CLINICAL TRIALS PROFILE FOR MICRONASE

All Clinical Trials for Micronase

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00759720 ↗	Efficacy and Safety of TAK-559 Combined With Glyburide in Treating Subjects With Type 2 Diabetes Mellitus.	Terminated	Takeda	Phase 3	2003-11-01	The purpose of this study is to determine the safety and efficacy of TAK-559, once daily (QD), combined with glyburide in treating Type 2 Diabetes.
NCT00770835 ↗	Efficacy and Safety of Pioglitazone in Treating Subjects With Vascular Complications Associated With Type 2 Diabetes Mellitus.	Completed	Takeda	Phase 4	2009-03-01	The purpose of this study is to determine the efficacy of pioglitazone compared to glibenclamide, once daily (QD), taken together with metformin and lifestyle modification in type 2 diabetic subjects with cardiovascular disease.
NCT01068860 ↗	To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies	Completed	Novartis	Phase 2	2010-02-01	This was a 10-week, placebo-controlled, randomized study to investigate the effect of injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.
NCT01716338 ↗	Glyburide Healthy Volunteer Study	Completed	United States Department of Defense	Phase 1	2013-01-01	Glyburide is a medication that has been safely used for several decades to treat non-insulin dependent diabetes. This pilot study seeks to evaluate whether glyburide, administered at the lowest dose (1.5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and cognitively. The investigators are hopeful that the results of this study will provide the necessary foundation to evaluate this medication's use on a larger scale to determine the feasibility of using glyburide in soldiers either prophylactically or for the treatment of brain injury.
NCT01716338 ↗	Glyburide Healthy Volunteer Study	Completed	University of Maryland	Phase 1	2013-01-01	Glyburide is a medication that has been safely used for several decades to treat non-insulin dependent diabetes. This pilot study seeks to evaluate whether glyburide, administered at the lowest dose (1.5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and cognitively. The investigators are hopeful that the results of this study will provide the necessary foundation to evaluate this medication's use on a larger scale to determine the feasibility of using glyburide in soldiers either prophylactically or for the treatment of brain injury.
NCT01716338 ↗	Glyburide Healthy Volunteer Study	Completed	University of Maryland, College Park	Phase 1	2013-01-01	Glyburide is a medication that has been safely used for several decades to treat non-insulin dependent diabetes. This pilot study seeks to evaluate whether glyburide, administered at the lowest dose (1.5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and cognitively. The investigators are hopeful that the results of this study will provide the necessary foundation to evaluate this medication's use on a larger scale to determine the feasibility of using glyburide in soldiers either prophylactically or for the treatment of brain injury.
NCT01716338 ↗	Glyburide Healthy Volunteer Study	Completed	Washington University School of Medicine	Phase 1	2013-01-01	Glyburide is a medication that has been safely used for several decades to treat non-insulin dependent diabetes. This pilot study seeks to evaluate whether glyburide, administered at the lowest dose (1.5 mg/dL daily) to healthy (non-diabetic) subjects is safe both physically and cognitively. The investigators are hopeful that the results of this study will provide the necessary foundation to evaluate this medication's use on a larger scale to determine the feasibility of using glyburide in soldiers either prophylactically or for the treatment of brain injury.

Clinical Trial Conditions for Micronase

Condition Name

Condition Name for Micronase
Intervention	Trials
Diabetes Mellitus	2
Gestational Diabetes	1
Healthy	1
Healthy Volunteers	1

Condition MeSH

Condition MeSH for Micronase
Intervention	Trials
Diabetes Mellitus	3
Diabetes Mellitus, Type 2	2
Glucose Intolerance	1
Diabetes, Gestational	1

Clinical Trial Locations for Micronase

Trials by Country

Trials by Country for Micronase
Location	Trials
United States	9
Italy	8
India	7
Canada	2
Finland	1

Trials by US State

Trials by US State for Micronase
Location	Trials
Texas	2
Missouri	1
Utah	1
Pennsylvania	1
North Dakota	1

Clinical Trial Progress for Micronase

Clinical Trial Phase

Clinical Trial Phase for Micronase
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Micronase
Clinical Trial Phase	Trials
Completed	4
Terminated	2

Clinical Trial Sponsors for Micronase

Sponsor Name

Sponsor Name for Micronase
Sponsor	Trials
Takeda	2
Texas Tech University Health Sciences Center, El Paso	1
Novartis	1

Sponsor Type

Sponsor Type for Micronase
Sponsor	Trials
Industry	4
Other	4
U.S. Fed	1

Micronase: Clinical Trials, Market Analysis, and Projections

Last updated: January 2, 2025

Introduction to Micronase

Micronase, also known as glyburide, is a sulfonylurea used in the management of type 2 diabetes. However, the focus here will be on a related class of drugs, the Glucagon-like Peptide-1 (GLP-1) receptor agonists, as they are more relevant to current clinical trials and market trends. This article will delve into the clinical trials, market analysis, and projections for GLP-1 agonists, which are closely related to the broader context of diabetes management.

Clinical Trials Update on GLP-1 Agonists

Danuglipron Clinical Trials

One of the notable clinical trials in the GLP-1 agonist space is the Phase 2b trial of danuglipron, an oral GLP-1 receptor agonist developed by Pfizer. This trial was conducted from July 7, 2020, to July 7, 2021, across 97 clinical research sites in 8 countries, including the US, Canada, and several European and Asian countries[1].

• Design and Participants: The trial was a double-blind, placebo-controlled, parallel-group study involving adults with type 2 diabetes inadequately controlled by diet and exercise, with or without metformin treatment.
• Dosing and Follow-Up: Participants were randomized to receive either a placebo or danuglipron at various doses (2.5, 10, 40, 80, or 120 mg twice daily). The trial included a dose escalation period for higher doses and a 4-week follow-up period after the 16-week treatment phase[1].
• Outcomes: The study met its primary endpoint, demonstrating a statistically significant change in body weight from baseline in adults with obesity and without type 2 diabetes. However, Pfizer has decided not to advance the twice-daily formulation into Phase 3 studies and is instead focusing on a once-daily formulation to improve tolerability[4].

Safety and Tolerability

The trial also evaluated the safety and tolerability of danuglipron. Despite some participants discontinuing due to COVID-19-related reasons, the overall safety profile was acceptable, although dose escalation was necessary to manage side effects for higher doses[1].

Market Analysis of GLP-1 Agonists

Global Market Size and Growth

The GLP-1 agonists market is projected to reach USD 12.12 billion by 2025 and grow at a CAGR of 1.12% to reach USD 12.82 billion by 2030. This growth is driven by the increasing prevalence of diabetes and obesity, as well as the favorable safety profile of GLP-1 agonists compared to other diabetes medications[2].

Regional Market Dynamics

• North America: The North America GLP-1 agonists market is estimated at USD 6.89 billion in 2025 but is expected to decline slightly to USD 6.63 billion by 2030, reflecting a CAGR of -0.76% during this period. This decline is attributed to market saturation and potential competition from newer therapies[5].
• Middle East and Africa: This region is expected to be the fastest-growing market for GLP-1 agonists, driven by increasing healthcare spending and a growing awareness of diabetes management[2].

Key Players

Major players in the GLP-1 agonists market include AstraZeneca, Eli Lilly and Company, Sanofi, Novo Nordisk A/S, and Pfizer Inc. These companies are continuously innovating and expanding their product portfolios to capture a larger share of the market[2].

Benefits and Advantages of GLP-1 Agonists

Anti-Inflammatory and Pulmonary Protective Effects

GLP-1 agonists have been shown to have significant anti-inflammatory and pulmonary protective effects, in addition to their glucose-lowering properties. This makes them a valuable option for patients with type 2 diabetes and other metabolic disorders[5].

Impact on Gut Microbes

These medications also have a beneficial impact on the composition of gut microbes, which is crucial for overall metabolic health and immune function[5].

Market Projections and Future Outlook

Growth Drivers

The market for GLP-1 agonists is expected to grow due to several factors:

• Increasing Prevalence of Diabetes and Obesity: The rising global incidence of diabetes and obesity is driving the demand for effective and safe treatments.
• Favorable Safety Profile: GLP-1 agonists have a lower risk of causing hypoglycemia compared to other diabetes medications, making them a preferred choice for many patients[2].

Challenges and Risks

Despite the positive outlook, there are challenges and risks associated with the development and market penetration of GLP-1 agonists:

• Regulatory Uncertainties: The approval process for new formulations, such as the once-daily danuglipron, is subject to regulatory uncertainties and the interpretation of clinical data by regulatory authorities[4].
• Competition: The market is highly competitive, with multiple players and ongoing innovation, which can impact market share and growth[2].

Key Takeaways

• Clinical Trials: Danuglipron, an oral GLP-1 agonist, has shown promising results in Phase 2b trials but will be further developed in a once-daily formulation.
• Market Size: The global GLP-1 agonists market is expected to reach USD 12.12 billion by 2025 and grow to USD 12.82 billion by 2030.
• Regional Dynamics: North America is the largest market, but the Middle East and Africa are expected to be the fastest-growing regions.
• Benefits: GLP-1 agonists offer a favorable safety profile, anti-inflammatory effects, and a positive impact on gut microbes.

FAQs

What is the current market size of the GLP-1 agonists market?

The GLP-1 agonists market size is expected to reach USD 12.12 billion in 2025[2].

Which region is the fastest-growing market for GLP-1 agonists?

The Middle East and Africa region is estimated to grow at the highest CAGR over the forecast period (2025-2030)[2].

What are the key benefits of GLP-1 agonists?

GLP-1 agonists have a lower risk of causing hypoglycemia, significant anti-inflammatory and pulmonary protective effects, and a beneficial impact on gut microbes[5].

Who are the major players in the GLP-1 agonists market?

Major players include AstraZeneca, Eli Lilly and Company, Sanofi, Novo Nordisk A/S, and Pfizer Inc.[2].

What is the future development focus for danuglipron?

Future development of danuglipron will focus on a once-daily formulation to improve tolerability and optimize the study design and execution[4].

Sources

1. JAMA Network Open: "Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron in Adults With Type 2 Diabetes: A Randomized Clinical Trial"[1].
2. Mordor Intelligence: "Glucagon-like Peptide-1 (GLP-1) Agonists Market Size"[2].
3. Mordor Intelligence: "Microneedle Drug Delivery Systems Market Size & Share Analysis"[3].
4. Pfizer: "Pfizer Announces Topline Phase 2b Results of Oral GLP-1R Agonist Danuglipron in Adults with Obesity and Without Type 2 Diabetes"[4].
5. Mordor Intelligence: "North America Glucagon-like Peptide-1 Agonists Market Analysis"[5].