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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR LINAGLIPTIN; METFORMIN HYDROCHLORIDE


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All Clinical Trials for Linagliptin; Metformin Hydrochloride

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.
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.
NCT00798161 ↗ Safety and Efficacy of Linagliptin (BI 1356) Plus Metformin in Type 2 Diabetes, Factorial Design Completed Boehringer Ingelheim Phase 3 2008-12-01 The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks
NCT00915772 ↗ Treatment of Type 2 Diabetes With Linagliptin 2.5 mg Bid + Metformin 500 or 1000 mg Bid and Metformin 1000 mg Bid Completed Boehringer Ingelheim Phase 3 2009-06-01 A phase III randomised, double-blind parallel group extension study to investigate the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg versus monotherapy with metformin 1000 mg twice daily over 54 weeks in type 2 diabetic patients previously completing the double-blind part of study 1218.46
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Linagliptin; Metformin Hydrochloride

Condition Name

Condition Name for Linagliptin; Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus, Type 2 22
Healthy 16
Prediabetic State 4
Insulin Resistance 4
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Condition MeSH

Condition MeSH for Linagliptin; Metformin Hydrochloride
Intervention Trials
Diabetes Mellitus 34
Diabetes Mellitus, Type 2 31
Insulin Resistance 6
Prediabetic State 5
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Clinical Trial Locations for Linagliptin; Metformin Hydrochloride

Trials by Country

Trials by Country for Linagliptin; Metformin Hydrochloride
Location Trials
United States 146
Canada 47
Germany 19
Australia 16
Mexico 12
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Trials by US State

Trials by US State for Linagliptin; Metformin Hydrochloride
Location Trials
Texas 9
Georgia 8
Florida 8
California 8
Ohio 7
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Clinical Trial Progress for Linagliptin; Metformin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Linagliptin; Metformin Hydrochloride
Clinical Trial Phase Trials
Phase 4 15
Phase 3 18
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Linagliptin; Metformin Hydrochloride
Clinical Trial Phase Trials
Completed 43
Recruiting 10
Unknown status 7
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Clinical Trial Sponsors for Linagliptin; Metformin Hydrochloride

Sponsor Name

Sponsor Name for Linagliptin; Metformin Hydrochloride
Sponsor Trials
Boehringer Ingelheim 38
Eli Lilly and Company 19
Hospital Regional de Alta Especialidad del Bajio 4
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Sponsor Type

Sponsor Type for Linagliptin; Metformin Hydrochloride
Sponsor Trials
Industry 67
Other 45
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Linagliptin and Metformin Hydrochloride: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Linagliptin and metformin hydrochloride, a combination therapy for Type 2 Diabetes Mellitus (T2DM), has been a significant focus in the pharmaceutical industry due to its efficacy in glycemic control. This article delves into the recent clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Overview

Bioequivalence and Efficacy Studies

Clinical trials have been conducted to establish the bioequivalence and efficacy of linagliptin and metformin hydrochloride combination tablets. A notable study involved a randomized, open-label, two-period, two-sequence crossover design to compare the bioequivalence of a fixed-dose combination (FDC) tablet of empagliflozin/linagliptin/metformin extended release with the free combination of these drugs. This study aimed to ensure that the FDC tablet is as effective as the individual components administered separately[1].

Another significant study was a 24-week, randomized, double-blind trial that evaluated the efficacy and safety of linagliptin co-administered with metformin in treatment-naive adults with T2DM. The results showed that the combination therapy significantly reduced A1C levels and fasting plasma glucose (FPG) compared to linagliptin alone[3].

Phase 3 Studies

Phase 3 studies, such as those referenced in the FDA's review of the triple FDC (empagliflozin, linagliptin, and metformin HCl), have supported the efficacy and safety of linagliptin and metformin combination therapy. These studies demonstrated that the combination was superior in reducing HbA1c, FPG, and body weight when compared to monotherapies on a metformin background therapy[4].

Mechanism of Action

Linagliptin

Linagliptin works by inhibiting the enzyme dipeptidyl peptidase-4 (DPP-4), which increases the levels of incretin hormones. These hormones enhance the release of insulin and decrease the release of glucagon, thereby improving glucose regulation[5].

Metformin Hydrochloride

Metformin decreases hepatic glucose production and increases insulin sensitivity, which helps in lowering blood glucose levels. When combined with linagliptin, it enhances the overall glycemic control by targeting different pathways of glucose metabolism[2].

Market Analysis

Market Drivers

The market for linagliptin and metformin hydrochloride tablets is driven by several key factors:

  • Rising Prevalence of Diabetes: The increasing global incidence of T2DM creates a significant demand for effective diabetes management solutions.
  • Healthcare Sector Advancements: Continuous advancements in healthcare technologies and treatments favor the adoption of combination therapies.
  • Patient Adherence: Combining two potent agents into a single tablet enhances patient compliance, which is a critical factor in diabetes management[2].

Market Restraints

Despite the positive drivers, there are several challenges:

  • Potential Side Effects: Anticipated side effects and safety concerns can impede market growth.
  • Regulatory Hurdles: Stringent approval processes and regulatory requirements can slow down market entry.
  • Price Sensitivity: In emerging economies, price sensitivity and the availability of alternative treatments pose additional challenges[2].

Competitive Landscape

The competitive landscape is characterized by market share analysis, strategic approaches, and product range of key industry players. The report highlights that identifying niches in pharmacies and potential in geriatric populations appreciating combination therapy are crucial for market expansion[2].

Market Projections

Market Penetration and Development

The market is expected to grow as it penetrates deeper into emerging markets and expands in mature segments. Detailed data from key industry players indicate potential growth prospects, especially in regions with high diabetes prevalence[2].

Market Diversification

Recent product launches, untapped geographic regions, and strategic investments are expected to drive market diversification. The report emphasizes the importance of recent industry developments and advancements in manufacturing capabilities of leading market players[2].

Product Development and Innovation

Upcoming technologies and research and development efforts are likely to introduce new innovations in the linagliptin and metformin hydrochloride market. Notable advancements in product innovation will continue to shape the market landscape[2].

Key Takeaways

  • Clinical Efficacy: Linagliptin and metformin hydrochloride combination therapy has demonstrated significant efficacy in reducing A1C levels and FPG in clinical trials.
  • Market Growth: The market is driven by the rising prevalence of diabetes, healthcare advancements, and improved patient adherence.
  • Challenges: Potential side effects, regulatory hurdles, and price sensitivity in emerging economies are key challenges.
  • Future Prospects: Market expansion is expected through deeper penetration into emerging markets, diversification, and continuous product innovation.

FAQs

Q: What is the primary mechanism of action of linagliptin in combination with metformin?

A: Linagliptin inhibits the DPP-4 enzyme, increasing incretin levels and enhancing insulin secretion, while metformin decreases hepatic glucose production and increases insulin sensitivity[5].

Q: What were the key findings of the 24-week clinical trial on linagliptin and metformin combination therapy?

A: The trial showed that the combination therapy reduced A1C levels by 2.9% and FPG levels significantly compared to linagliptin alone, with a greater percentage of patients achieving an A1C less than 7%[3].

Q: What are the main market drivers for linagliptin and metformin hydrochloride tablets?

A: The main drivers include the rising prevalence of diabetes, healthcare sector advancements, and improved patient adherence through combination therapy[2].

Q: What challenges might impede the market growth of linagliptin and metformin hydrochloride tablets?

A: Potential side effects, regulatory hurdles, price sensitivity in emerging economies, and market saturation with existing diabetes medications are key challenges[2].

Q: How is the competitive landscape of the linagliptin and metformin hydrochloride market characterized?

A: The competitive landscape includes market share analysis, strategic approaches, product range, and certifications of key industry players, as well as identifying niches in pharmacies and potential in geriatric populations[2].

Sources

  1. Clinical Trial Protocol - Boehringer Ingelheim, "Bioequivalence of a low strength fixed dose combination tablet of empagliflozin/linagliptin/metformin extended release compared to the free combination of empagliflozin, linagliptin, and metformin extended release tablets"[1].
  2. Market Research Report - 360iResearch, "Linagliptin & Metformin Hydrochloride Tablets Market"[2].
  3. Clinical Trial Data - Eli Lilly and Company, "Type 2 diabetes: Jentadueto® (linagliptin and metformin) tablets now includes clinical trial data"[3].
  4. FDA Review - FDA, "New Drug Application (NDA) for Trijardy XR (Empagliflozin, linagliptin, and metformin HCl extended-release)"[4].
  5. Clinical Pharmacology Review - FDA, "Relative BA study to evaluate the effect of food on the pharmacokinetics of linagliptin and metformin from the intended (fixed-dose) combination formulation"[5].

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