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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR LINAGLIPTIN


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Linagliptin

Condition Name

Condition Name for Linagliptin
Intervention Trials
Diabetes Mellitus, Type 2 51
Healthy 26
Type 2 Diabetes 13
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Condition MeSH

Condition MeSH for Linagliptin
Intervention Trials
Diabetes Mellitus 82
Diabetes Mellitus, Type 2 80
Insulin Resistance 7
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Clinical Trial Locations for Linagliptin

Trials by Country

Trials by Country for Linagliptin
Location Trials
United States 415
Canada 89
Germany 37
Australia 33
Korea, Republic of 25
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Trials by US State

Trials by US State for Linagliptin
Location Trials
Texas 25
Florida 23
California 23
Ohio 18
Georgia 17
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Clinical Trial Progress for Linagliptin

Clinical Trial Phase

Clinical Trial Phase for Linagliptin
Clinical Trial Phase Trials
Phase 4 35
Phase 3 47
Phase 2 8
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Clinical Trial Status

Clinical Trial Status for Linagliptin
Clinical Trial Phase Trials
Completed 103
Recruiting 16
Unknown status 11
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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
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Sponsor Type

Sponsor Type for Linagliptin
Sponsor Trials
Industry 144
Other 95
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Linagliptin: Clinical Trials, Market Analysis, and Projections

Introduction to Linagliptin

Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, a class of drugs used to treat type 2 diabetes mellitus. It works by increasing the levels of incretin hormones, which help control blood sugar levels.

Clinical Trials Update

Linagliptin vs. Standard of Care in COVID-19 and Diabetes

A significant clinical trial investigated the efficacy of linagliptin compared to standard therapy in patients hospitalized with diabetes and COVID-19. This open-label, prospective, multicenter, randomized clinical trial was conducted in three Israeli hospitals between October 2020 and April 2021.

  • Patient Demographics and Outcomes: The trial included 64 patients, with 32 in each group. The primary outcome was the time to clinical improvement within 28 days, defined as a 2-point reduction on an ordinal scale. The results showed no significant difference in the time to clinical improvement between the linagliptin group and the standard of care group, with median times of 7 days and 8 days, respectively[1].
  • Mortality and Adverse Events: In-hospital mortality was 15.6% in the linagliptin group and 25.0% in the standard of care group, though this difference was not statistically significant. Adverse events related to the study drug were rare, with only two patients experiencing hypoglycemia, one in each group[1].
  • Limitations: The trial was prematurely terminated due to the control of the COVID-19 outbreak in Israel, resulting in a small sample size and limited power to detect differences in outcomes[1].

Cardiovascular Outcome Studies

The CAROLINA (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with T2D) trial compared linagliptin with glimepiride in patients with type 2 diabetes.

  • Outcomes: The study found no difference between linagliptin and glimepiride in major adverse cardiovascular events (MACE), overall mortality, cardiovascular mortality, or non-cardiovascular mortality. However, there was a numerically higher hazard ratio for heart failure-related outcomes in the linagliptin group, though this was not statistically significant[4].
  • Additional Studies: Due to regulatory requirements, another cardiovascular outcome study, CARMELINA (CV and Renal Microvascular Outcome Study With Linagliptin), was conducted to compare linagliptin with a placebo as an add-on to standard care. This study aimed to provide more definitive cardiovascular safety data for linagliptin[4].

Market Analysis

Current Market Size and Growth

The linagliptin market is experiencing robust growth driven by increasing demand for effective treatments for type 2 diabetes.

  • Market Size: As of 2023, the global linagliptin market was valued at approximately USD 1008.4 million and is projected to grow to USD 1389.7 million by 2030, with a compound annual growth rate (CAGR) of 4.7%[5].
  • Alternative Projections: Another report suggests a more aggressive growth trajectory, with the market expected to reach USD 200 billion by 2030, growing at a CAGR of 10.41% during the forecast period 2024-2030[5].

Key Players and Market Segmentation

The linagliptin market is characterized by several key players and is segmented based on type, application, and geography.

  • Major Players: Companies such as Honor Lab, EstechPharma, Hangzhou Longshine Bio-Tech, Morepen, Suzhou Bichal Biological Technology, Dr. Reddy’s, and others are prominent in the market. These companies are evaluated based on their product offerings, financial statements, strategic approaches, and geographical presence[5].
  • Market Segmentation: The market is segmented into different types and applications, with regional analyses providing insights into the sales network presence and market footprint of each company[5].

Impact of COVID-19

The COVID-19 pandemic had a significant impact on the linagliptin market, particularly in terms of supply chain disruptions and changes in patient access.

  • Supply Chain Analysis: The pandemic led to assessments of the impact on the supply chain and market size growth rate in various scenarios. Companies had to undertake measures to mitigate these effects and ensure continuous supply and quality of the medication[2].

Projections and Future Outlook

Market Growth Drivers

The growth of the linagliptin market is driven by several factors, including:

  • Increasing Prevalence of Type 2 Diabetes: The rising global incidence of type 2 diabetes is a major driver, as more patients seek effective treatments to manage their condition.
  • Advancements in Pharmaceutical Technology: Continuous research and development in pharmaceuticals lead to improved formulations and manufacturing processes, enhancing the safety, efficacy, and compliance of linagliptin[5].

Challenges and Opportunities

Despite the positive growth projections, the market faces several challenges and opportunities:

  • Regulatory Requirements: The need for large-scale, blinded, placebo-controlled randomized clinical trials to confirm the efficacy and safety of linagliptin in various patient populations remains a significant challenge[1][4].
  • Competitive Landscape: The market is highly competitive, with multiple players vying for market share. Companies must focus on strategic developments, such as new product launches, partnerships, and mergers and acquisitions, to stay competitive[5].

Key Takeaways

  • Clinical Trials: Linagliptin has shown no significant difference in clinical outcomes compared to standard care in patients with diabetes and COVID-19, and similar cardiovascular safety profiles compared to glimepiride.
  • Market Growth: The linagliptin market is expected to grow significantly, driven by increasing demand for type 2 diabetes treatments and advancements in pharmaceutical technology.
  • Key Players: Several major pharmaceutical companies are key players in the market, with a focus on research, development, and strategic market positioning.

FAQs

What is linagliptin used for?

Linagliptin is used to treat type 2 diabetes mellitus by increasing the levels of incretin hormones, which help control blood sugar levels.

What were the findings of the clinical trial comparing linagliptin with standard care in COVID-19 patients?

The trial found no significant difference in the time to clinical improvement between the linagliptin group and the standard of care group, with similar mortality rates and rare adverse events[1].

How is the linagliptin market projected to grow?

The market is projected to grow from USD 1008.4 million in 2023 to USD 1389.7 million by 2030, with a CAGR of 4.7%, or alternatively to USD 200 billion by 2030 with a CAGR of 10.41%[5].

Who are the major players in the linagliptin market?

Major players include Honor Lab, EstechPharma, Hangzhou Longshine Bio-Tech, Morepen, Suzhou Bichal Biological Technology, Dr. Reddy’s, and others[5].

What are the key drivers of the linagliptin market growth?

The growth is driven by the increasing prevalence of type 2 diabetes, advancements in pharmaceutical technology, and strategic market positioning by key players[5].

How did the COVID-19 pandemic impact the linagliptin market?

The pandemic led to supply chain disruptions and changes in patient access, necessitating measures to ensure continuous supply and quality of the medication[2].

Sources

  1. Frontiers in Endocrinology: "A Randomized Clinical Trial of Linagliptin vs. Standard of Care in Hospitalized Patients with Diabetes and COVID-19"[1].
  2. OpenPR: "Linagliptin Market to Witness Robust Expansion by 2025"[2].
  3. FDA: "Statistical Review and Evaluation: Tradjenta (linagliptin), Jentadueto"[3].
  4. Journal of Clinical Pharmacology: "CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with T2D (CAROLINA)"[4].
  5. Verified Market Reports: "Linagliptin Market Trends, Growth Forecast & Analysis"[5].

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