CLINICAL TRIALS PROFILE FOR INSULIN GLARGINE; LIXISENATIDE

All Clinical Trials for Insulin Glargine; Lixisenatide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00975286 ↗	24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine	Completed	Sanofi	Phase 3	2009-10-01	The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment. The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24. The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (
NCT01146678 ↗	Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1	Completed	Sanofi	Phase 1	2010-06-01	Primary Objective: - to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug Secondary Objectives: - to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug - to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix
NCT01476475 ↗	Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients	Completed	Sanofi	Phase 2	2011-11-01	Primary Objective: - The purpose of this study was to compare insulin glargine/ lixisenatide fixed ratio combination (FRC) versus insulin glargine on glycemic control over 24 weeks, as evaluated by glycosylated hemoglobin (HbA1c) reduction in type 2 diabetic participants treated with metformin. Secondary Objectives: - To compare insulin glargine/lixisenatide FRC versus insulin glargine over 24 weeks on: - Glycemic control in relation to a meal as evaluated by post-prandial plasma glucose and glucose excursions during a standardized meal test; - Percentage of participants reaching HbA1c
NCT01596504 ↗	Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin	Completed	Sanofi	Phase 2	2012-05-01	Primary Objective: - To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily (QD) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after a standardized breakfast at the end of a 8-week treatment period in participants with type 2 diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin). Secondary Objectives: - To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8 mg QD after an 8-week treatment period in participants with T2DM not adequately controlled with insulin glargine (± metformin) on: - Post-prandial C-peptide, glucagon and appetite perceptions after a standardized breakfast, - Appetite perceptions after standardized dinner, - Gastric emptying after a standardized labelled test meal, - Fasting plasma glucose, 24-hour plasma glucose profile, - Glycosylated hemoglobin (HbA1c), - Insulin glargine dose, - 7-point self monitored plasma glucose (SMPG), - Body weight and waist circumference, - 24-hour heart rate and blood pressure, - To assess lixisenatide and liraglutide safety and tolerability as add on treatment to insulin glargine (± metformin).
NCT01768559 ↗	Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients	Completed	Sanofi	Phase 3	2013-01-01	Primary Objective: - To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin. Secondary Objectives: - To compare the treatments/regimens on: - The percentage of participants reaching the target of HbA1c
NCT01910194 ↗	Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying	Completed	Sanofi	Phase 2	2013-12-01	Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying
NCT01910194 ↗	Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying	Completed	Profil Institut für Stoffwechselforschung GmbH	Phase 2	2013-12-01	Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying

Clinical Trial Conditions for Insulin Glargine; Lixisenatide

Condition Name

Condition Name for Insulin Glargine; Lixisenatide
Intervention	Trials
Type 2 Diabetes Mellitus	15
Type 2 Diabetes	5
Diabetes Mellitus	2
Steroid-Induced Hyperglycemia	1

Condition MeSH

Condition MeSH for Insulin Glargine; Lixisenatide
Intervention	Trials
Diabetes Mellitus, Type 2	23
Diabetes Mellitus	22
Hypoglycemia	1
Hyperglycemia	1

Clinical Trial Locations for Insulin Glargine; Lixisenatide

Trials by Country

Trials by Country for Insulin Glargine; Lixisenatide
Location	Trials
United States	151
Germany	9
Romania	6
Canada	6
Poland	6

Trials by US State

Trials by US State for Insulin Glargine; Lixisenatide
Location	Trials
Maryland	6
California	6
Texas	6
Pennsylvania	6
Florida	5

Clinical Trial Progress for Insulin Glargine; Lixisenatide

Clinical Trial Phase

Clinical Trial Phase for Insulin Glargine; Lixisenatide
Clinical Trial Phase	Trials
PHASE4	4
Phase 4	4
Phase 3	14

Clinical Trial Status

Clinical Trial Status for Insulin Glargine; Lixisenatide
Clinical Trial Phase	Trials
Completed	20
ENROLLING_BY_INVITATION	2
RECRUITING	2

Clinical Trial Sponsors for Insulin Glargine; Lixisenatide

Sponsor Name

Sponsor Name for Insulin Glargine; Lixisenatide
Sponsor	Trials
Sanofi	19
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	1
Profil Institut für Stoffwechselforschung GmbH	1

Sponsor Type

Sponsor Type for Insulin Glargine; Lixisenatide
Sponsor	Trials
Industry	20
Other	8

Clinical Trials Update, Market Analysis, and Projection for Insulin Glargine and Lixisenatide

Last updated: October 30, 2025

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Introduction

The global diabetes therapeutics market witnesses rapid innovation, driven by the rising prevalence of diabetes mellitus, particularly Type 2 diabetes (T2D). Two prominent drugs—Insulin Glargine and Lixisenatide—have secured significant market share due to their efficacy in glucose control. This analysis offers a comprehensive update on their ongoing clinical trials, market dynamics, and future projections, serving as an essential guide for stakeholders.

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Clinical Trials Update

Insulin Glargine

Insulin Glargine, a long-acting basal insulin analog, remains a cornerstone in diabetes management. Recent clinical trials focus on its safety, efficacy, and potential for improved administration.

• Innovations and New Formulations:
  Novo Nordisk, the originator, continues to explore enhanced delivery mechanisms, including concentrated formulations (e.g., U300). An ongoing Phase III trial (NCT05266824) evaluates its efficacy and safety in pediatric populations, aiming to expand indications.

• Comparative Effectiveness Trials:
  Multiple head-to-head studies compare Insulin Glargine U300 with other basal insulins such as insulin degludec and insulin detemir. For instance, the "DISPEL" trial compares glycemic stability and hypoglycemia risk across insulins, with preliminary results indicating comparable efficacy but reduced hypoglycemia with U300.

• Biosimilar Development:
  Several biosimilars, including Fiasp, are in late-phase clinical development, emphasizing cost-effective options without compromising quality.

Lixisenatide

A GLP-1 receptor agonist, Lixisenatide's clinical trials primarily address cardiovascular risk reduction, weight management, and combination therapies.

• Cardiovascular Outcomes:
  The ORIGIN trial and subsequent studies (e.g., ELIXA) demonstrated CV safety but did not conclusively show superiority. Nonetheless, recent Phase III trials (e.g., REWIND) assessing long-term CV benefits are ongoing, with initial data suggesting potential cardioprotective effects.

• Fixed-Dose Combinations:
  Trials are exploring Lixisenatide combined with basal insulins (e.g., insulin glargine), aiming to improve adherence and glycemic control. The "LixiLan" series has demonstrated positive outcomes in T2D management.

• Extended-release Formulations:
  Investigational extended-release formulations aim to enhance patient convenience, with two Phase II trials examining pharmacokinetics and tolerability.

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Market Dynamics and Key Actors

Market Size and Growth Drivers

The global diabetes therapeutics market, valued at approximately USD 86 billion in 2021, is projected to grow at a CAGR of 6-8% through 2028, driven by increasing prevalence, aging populations, and innovations in treatment modalities.

• Insulin Glargine
  Dominates basal insulin market, representing approximately 45-50% of total insulin sales globally (~USD 25 billion in 2022). North America and Europe account for substantial shares owing to high diagnosis rates and reimbursement policies.

• Lixisenatide
  Positioned within GLP-1 receptor agonist class, with a market share of about 12-15%. Its primary markets include North America, Europe, and select Asia-Pacific countries.

Competitive Landscape

• Major Companies:
  Novo Nordisk maintains the leadership position with Insulin Glargine products (Lantus, Tresiba), followed by Eli Lilly’s Humulin, and Sanofi’s biosimilars.
  Lixisenatide competes with drugs like liraglutide (Victoza), semaglutide (Ozempic), and dulaglutide (Trulicity) from Eli Lilly and Novo Nordisk.

• Biosimilars and Generics:
  The entry of biosimilars is pressuring prices, especially in Europe and emerging markets, expanding access.

• Regulatory and Policy Impact:
  Heightened emphasis on value-based care and affordability is incentivizing biosimilar adoption and innovation in formulation.

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Market Projection

Forecast for Insulin Glargine

By 2030, the Insulin Glargine segment is expected to reach approximately USD 55-60 billion, reflecting:

• Continued Innovation:
  Enhanced formulations with improved pharmacokinetics, reduced hypoglycemia, and user-friendly devices.

• Expanding Indications:
  Usage in Type 1 and Type 2 diabetes, along with potential application in managing insulin resistance syndromes.

• Emerging Markets:
  Rapidly increasing adoption in Asia-Pacific and Latin America, supported by market expansion and pricing strategies.

Forecast for Lixisenatide

The GLP-1 receptor agonist market, including Lixisenatide, is projected to grow from USD 7 billion in 2022 to approximately USD 15-20 billion by 2030, owing to:

• Long-term Cardiovascular Benefits:
  Growing evidence supports CV benefits, expanding indications, and prescription rates.

• Combination Therapies:
  Increased use of fixed-dose combinations with basal insulins and other agents improves adherence and outcomes.

• Regulatory Approvals:
  Approvals for once-weekly formulations and injectable pens could significantly boost market penetration.

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Strategic Implications

• Innovation & Differentiation:
  Companies investing in formulations that offer better safety profiles, convenience, and cost-effectiveness will shape market dynamics.

• Regulatory & Reimbursement Policies:
  Favoring biosimilar entry and value-based care models will pressure incumbent brands but also open access.

• Geographic Expansion:
  Emerging markets provide significant growth opportunities, contingent upon pricing strategies and local healthcare infrastructure.

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Key Takeaways

• Robust Clinical Pipeline:
  Both Insulin Glargine and Lixisenatide are undergoing pivotal trials aimed at improving safety, efficacy, and patient adherence.

• Market Leadership & Competition:
  Novo Nordisk dominates by leveraging continuous innovation, while biosimilar proliferation intensifies price competition.

• Growth Trajectory:
  The insulin market will sustain strong growth through innovation and expanding indications, while GLP-1 therapies, including Lixisenatide, will benefit from demonstrated cardiovascular benefits.

• Emerging Market Opportunities:
  Asia-Pacific and Latin America are strategic targets due to rising diabetes prevalence and increasing healthcare access.

• Regulatory Trend & Adoption:
  Evidence supporting long-term safety and efficacy influences physician prescribing behaviors and reimbursement policies.

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FAQs

1. What are the latest developments in clinical trials for Insulin Glargine?
   Recent trials focus on enhanced formulations (e.g., U300), pediatric safety, and head-to-head efficacy studies, confirming its position as a long-acting basal insulin with a robust safety profile.

2. How does Lixisenatide compare with other GLP-1 receptor agonists in cardiovascular outcomes?
   While early trials (ELIXA) demonstrated safety, ongoing studies (REWIND) suggest potential cardioprotective benefits, making it an attractive option for T2D patients with cardiovascular risks.

3. What are the key market drivers for Insulin Glargine?
   Advancements in formulations, expanding indications, biosimilar availability, and growing global diabetes prevalence are primary drivers.

4. What factors could impact the growth projections of Lixisenatide?
   Competition from longer-acting GLP-1s, patient preferences for less frequent dosing, and regulatory approvals will influence its market share.

5. What is the outlook for biosimilar insulin products?
   Biosimilars are expected to gain significant market share, reducing costs and increasing access, especially in regions with cost sensitivity.

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References

1. [1] International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.
2. [2] Novo Nordisk Annual Report 2022.
3. [3] ClinicalTrials.gov. Various ongoing clinical trials on insulin glargine and lixisenatide.
4. [4] MarketsandMarkets. Diabetes Care Market Forecast, 2021-2028.
5. [5] European Medicines Agency. Biosimilar Insulins Overview, 2022.