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.
NCT00131664 ↗	Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)	Completed	Canadian Heart Research Centre	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.
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.

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
Disease	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
Illinois	4
California	4
Pennsylvania	4
New Jersey	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

Amaryl (Glimepiride): Clinical Trials, Market Analysis, and Projections

Introduction to Amaryl (Glimepiride)

Amaryl, known generically as glimepiride, is a sulfonylurea used in the treatment of type 2 diabetes. It works by stimulating the pancreas to release insulin, thus helping to lower blood sugar levels.

Clinical Trials and Efficacy

Recent Studies

A significant clinical trial investigated the combination of glimepiride with linagliptin, a dipeptidyl peptidase 4 inhibitor. This study, conducted from September 2017 to June 2019, aimed to evaluate the efficacy and safety of this combination versus glimepiride monotherapy. The trial was approved by relevant authorities and adhered to international guidelines for good clinical practice[4].

The results of such studies are crucial in understanding the therapeutic benefits and potential side effects of glimepiride when used alone or in combination with other diabetes medications.

Safety and Efficacy Profile

Glimepiride has a well-established safety and efficacy profile. It is known for its high bioavailability (100%) and extensive protein binding (>99.5%), which contributes to its effectiveness in managing blood glucose levels. The drug has an onset of action within 2-3 hours, an elimination half-life of 5-8 hours, and a duration of action of 24 hours[1].

Market Analysis

Current Market Size and Growth

The sulfonylureas market, which includes Amaryl, is projected to reach USD 9.98 billion in 2024 and grow at a CAGR of 3.12% to reach USD 11.32 billion by 2029. This growth is driven by the increasing prevalence of diabetes globally and the critical role sulfonylureas play in diabetes management[2].

Regional Market Dynamics

• North America: This region holds the largest market share in the sulfonylureas market, driven by high diagnosis and treatment rates for diabetes.
• Middle East and Africa: This region is expected to witness the highest CAGR over the forecast period, primarily due to the alarming increase in diabetes prevalence and improving healthcare access.
• Asia-Pacific: Countries like China and India are driving growth in this region due to large patient populations and increasing access to healthcare[2][5].

Competitive Landscape

The market for glimepiride is moderately competitive, with key players including Sanofi Aventis, Pfizer Inc., Merck & Co., Inc., Torrent Pharma, and Dr. Reddy's Laboratories. These companies are focusing on strategies such as new product launches, geographical expansion, and collaborations to strengthen their market positions. For example, Sanofi launched a new fixed-dose combination of glimepiride and metformin in the U.S. market under the brand name Amaryl M in 2021[2][5].

Market Projections

Global Glimepiride Dispersible Tablet Market

The global glimepiride dispersible tablet market is expected to reach a value of over $1 billion by 2025, growing at a CAGR of around 5% during the forecast period. This growth is driven by the increasing global prevalence of type 2 diabetes, aging populations, rising obesity rates, and the advantages of dispersible tablets for ease of administration[5].

Emerging Markets

Emerging markets such as Latin America and the Middle East & Africa offer significant growth potential due to large diabetic populations and improving healthcare infrastructure. However, these regions also face challenges like limited healthcare infrastructure and high out-of-pocket expenses for medicines[5].

Advanced Formulations and Drug Delivery Systems

The market is seeing a trend towards the development of advanced formulations and drug delivery systems to improve efficacy and patient compliance. For instance, Novartis AG launched a novel formulation of glimepiride under the brand name Zigpride in India in 2019[5].

Impact of COVID-19

The COVID-19 pandemic has had a substantial impact on the sulfonylureas market. The increased prevalence of diabetes in patients hospitalized with COVID-19 and the recognition that improved glycemic control can improve outcomes have underscored the importance of oral anti-diabetic drugs like glimepiride. This has led to an increased demand for sulfonylureas globally[2].

Key Takeaways

• Clinical Efficacy: Glimepiride has a well-established efficacy profile, especially when combined with other diabetes medications.
• Market Growth: The sulfonylureas market, including Amaryl, is expected to grow at a CAGR of 3.12% from 2024 to 2029.
• Regional Dynamics: North America holds the largest market share, while the Middle East and Africa region is expected to witness the highest CAGR.
• Competitive Landscape: The market is moderately competitive with key players focusing on new product launches and geographical expansion.
• Emerging Markets: Latin America and the Middle East & Africa offer significant growth potential.
• COVID-19 Impact: The pandemic has increased the demand for sulfonylureas due to the critical role they play in managing diabetes in COVID-19 patients.

FAQs

What is the current market size of the sulfonylureas market?

The sulfonylureas market size is expected to reach USD 9.98 billion in 2024[2].

Which region has the largest share in the sulfonylureas market?

North America accounts for the largest market share in the sulfonylureas market[2].

What is the expected CAGR of the sulfonylureas market from 2024 to 2029?

The sulfonylureas market is expected to grow at a CAGR of 3.12% from 2024 to 2029[2].

Which region is expected to witness the highest CAGR in the sulfonylureas market?

The Middle East and Africa region is expected to witness the highest CAGR over the forecast period[2].

What are the key drivers of the glimepiride dispersible tablet market?

The primary drivers include the increasing global prevalence of type 2 diabetes, aging populations, rising obesity rates, and the advantages of dispersible tablets for ease of administration[5].

Sources

1. Wikipedia: Glimepiride.
2. Mordor Intelligence: Sulfonylureas Market - Share, Size & Growth.
3. Business Wire: Research and Markets: Amaryl (Type 2 Diabetes) - Analysis and Forecasts to 2020.
4. Diabetes Care: Efficacy and Safety of Glimepiride With or Without Linagliptin.
5. Data Horizzon Research: Glimepiride Dispersible Tablet Market Size, Growth and Analysis.