CLINICAL TRIALS PROFILE FOR GLIMEPIRIDE

505(b)(2) Clinical Trials for Glimepiride

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 Glimepiride

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.
NCT00095030 ↗	Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone	Completed	Merck Sharp & Dohme Corp.	Phase 3	2004-02-01	The purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. The safety of this treatment will also be studied.

Clinical Trial Conditions for Glimepiride

Condition Name

Condition Name for Glimepiride
Intervention	Trials
Diabetes Mellitus, Type 2	72
Type 2 Diabetes Mellitus	70
Type 2 Diabetes	26
Diabetes	18

Condition MeSH

Condition MeSH for Glimepiride
Intervention	Trials
Diabetes Mellitus, Type 2	186
Diabetes Mellitus	179
Hypoglycemia	4
Cardiovascular Diseases	3

Clinical Trial Locations for Glimepiride

Trials by Country

Trials by Country for Glimepiride
Location	Trials
United States	725
Germany	78
Canada	77
India	62
United Kingdom	61

Trials by US State

Trials by US State for Glimepiride
Location	Trials
Texas	38
California	33
Florida	32
Ohio	25
South Carolina	24

Clinical Trial Progress for Glimepiride

Clinical Trial Phase

Clinical Trial Phase for Glimepiride
Clinical Trial Phase	Trials
Phase 4	73
Phase 3	93
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Glimepiride
Clinical Trial Phase	Trials
Completed	176
Terminated	22
Unknown status	17

Clinical Trial Sponsors for Glimepiride

Sponsor Name

Sponsor Name for Glimepiride
Sponsor	Trials
Merck Sharp & Dohme Corp.	31
Sanofi	21
Novo Nordisk A/S	17

Sponsor Type

Sponsor Type for Glimepiride
Sponsor	Trials
Industry	222
Other	119
NIH	4

Glimepiride: Clinical Trials, Market Analysis, and Projections

Introduction to Glimepiride

Glimepiride is a third-generation sulfonylurea used to manage type 2 diabetes by stimulating the release of insulin from the pancreatic beta cells. It has been a cornerstone in diabetes treatment for decades, and its efficacy and safety have been extensively studied.

Clinical Trials Update

CAROLINA Trial

One of the most significant clinical trials involving glimepiride is the CAROLINA (Cardiovascular Outcome Study of Linagliptin vs Glimepiride in Type 2 Diabetes) trial. This randomized clinical trial compared the cardiovascular outcomes of patients with type 2 diabetes treated with either linagliptin or glimepiride. The trial found no significant difference in major adverse cardiovascular outcomes, all-cause death, or hospitalization for heart failure between the two groups. Both drugs demonstrated high adherence rates and effective glycemic control, with glimepiride showing a low risk of hospitalization due to hypoglycemia (0.9% over six years)[1].

Safety and Efficacy

A placebo-controlled, randomized study highlighted glimepiride's efficacy in lowering fasting plasma glucose (FPG) by 46 mg/dL, hemoglobin A1C (HbA1C) by 1.4%, and 2-hour postprandial glucose by 72 mg/dL compared to placebo. The study also showed that glimepiride improved postprandial insulin and C-peptide responses without significant increases in fasting insulin or C-peptide levels. The overall incidence of adverse events was similar to the placebo group, indicating the safety of glimepiride[4].

Market Analysis

Global Market Trends

The global glimepiride market is driven by several key factors:

• Growing Prevalence of Type 2 Diabetes: The increasing incidence of type 2 diabetes, largely due to rising obesity rates and sedentary lifestyles, is a primary driver. According to the International Diabetes Federation, the number of adults with diabetes is projected to reach 700 million by 2045[5].
• Demand for Effective Treatment Options: Patients are seeking more effective and convenient treatments, leading to a demand for drugs like glimepiride that offer good glycemic control[2][5].
• Focus on Patient Adherence: Drug companies are developing formulations that enhance patient adherence, such as extended-release tablets and dispersible tablets, which are particularly beneficial for patients with difficulty swallowing solid tablets[2][5].

Market Segments and Regions

• North America and Europe: These regions are expected to hold significant market shares due to the high prevalence of diabetes and well-established healthcare systems. North America is particularly dominant due to favorable reimbursement policies and the strong presence of innovative drug manufacturers[2][5].
• Asia-Pacific: This region is emerging as a key market due to the large patient populations in countries like China and India, along with increasing healthcare expenditure and improving access to medicines[2][5].
• Latin America and Middle East & Africa: These regions present significant growth opportunities due to rising healthcare infrastructure and improving healthcare access[2][5].

Competitive Landscape

The market includes a mix of global and regional pharmaceutical companies such as The Perrigo Company, Hoechst Marion Roussel, Elikem Pharmaceuticals Private Limited, Sanofi, and others. These companies are focusing on strategies like new product launches, geographical expansion, and collaborations to strengthen their market positions[2][5].

Market Projections

Growth Forecast

The global glimepiride tablet market is projected to reach a significant value by 2033, with a compound annual growth rate (CAGR) of several percent during the forecast period 2025-2033. The dispersible tablet market, in particular, is expected to reach over $1 billion by 2025, growing at a CAGR of around 5% during the forecast period[2][5].

Key Drivers

• Increasing Diabetes Prevalence: The rising global prevalence of type 2 diabetes is the primary driver of the market.
• Advantages of Dispersible Tablets: The ease of administration of dispersible tablets is a significant advantage, especially for the geriatric population.
• Technological Advancements: Development of new delivery systems, such as nanoparticles and dissolvable films, is expected to improve drug delivery and patient compliance[2][5].

Challenges and Opportunities

Challenges

• Side Effects and Competition: Sulfonylureas, including glimepiride, face challenges from side effects such as hypoglycemia and competition from alternative diabetes treatments like SGLT2 inhibitors and GLP-1 receptor agonists[3][5].
• Pricing Pressures: The increasing use of generic drugs and cost-containment measures by healthcare authorities pose pricing pressures on the market[5].

Opportunities

• Emerging Markets: Regions like Latin America, the Middle East, and Africa offer significant growth opportunities due to improving healthcare infrastructure and increasing awareness about diabetes management.
• Advanced Formulations: The development of advanced formulations and drug delivery systems can enhance efficacy and patient compliance, providing opportunities for market growth[2][5].

Key Takeaways

• Glimepiride has been proven safe and effective in clinical trials, particularly in the CAROLINA trial.
• The global glimepiride market is driven by the growing prevalence of type 2 diabetes and the demand for effective treatment options.
• North America and Europe are dominant markets, while Asia-Pacific is expected to be the fastest-growing region.
• The market faces challenges from side effects and competition but offers opportunities in emerging markets and advanced formulations.

FAQs

What is the primary use of glimepiride?

Glimepiride is used to manage type 2 diabetes by stimulating the release of insulin from the pancreatic beta cells.

What were the key findings of the CAROLINA trial?

The CAROLINA trial found no significant difference in major adverse cardiovascular outcomes between glimepiride and linagliptin, with both drugs showing high adherence rates and effective glycemic control.

Which regions are expected to dominate the glimepiride market?

North America and Europe are expected to hold significant market shares, while Asia-Pacific is emerging as a key market due to large patient populations and improving healthcare access.

What are the main drivers of the glimepiride market?

The main drivers include the growing prevalence of type 2 diabetes, demand for effective treatment options, and the advantages of dispersible tablets.

What challenges does the glimepiride market face?

The market faces challenges from side effects such as hypoglycemia and competition from alternative diabetes treatments, as well as pricing pressures from the increasing use of generic drugs.

Sources

1. A Verdict for Glimepiride: Effective and Not Guilty of Cardiovascular ... - Diabetes Care, 2019.
2. Glimepiride Tablet Competitive Strategies: Trends and Forecasts ... - Data Insights Market.
3. Trends in Antidiabetic Drug Discovery: FDA Approved Drugs, New ... - Frontiers in Pharmacology.
4. A placebo-controlled, randomized study of glimepiride in patients ... - PubMed.
5. Glimepiride Dispersible Tablet Market Size, Growth and Analysis ... - Data Horizon Research.

Last updated: 2025-01-01