirrhosis complications, and the long-term survival rate of liver disease. This study is helpful to optimize the hypoglycemic treatment of cirrhosis with diabetes, and improve the blood glucose and long-term prognosis, The positive evidence of this study contributes to the consensus or guidelines for the treatment of cirrhosis with diabetes.

All Clinical Trials for linagliptin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00309608 ↗	Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes	Completed	Boehringer Ingelheim	Phase 2	2006-04-01	The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.
NCT00328172 ↗	Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients	Completed	Boehringer Ingelheim	Phase 2	2006-05-01	The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.
NCT00601250 ↗	Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes	Completed	Boehringer Ingelheim	Phase 3	2008-01-01	The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
NCT00602472 ↗	BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes	Completed	Boehringer Ingelheim	Phase 3	2008-02-01	The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.
NCT00621140 ↗	Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control	Completed	Boehringer Ingelheim	Phase 3	2008-02-01	To investigate efficacy, safety and tolerability of BI 1356 versus placebo
NCT00641043 ↗	Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone	Completed	Boehringer Ingelheim	Phase 3	2008-03-01	The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.
NCT00654381 ↗	Japanese P III vs Voglibose and Placebo	Completed	Boehringer Ingelheim	Phase 3	2008-04-01	The objective of the current study is to investigate the efficacy, safety and tolerability of Linagliptin (BI 1356) (5 mg or 10 mg / once daily) compared to placebo given for 12 weeks and voglibose for 26 weeks as mono therapy in patients with type 2 diabetes mellitus with insufficient glycaemic control. Furthermore, long-term safety is evaluated with an extension treatment to 52 weeks.

Clinical Trial Conditions for linagliptin

Condition Name

Condition Name for linagliptin
Intervention	Trials
Diabetes Mellitus, Type 2	51
Healthy	26
Type 2 Diabetes	13
Type 2 Diabetes Mellitus	10

Condition MeSH

Condition MeSH for linagliptin
Intervention	Trials
Diabetes Mellitus, Type 2	85
Diabetes Mellitus	82
Insulin Resistance	7
Renal Insufficiency	7

Clinical Trial Locations for linagliptin

Trials by Country

Trials by Country for linagliptin
Location	Trials
United States	415
Canada	89
Germany	37
Australia	33
China	27

Trials by US State

Trials by US State for linagliptin
Location	Trials
Texas	25
Florida	23
California	23
Ohio	18
Georgia	17

Clinical Trial Progress for linagliptin

Clinical Trial Phase

Clinical Trial Phase for linagliptin
Clinical Trial Phase	Trials
PHASE4	3
PHASE1	6
Phase 4	35

Clinical Trial Status

Clinical Trial Status for linagliptin
Clinical Trial Phase	Trials
Completed	106
Recruiting	18
Unknown status	11

Clinical Trial Sponsors for linagliptin

Sponsor Name

Sponsor Name for linagliptin
Sponsor	Trials
Boehringer Ingelheim	75
Eli Lilly and Company	36
Hospital Regional de Alta Especialidad del Bajio	5

Sponsor Type

Sponsor Type for linagliptin
Sponsor	Trials
Industry	149
Other	103
NETWORK	1

Clinical Trials Update, Market Analysis, and Projection for Linagliptin

Last updated: October 28, 2025

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Introduction

Linagliptin, marketed under the brand name Tradjenta among others, is a dipeptidyl peptidase-4 (DPP-4) inhibitor used primarily for managing type 2 diabetes mellitus (T2DM). Developed by Boehringer Ingelheim, linagliptin has established itself as a key pharmacological agent owing to its unique pharmacokinetic profile. This report provides an updated review of clinical trial developments, market dynamics, and future projections for linagliptin, offering vital insights for stakeholders and investors in the pharmaceutical landscape.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Recent years have seen an intensified focus on expanding linagliptin's therapeutic profile. Several ongoing clinical trials aim to explore its efficacy beyond glycemic control, including effects on cardiovascular outcomes, renal protection, and combination therapies.

• Cardiovascular Safety Trials: The cardiovascular (CV) safety profile of linagliptin has been well documented with post-approval studies like the CARMELINA trial. Launched in 2016, CARMELINA evaluated CV outcomes and renal safety in a high-risk T2DM population, confirming the drug's CV safety but not demonstrating superiority over placebo in reducing CV events [1].

• Renal Outcomes and Benefits: The ongoing MARLINA-T2D trial investigates whether linagliptin can improve renal biomarkers and slow disease progression in patients with T2DM and early-stage diabetic kidney disease. Preliminary data suggest potential nephroprotective effects, although definitive results await publication.

• Combination Regimen Trials: Several studies are assessing linagliptin's efficacy when combined with agents such as SGLT2 inhibitors and GLP-1 receptor agonists. These trials aim to refine combination therapy guidelines, considering the persistent challenge of achieving optimal glycemic targets.

Novel Indications and Expanded Uses

Besides T2DM, linagliptin is under investigational review for its potential in treating non-alcoholic fatty liver disease (NAFLD), given DPP-4’s role in inflammation and fibrogenesis. Early-phase trials explore its impact on liver inflammation and insulin sensitivity, though conclusive data are pending.

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Market Dynamics and Competitive Landscape

Current Market Position

Linagliptin's market position is reinforced by its once-daily oral administration and minimal renal dose adjustments, making it preferable for elderly and comorbid patients with renal impairment. As of 2022, linagliptin held approximately 15% of the global DPP-4 inhibitor market, valued at approximately $3.2 billion, according to IQVIA data.

Key Market Drivers

• Growing Prevalence of T2DM: The global T2DM population exceeds 537 million and is projected to reach 700 million by 2045 [2]. This demographic trend drives demand for effective, well-tolerated oral antidiabetics like linagliptin.

• Advantages Over Competing Agents: Linagliptin’s unique pharmacokinetics—primarily non-renal clearance—positions it favorably over other DPP-4 inhibitors, especially in patients with renal impairment. Its once-daily dosing enhances adherence.

• Combination Therapies: Increasing approval of fixed-dose combinations (FDCs), such as linagliptin with empagliflozin, broadens its utility and appeal among clinicians.

Competitive Landscape

Major competitors include sitagliptin (Merck), saxagliptin (AstraZeneca), and alogliptin (Takeda). While all share similar mechanisms, linagliptin's non-renal dosing advantage gives it competitive leverage.

• Increased Patent Expiry Risks: Wholesale generic availability is anticipated post-patent expiry, expected around 2027. However, ongoing patent litigation and formulation patents may extend exclusivity in certain jurisdictions.

• Emerging Class of Drugs: The advent of SGLT2 inhibitors and GLP-1 receptor agonists providing cardio- and renoprotective effects pressures linagliptin’s market share, necessitating strategic emphasis on specialty indications and combination therapies.

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Market Projections

Future Revenue Forecasts

Analysts project the linagliptin market to experience a Compound Annual Growth Rate (CAGR) of 5-7% over the next five years, driven by increasing global T2DM prevalence, expanding therapeutic applications, and durable brand recognition. By 2028, the global market for linagliptin and its combinations could surpass $5 billion, with North America and Europe contributing about 60% of revenue.

Emerging Markets and Access Expansion

Growth opportunities are substantial in emerging economies like India, Brazil, and Southeast Asia, where rising T2DM rates coincide with increasing healthcare infrastructure investments. Price sensitivity and patent expiries, however, may influence uptake.

Innovation and Pipeline Development

Despite its longstanding presence, linagliptin’s future heavily relies on ongoing clinical trials demonstrating additional benefits—particularly in renal and cardiovascular protection. Positive outcomes could lead to regulatory approvals for expanded indications, further supporting revenue streams.

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Regulatory Considerations and Strategic Outlook

The FDA and EMA continue to emphasize the importance of CV safety in antidiabetic drugs, a criterion linagliptin has already met. Future regulatory pathways for combination therapies and expanded indications remain promising, provided trial data substantiates clinical benefits.

Boehringer Ingelheim’s strategic focus on positioning linagliptin within personalized treatment regimens and combination therapies will underpin its market longevity. Furthermore, partnerships with biosimilar and generic manufacturers may influence pricing and accessibility, shaping competitive dynamics.

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Key Takeaways

• Clinical Promise Continues: Ongoing studies are exploring linagliptin’s nephroprotective and potential extra-glycemic benefits, which may diversify its therapeutic profile.

• Market Stability with Growth Potential: Despite intensifying competition, linagliptin maintains a stronghold owing to its pharmacokinetic advantages, particularly for patients with renal impairment.

• Future Revenue Streams: The combination therapy market and emerging indications are critical growth vectors, with projections indicating a multibillion-dollar opportunity by 2028.

• Regulatory and Patent Landscape: Patents expiring around 2027 may introduce generic competition, but novel formulations and additional indications can extend brand exclusivity.

• Strategic Considerations: Collaboration, pipeline expansion, and geographic diversification will be essential for maintaining market relevance amid evolving therapeutic standards.

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FAQs

1. What are the primary clinical advantages of linagliptin over other DPP-4 inhibitors?
Linagliptin’s non-renal clearance allows it to be used without dose adjustment in patients with renal impairment, a significant advantage over competitors requiring renal dose modifications.

2. Are there any ongoing trials that could expand linagliptin’s approved uses?
Yes, trials like MARLINA-T2D and studies investigating renal and cardiovascular outcomes could support label extensions into renoprotection and cardioprotection, broadening its therapeutic scope.

3. How does the patent landscape impact linagliptin’s market prospects?
Patents are expected to expire around 2027, which could lead to generic competition. However, formulation patents and combination therapy patents may extend market exclusivity in certain regions.

4. What role do combination therapies play in linagliptin’s market strategy?
Combination therapies enhance adherence, provide multi-pathway management, and are increasingly favored in guidelines, which bolsters linagliptin’s market presence and revenue potential.

5. What are the key factors influencing linagliptin’s future growth?
Growth hinges on clinical trial outcomes, expanding indications, strategic partnerships, patent protections, and the ability to differentiate amid a competitive landscape increasingly adopting newer drug classes.

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References

1. Rosenstock J, et al. “Effect of linagliptin on cardiovascular and renal outcomes in patients with type 2 diabetes: The CARMELINA trial.” The New England Journal of Medicine, 2019.
2. International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.