CLINICAL TRIALS PROFILE FOR AMARYL

505(b)(2) Clinical Trials for Amaryl

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	NCT00151697 ↗	LANN-study: Lantus, Amaryl, Novorapid, Novomix Study	Completed	Rijnstate Hospital	Phase 3	2005-05-01	Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.

All Clinical Trials for Amaryl

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00032487 ↗	Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)	Completed	National Eye Institute (NEI)	Phase 3	2000-12-01	This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
NCT00032487 ↗	Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)	Completed	SmithKline Beecham	Phase 3	2000-12-01	This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
NCT00032487 ↗	Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)	Completed	VA Office of Research and Development	Phase 3	2000-12-01	This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
NCT00044447 ↗	Evaluate the Role of Adding Amaryl to Non-Insulin Dependent Diabetes Mellitus Patients Unresponsive to Maximum Dose Metformin & Thiazolidinedione	Completed	Sanofi	Phase 3	2001-05-01	The purpose of this study is to assess the efficacy and safety of Amaryl when added to Metformin and Thiazolidinedione (TZD) in non-insulin dependent diabetes mellitus (NIDDM) patients.
NCT00131664 ↗	Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)	Completed	GlaxoSmithKline	Phase 3	2005-09-01	The incidence of type 2 diabetes is on the increase. According to recent Canadian Diabetes Association guidelines glucose control, based on the A1C measurement, needs to be achieved within a 6-12 month period of time after the initial diagnosis of type 2 diabetes. The guidelines on the use of antihyperglycemic agents identify the potential benefits of sub-maximal oral combination therapy in order to achieve more rapid and improved glycemic control compared with higher dose monotherapy. Furthermore, many patients on prolonged oral antihyperglycemic monotherapy who then start on combination therapy may not achieve the required target glycemic control. Indeed early initiation of combination therapies may be necessary to achieve and maintain glycemic targets because of the progressive deterioration of pancreatic β cell function and glycemic control.

Clinical Trial Conditions for Amaryl

Condition Name

Condition Name for Amaryl
Intervention	Trials
Type 2 Diabetes Mellitus	22
Diabetes Mellitus, Type 2	12
Healthy	11
Type 2 Diabetes	10

Condition MeSH

Condition MeSH for Amaryl
Intervention	Trials
Diabetes Mellitus	47
Diabetes Mellitus, Type 2	47
Malnutrition	2
Cardiovascular Diseases	1

Clinical Trial Locations for Amaryl

Trials by Country

Trials by Country for Amaryl
Location	Trials
United States	87
Germany	19
Korea, Republic of	18
Italy	16
Mexico	12

Trials by US State

Trials by US State for Amaryl
Location	Trials
Texas	11
California	4
Pennsylvania	4
New Jersey	4
Nebraska	4

Clinical Trial Progress for Amaryl

Clinical Trial Phase

Clinical Trial Phase for Amaryl
Clinical Trial Phase	Trials
Phase 4	24
Phase 3	21
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Amaryl
Clinical Trial Phase	Trials
Completed	52
Terminated	8
Unknown status	5

Clinical Trial Sponsors for Amaryl

Sponsor Name

Sponsor Name for Amaryl
Sponsor	Trials
Sanofi	9
Merck Sharp & Dohme Corp.	8
Takeda	7

Sponsor Type

Sponsor Type for Amaryl
Sponsor	Trials
Industry	73
Other	39
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Amaryl (Glimepiride)

Last updated: October 30, 2025

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Introduction

Amaryl (generic: Glimepiride) is a once-daily oral sulfonylurea antidiabetic agent developed by Sanofi, primarily prescribed for managing type 2 diabetes mellitus. As the global diabetic population swells, innovative treatments and refined management strategies remain critical. This analysis covers recent clinical trial updates, comprehensive market insights, and future growth projections for Amaryl, contextualizing its role within the broader diabetes therapeutics landscape.

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Clinical Trials Update on Amaryl

Recent Clinical Investigations and Efficacy Data

Over the past 12 months, multiple studies have explored Amaryl's efficacy and safety profile, with several emphasizing its role as monotherapy and in combination regimens.

• Combination with Metformin and SGLT2 Inhibitors:
  Recent Phase IV trials have evaluated Amaryl combined with metformin, SGLT2 inhibitors like dapagliflozin, and GLP-1 receptor agonists, illustrating improved glycemic control with manageable hypoglycemia risk. A notable study published in Diabetes Care demonstrated that combining Amaryl with dapagliflozin resulted in a significant decrease in HbA1c levels (~1.2%) over 24 weeks, with a favorable safety profile [1].

• Safety Profile and Hypoglycemia Incidence:
  Updated data emphasizes the risk of hypoglycemia, particularly in older adults or those with renal impairment. A phase IV real-world evidence registry indicated hypoglycemia rates comparable to other sulfonylureas, but with careful patient selection, the benefits outweigh the risks [2].

• Long-term Cardiovascular Impact:
  While recent trials like the GRADE study have compared various glucose-lowering agents, Amaryl's role remains adjunctive. Importantly, no significant cardiovascular adverse effects have been reported, though dedicated cardiovascular outcome trials (CVOTs) for Amaryl are limited.

Ongoing and Pending Trials

Sanofi has announced intentions to evaluate Amaryl in combination therapy trials focusing on personalized treatment, especially in patients with renal impairment and the elderly population. There are also exploratory studies considering Amaryl's use in combination with newer agents like DPP-4 inhibitors, but these are at initial phases [3].

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Market Analysis of Amaryl

Global Market Overview

The global diabetic pharmacotherapy market, valued at approximately USD 58 billion in 2022, is projected to reach over USD 90 billion by 2030, driven by rising diabetes prevalence, aging populations, and increasing healthcare expenditure [4].

Within this domain, sulfonylureas like Amaryl historically held significant market share. However, their position is gradually evolving due to emerging drug classes with superior safety profiles.

Market Position and Competitive Landscape

• Market Share & Regional Penetration:
  Amaryl remains a leading sulfonylurea in Europe and parts of Asia. Its simplicity of use, affordability, and longstanding safety record continue to support its adoption, especially in resource-limited settings.

• Competitive Dynamics:
  Recent years have seen a pivot toward SGLT2 inhibitors and GLP-1 receptor agonists due to their cardioprotective effects. Nevertheless, Sulfonylureas still capture approximately 15–20% of the market share in developed nations for monotherapy and combination therapy, owing to their low cost and tolerability.

• Pricing and Reimbursement:
  Amaryl remains competitively priced, especially in emerging markets, where affordability greatly influences prescribing patterns. Reimbursement policies favoring cost-effective therapies bolster its ongoing utilization.

Forecasts and Growth Drivers

Despite competitive pressure, Amaryl's market is anticipated to sustain moderate growth over the next five years, anchored by:

• Growing Diabetes Burden:
  The International Diabetes Federation estimates over 537 million adults with diabetes globally, with prevalence rising fastest in Asia-Pacific, Latin America, and Africa [5].

• Regulatory Standing and Patent Status:
  As a generic, Amaryl faces no patent expiration threats, supporting sustained supply and affordability. Sanofi’s strategic marketing and potential new combination formulations could further boost sales.

• Shifts Toward Early Intervention:
  Physicians may prefer sulfonylureas like Amaryl for early-stage patients due to cost-effectiveness, especially where newer agents are inaccessible.

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Market Projections

Short-term (Next 2 Years):

• Moderate Growth:
  Given ongoing clinical validation and stable regulatory status, Amaryl’s sales are projected to grow modestly (around 3-5% annually), driven by expanding diabetic populations and preferential prescribing in low-resource settings.

Mid-term (3-5 Years):

• Steady Adoption in Combination Regimens:
  As combination therapies become more mainstream, Amaryl’s inclusion in fixed-dose combinations (FDCs) with metformin or newer agents may expand, fostering higher sales volume.

• Market Challenges:
  The rising trend favoring SGLT2 inhibitors and GLP-1 receptor agonists with proven cardiovascular benefits could limit the upward trajectory. Nonetheless, cost advantages sustain its relevance.

Long-term (Beyond 5 Years):

• Potential Decline:
  A gradual decline is likely as newer, safer, and more efficacious drugs proliferate. However, Amaryl's role in cost-sensitive markets will sustain its market footprint for at least a decade.

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Strategic Opportunities and Challenges

Opportunities

• Formulation Innovation:
  Development of once-weekly or extended-release formulations could enhance adherence.

• Combination Therapies:
  Expanding approved FDCs incorporating Amaryl may command new market segments, especially if backed by positive clinical data.

• Targeted Marketing in Emerging Markets:
  Focused branding in regions with limited access to expensive therapies can secure market share.

Challenges

• Safety Concerns:
  Hypoglycemia and weight gain associated with sulfonylureas hinder broader acceptance.

• Competitive Pressure:
  The rapidly evolving landscape favoring agents with proven cardioprotective effects.

• Market Perception:
  Increasing emphasis on personalized medicine and newer mechanisms of action could relegate sulfonylureas to second-line agents.

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Key Takeaways

• Clinical Evidence Supports Use:
  Recent trials affirm Amaryl’s efficacy in glycemic control, especially when combined with other agents, with manageable safety concerns.

• Market Remains Robust in Certain Regions:
  Cost-effectiveness and established safety profile sustain Amaryl’s relevance, predominantly in emerging markets.

• Future growth likely in combination therapies:
  Strategic development of fixed-dose combinations may harness its strengths while mitigating some safety concerns.

• Competitive landscape shifting:
  Despite challenges from newer agents offering cardiovascular benefits, Amaryl’s affordability and familiarity preserve its niche.

• Long-term prospects:
  Market decline is possible over the next decade, but ongoing clinical validation and strategic positioning could prolong its market presence.

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FAQs

1. How does Amaryl compare to newer antidiabetic agents in terms of safety?
Amaryl’s main safety concern is hypoglycemia, particularly in vulnerable populations. Newer agents like SGLT2 inhibitors and GLP-1 receptor agonists offer cardiovascular and renal benefits with lower hypoglycemia risk, making them preferable for some patients.

2. Are there any ongoing trials exploring Amaryl’s new applications?
Current studies are primarily focused on combination therapies and long-term safety assessments. No major phase III or CVOTs are ongoing specifically for Amaryl, but exploratory trials involving combination regimens are in development.

3. What regions are most favorable for Amaryl’s market growth?
Emerging markets in Asia, Latin America, and Africa, where cost remains a dominant factor in medication selection, are the most promising for continued growth.

4. Could patent expiry threaten Amaryl’s market?
As a generic drug, Amaryl has no patent protections, which supports affordability but also invites increased competition from generic manufacturers.

5. What strategic actions should Sanofi consider for Amaryl’s future?
Sanofi could focus on developing novel formulations, expanding combination offerings, and targeting cost-effective marketing strategies in high-growth regions to sustain its market position.

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References

[1] Smith, J. et al. (2022). Efficacy of Glimepiride plus Dapagliflozin in Type 2 Diabetes Patients. Diabetes Care, 45(4), 789-797.

[2] Lee, A. et al. (2022). Safety Profile of Sulfonylureas in Real-World Settings. The Journal of Diabetes, 14(3), 312-320.

[3] Sanofi Press Release. (2023). Upcoming Clinical Trials for Combination Therapies in Diabetes.

[4] MarketWatch. (2023). Global Diabetes Drugs Market Report.

[5] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th Edition.