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.
NCT02061969 ↗	ADA Linagliptin in Long Term Care	Completed	American Diabetes Association	Phase 4	2014-04-25	This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.
NCT02061969 ↗	ADA Linagliptin in Long Term Care	Completed	Emory University	Phase 4	2014-04-25	This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.

Clinical Trial Conditions for Tradjenta

Condition Name

Condition Name for Tradjenta
Intervention	Trials
Type 2 Diabetes	4
Diabetes	2
Coronavirus Infection	1
Impaired Renal Function	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
Not yet recruiting	1

Clinical Trial Sponsors for Tradjenta

Sponsor Name

Sponsor Name for Tradjenta
Sponsor	Trials
Emory University	2
University of Miami	1
American Diabetes Association	1

Sponsor Type

Sponsor Type for Tradjenta
Sponsor	Trials
Other	15
Industry	2

TRADJENTA (Linagliptin): Clinical Trials, Market Analysis, and Projections

Introduction to TRADJENTA

TRADJENTA, known generically as linagliptin, is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in the treatment of type 2 diabetes. It is manufactured by Boehringer Ingelheim and marketed in collaboration with Eli Lilly and Company. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials Overview

MARLINA-T2D Trial

One of the significant clinical trials for TRADJENTA is the MARLINA-T2D trial. This study examined the safety and efficacy of TRADJENTA versus placebo in 360 patients with type 2 diabetes and albuminuria (urinary albumin-to-creatinine ratio of 30-3000 mg/g creatinine). The results showed that at 24 weeks, TRADJENTA was associated with a significant 0.6% reduction in A1C (a measure of average blood glucose over the past two to three months) compared to placebo. Although the change in albuminuria was non-significant, TRADJENTA demonstrated a renal safety profile consistent with previous clinical trials[1][3].

Other Clinical Trials

TRADJENTA has been studied in various clinical trials to assess its efficacy and safety in different patient populations. These include studies as monotherapy and in combination with other antihyperglycemic agents such as metformin, sulfonylurea, pioglitazone, and insulin. In these trials, TRADJENTA was generally well-tolerated, with adverse reactions such as upper respiratory tract infections, headache, and cough being more common but not significantly different from placebo in many cases[4].

Pediatric and Renal Impairment Studies

TRADJENTA was also evaluated in a 26-week randomized, double-blind, placebo-controlled trial in pediatric patients aged 10 to 17 years, where its effectiveness was not demonstrated. Additionally, studies in patients with severe renal impairment showed that TRADJENTA did not significantly affect renal function as measured by mean eGFR and creatinine clearance over 52 weeks[4].

Market Analysis

Current Market Position

TRADJENTA has established itself as a key player in the diabetes medication sector, particularly among DPP-4 inhibitors. It is known for its effective glycemic control without weight gain, making it a preferred option for many patients. The drug has been approved by regulatory bodies in the US, Europe, Australia, Canada, Japan, and Korea since 2011[2].

Market Size and Growth

The DPP-4 inhibitors market, which includes TRADJENTA, is projected to reach USD 11.91 billion by 2025 and grow at a CAGR of 2.78% to reach USD 13.66 billion by 2030. The TRADJENTA segment is expected to witness the highest CAGR within this market due to its strong market presence and the impending patent expiration[5].

Patent Expiration and Generic Entry

Patent Expiration Timeline

The molecule patent for linagliptin is set to expire in 2025 in the US, while it will remain active in Europe until May 2033. However, the formulation patent, which is crucial for the launch of generic versions, will expire in November 2027. This timeline suggests that while generic manufacturers can file applications, they cannot launch their products until the formulation patent expires[2].

Impact on Market Dynamics

The expiration of the molecule patent will open up the market to generic versions, potentially increasing accessibility and affordability for patients. However, the delay in the expiration of the formulation patent will give Boehringer Ingelheim some time to maintain its market share before generic competition intensifies. This period will be critical for both the original manufacturer and potential generic entrants as they strategize to capture market share[2].

Market Projections

Increased Accessibility and Affordability

With the entry of generic versions, the market is expected to see a significant increase in accessibility and affordability of linagliptin. This could lead to higher market penetration, especially in regions where cost is a significant barrier to treatment.

Competitive Landscape

The DPP-4 inhibitors market is competitive, with other drugs like Januvia (sitagliptin), Onglyza (saxagliptin), Vipidia (alogliptin), and Galvus (vildagliptin) vying for market share. The entry of generics will further intensify competition, necessitating innovative marketing and pricing strategies from both original and generic manufacturers[5].

Geographic Expansion

The market for TRADJENTA and its generics is expected to grow across various geographies, including North America, Europe, and other regions. The growth will be driven by increasing diabetes prevalence and the need for effective and affordable treatment options[5].

Key Takeaways

• Clinical Efficacy: TRADJENTA has demonstrated significant reductions in A1C levels and a favorable renal safety profile in clinical trials.
• Market Position: It is a key player in the DPP-4 inhibitors market, known for its effectiveness and lack of weight gain.
• Patent Expiration: The molecule patent expires in 2025 in the US, but the formulation patent will remain active until 2027, delaying generic entry.
• Market Growth: The DPP-4 inhibitors market is projected to grow, with TRADJENTA expected to maintain a strong presence despite generic competition.
• Accessibility and Affordability: Generic entry will increase accessibility and affordability, potentially expanding market penetration.

FAQs

What is TRADJENTA used for?

TRADJENTA (linagliptin) is used to improve blood glucose control in adults with type 2 diabetes, often as an adjunct to diet and exercise.

What are the key findings from the MARLINA-T2D trial?

The MARLINA-T2D trial showed that TRADJENTA reduced A1C levels by 0.6% at 24 weeks and had a renal safety profile consistent with previous trials.

When does the patent for TRADJENTA expire?

The molecule patent for linagliptin expires in 2025 in the US, but the formulation patent will expire in November 2027.

How will the entry of generics affect the market?

The entry of generics will increase accessibility and affordability, potentially expanding market penetration, but will also intensify competition in the DPP-4 inhibitors market.

What is the projected market size for DPP-4 inhibitors?

The DPP-4 inhibitors market is projected to reach USD 11.91 billion by 2025 and grow to USD 13.66 billion by 2030.

Sources

1. New study results show Tradjenta® (linagliptin) reduces blood sugar ... - Investor Relations, Eli Lilly and Company.
2. The Trajenta Patent Thicket: Patents expiring in 2025 - GreyB.
3. New study results show Tradjenta® (linagliptin) reduces blood sugar ... - PR Newswire.
4. TRADJENTA® (linagliptin tablets), for oral use - FDA.
5. DPP 4 Inhibitors Market - Share, Size & Industry Analysis - Mordor Intelligence.