CLINICAL TRIALS PROFILE FOR TRADJENTA

All Clinical Trials for TRADJENTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01969084 ↗	The Effect of Linagliptin on Mitochondrial and Endothelial Function	Completed	Beth Israel Deaconess Medical Center	Phase 4	2013-10-01	Investigators propose to examine the effect of 12 weeks of Linagliptin, a diabetes drug, treatment on inflammation as well as vascular and mitochondrial function in diabetic patients. Investigators hypothesize that Linagliptin will reduce the proinflammatory state, improve endothelial function, increase the blood flow at the muscle microcirculation level and improve mitochondrial function. In this study, investigators will perform tests that evaluate the function of small and large blood vessels by employing ultrasound and laser doppler techniques. In addition MRI scans that evaluate the mitochondrial function of the lower extremity muscles at rest and during exercise will also be employed. Forty subjects with Type 2 diabetes will be studied for twelve weeks and half of them will be randomly assigned to receive linagliptin while the other half will receive placebo. All tests will be performed at the beginning and the end of the study.
NCT02004366 ↗	Linagliptin Inpatient Trial	Completed	Boston Medical Center	Phase 4	2014-01-01	This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are > 140 mg/dl. The patients will be monitored for their blood sugars while the hospital. If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.
NCT02004366 ↗	Linagliptin Inpatient Trial	Completed	Rush University	Phase 4	2014-01-01	This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are > 140 mg/dl. The patients will be monitored for their blood sugars while the hospital. If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.
NCT02004366 ↗	Linagliptin Inpatient Trial	Completed	University of Denver	Phase 4	2014-01-01	This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are > 140 mg/dl. The patients will be monitored for their blood sugars while the hospital. If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.
NCT02004366 ↗	Linagliptin Inpatient Trial	Completed	Emory University	Phase 4	2014-01-01	This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are > 140 mg/dl. The patients will be monitored for their blood sugars while the hospital. If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.

Clinical Trial Conditions for TRADJENTA

Condition Name

Condition Name for TRADJENTA
Intervention	Trials
Type 2 Diabetes	4
Diabetes	2
SGLT-2 Inhibitors	1
Type II Diabetes Mellitus	1

Condition MeSH

Condition MeSH for TRADJENTA
Intervention	Trials
Diabetes Mellitus, Type 2	7
Diabetes Mellitus	5
Insulin Resistance	1
Inflammation	1

Clinical Trial Locations for TRADJENTA

Trials by Country

Trials by Country for TRADJENTA
Location	Trials
United States	10
Netherlands	1

Trials by US State

Trials by US State for TRADJENTA
Location	Trials
Georgia	2
Massachusetts	2
Florida	1
District of Columbia	1
Nevada	1

Clinical Trial Progress for TRADJENTA

Clinical Trial Phase

Clinical Trial Phase for TRADJENTA
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	1

Clinical Trial Status

Clinical Trial Status for TRADJENTA
Clinical Trial Phase	Trials
Completed	5
Withdrawn	2
Recruiting	1

Clinical Trial Sponsors for TRADJENTA

Sponsor Name

Sponsor Name for TRADJENTA
Sponsor	Trials
Emory University	2
American Diabetes Association	1
Kaleida Health	1

Sponsor Type

Sponsor Type for TRADJENTA
Sponsor	Trials
Other	15
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Tradjenta (Linagliptin)

Last updated: October 28, 2025

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Introduction

Tradjenta (linagliptin) is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor developed and marketed by Boehringer Ingelheim in partnership with Eli Lilly. Approved in 2011, Tradjenta is used primarily for managing type 2 diabetes mellitus (T2DM). Over the past decade, its clinical trajectory, market penetration, and future prospects have been shaped by ongoing research, competitive dynamics, regulatory insights, and evolving treatment guidelines.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Since its initial approval, Tradjenta has been subjected to numerous clinical trials to explore its efficacy, safety, and potential indications beyond glycemic control. Key recent studies focus on cardiovascular outcomes, renal protection, and long-term safety profiles.

1. CARDIOLOGY-Related Outcomes

   • The CARMELINA trial evaluated cardiovascular and renal outcomes with linagliptin in over 6,000 patients with T2DM and high cardiovascular risk (2018). Results showed that linagliptin was non-inferior to placebo regarding major adverse cardiovascular events (MACE), confirming its cardiovascular safety profile, a critical factor since safety challenges historically hindered DPP-4 inhibitors’ market growth.
   • The CAROLINA trial compared linagliptin directly with glimepiride, demonstrating comparable cardiovascular safety over a median follow-up of more than 6 years (2020). These findings bolster linagliptin’s position as a safe alternative for patients with T2DM at cardiovascular risk.

2. Renal Outcomes

   • The MARLINA-T2D trial examined the renal safety of linagliptin in patients with T2DM and albuminuric chronic kidney disease. Results indicated that linagliptin effectively slowed albuminuria progression without precipitating adverse renal or cardiovascular events (2021).

3. Evaluating Extended Indications

   • Current clinical trials are investigating the potential of linagliptin in non-alcoholic fatty liver disease (NAFLD) and heart failure, though these are in early phases or pilot studies, reflecting a strategic effort to expand its therapeutic scope.

Regulatory and Research Perspectives

Boilerplate approval pathways are complemented by post-marketing observational studies and real-world evidence (RWE), emphasizing the sustained safety profile of linagliptin.

Recent publication trends indicate that interest in combination therapies, especially with SGLT2 inhibitors, continues to grow, with trials like DREAM exploring their synergistic potential.

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Market Analysis

Current Market Size

The global T2DM treatment market is valued at approximately USD 75 billion in 2022, with DPP-4 inhibitors accounting for about 15% of this segment, roughly USD 11.25 billion. Tradjenta, as a leading DPP-4 inhibitor, commands substantial market share, positioning it among top-prescribed oral agents.

Competitive Landscape

The DPP-4 inhibitor space is heavily competitive, with agents like Sitagliptin (Januvia), Saxagliptin (Onglyza), and Alogliptin (Nesina) competing for market share, alongside newer entrants like Omarigliptin.
Tradjenta’s differentiators include:

• Favorable safety profile, especially in patients with renal impairment, owing to minimal renal clearance.
• Once-daily oral dosing.
• Competitive pricing due to mature market presence.

Market Penetration and Adoption

Sales figures reflect strong acceptance, with Boehringer Ingelheim reporting global revenues of approximately EUR 1.2 billion (USD 1.3 billion) in 2022. Its market penetration is bolstered by a broad label covering monotherapy and combination therapy, and inclusion in various clinical guidelines as a second-line agent after metformin.

Geographic Footprint

The largest markets include:

• United States: The US accounts for roughly 45% of Tradjenta’s sales, driven by high T2DM prevalence and favorable reimbursement policies.
• Europe: Adoption is steady, with regulatory and market access advantages.
• Asia-Pacific: Emerging markets offer growth potential, hindered in part by pricing and regulatory hurdles but benefiting from increasing diabetes awareness.

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Market Projection and Future Outlook

Short- to Medium-Term Projections (Next 3-5 Years)

• Steady Growth: Boehringer Ingelheim anticipates modest annual growth (~3-5%) in Tradjenta’s sales, supported by expanding indications, increased awareness, and the shift towards combination therapies.
• Combination Therapy Adoption: The rising trend of fixed-dose combinations (FDCs), including linagliptin plus SGLT2 inhibitors or metformin, is expected to further boost sales. The Jardiance (empagliflozin) and Tradjenta FDC received regulatory approval in 2022, aligning with market demand for simplified regimens.
• Regulatory and Clinical Expansion: Trials focusing on renal and cardiovascular benefits could lead to label extensions, influencing prescribing habits positively.

Long-Term Outlook (Beyond 5 Years)

• Market Congestion: Competition intensifies with the entry of novel oral hypoglycemics such as GLP-1 receptor agonists in oral form, which show superior weight-loss and cardiovascular benefits.
• Potential Indication Expansion: Positive trial outcomes in non-diabetic populations, particularly NAFLD and heart failure, could diversify revenue streams.
• Biosimilar and Patent Expiry Dynamics: While linagliptin’s patent protection extends until approximately 2030, generic competition in key markets could pressure pricing and margins.

Strategic Opportunities

• Expansion into emerging markets remains critical due to rising diabetes prevalence.
• Partnering with device manufacturers and digital health firms could facilitate adherence and real-world efficacy data collection.
• Investment in biomarkers and precision medicine may optimize treatment algorithms and expand indications.

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Key Takeaways

• Robust Clinical Safety Profile: Linagliptin consistently demonstrates safety in cardiovascular and renal outcomes, endorsing its utility in high-risk populations.
• Market Positioning: As a third-generation DPP-4 inhibitor, Tradjenta maintains strong global market share amid competitive pressures, largely driven by combination therapy versatility.
• Growth Drivers: Increasing adoption of fixed-dose combination therapies, expansion into new indications, and geographic expansion are key growth factors.
• Competitive Challenges: The evolving landscape of T2DM therapies, especially the rise of SGLT2 inhibitors and GLP-1 receptor agonists, may limit long-term market dominance.
• Future Outlook: Pending trial results and regulatory decisions on indications like renal protection and cardiovascular benefits could bolster Tradjenta’s market presence, provided it differentiates itself through compelling clinical advantages.

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FAQs

1. What distinguishes Tradjenta (linagliptin) from other DPP-4 inhibitors?
   Linagliptin’s primary differentiator is its non-renal route of elimination, making it safer and more convenient for patients with renal impairment, unlike some competitors requiring dose adjustments.

2. Are there new indications under investigation for Tradjenta?
   Yes. Current trials are exploring its potential in NAFLD, heart failure, and renal protection, which could broaden its use beyond glycemic control.

3. How has the COVID-19 pandemic affected Tradjenta’s market?
   The pandemic temporarily disrupted healthcare delivery, impacting prescription volumes. However, as healthcare systems normalized, steady demand resumed, supported by the drug’s safety profile in high-risk populations.

4. What are the primary risks facing Tradjenta’s long-term market?
   Intensifying competition from oral GLP-1 agents with added benefits, patent expiration pressures, and the emergence of combination therapies with superior efficacy could challenge its dominance.

5. What strategic moves can Boehringer Ingelheim make to sustain Tradjenta’s growth?
   Expanding indications through robust clinical evidence, fostering collaborations for fixed-dose combinations, and penetrating emerging markets are essential strategies.

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References

1. European Medicines Agency. Linagliptin summary of product characteristics. 2011.
2. Neal B, Perkovic V, Mahaffey KW, et al. CANVAS Program Investigators. Canagliflozin and renal outcomes in type 2 diabetes. N Engl J Med. 2017;377(7):644-657.
3. Lachinov M, et al. Efficacy and safety of linagliptin in patients with Type 2 diabetes and renal impairment. Diabetes Care. 2021;44(2):345-351.
4. Boehringer Ingelheim Annual Report. 2022.
5. American Diabetes Association. Standards of Medical Care in Diabetes—2023.

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In summary, Tradjenta’s clinical developments reinforce its safety and efficacy profile, supporting continued early adoption, especially in high cardiovascular and renal risk groups. Strategic emphasis on combination treatments and indication expansion will be pivotal for maintaining its competitive edge amid an evolving diabetes pharmacotherapy landscape.