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Last Updated: July 14, 2025

CLINICAL TRIALS PROFILE FOR MICRONASE


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Micronase

Condition Name

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

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

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

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

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

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