CLINICAL TRIALS PROFILE FOR AVANDAMET

All Clinical Trials for AVANDAMET

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00110851 ↗	Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)	Completed	Wellstat Therapeutics	Phase 2	2005-04-01	This study is designed to evaluate the safety and efficacy of PN2034 administered to type 2 diabetics on concomitant rosiglitazone and metformin (or Avandamet) therapy as measured by change in glycosylated hemoglobin (HbA1c) levels from baseline to Week 12. Also the study will evaluate the effect of PN2034 on glucose control as measured by fasting plasma glucose (FPG) and on fasting lipid levels: triglycerides, total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), and very low-density lipoproteins (VLDL).
NCT00116922 ↗	A Lifestyle and Combination Medication Therapy Diabetes Prevention Study	Completed	University of Western Ontario, Canada	Phase 3	2004-06-01	It is now well established that the 21st century will be characterized by a global epidemic of Type 2 diabetes. The principal aim of the CANOE study is to determine whether individuals with the pre-diabetes condition impaired glucose tolerance can be prevented from progressing to diabetes with a healthy living lifestyle intervention and an insulin sensitizing medication. Individuals who have impaired glucose tolerance (IGT) determined during an oral glucose tolerance test will be eligible to participate in this study. All participants will receive a lifestyle dietary and exercise intervention program. Half of the participants will be randomly assigned to an insulin sensitizing medication (rosiglitazone/metformin) which is commonly used to treat Type 2 diabetes. The primary outcome for this study is the development of diabetes. The study is expected to last a total of five years.
NCT00116922 ↗	A Lifestyle and Combination Medication Therapy Diabetes Prevention Study	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	Phase 3	2004-06-01	It is now well established that the 21st century will be characterized by a global epidemic of Type 2 diabetes. The principal aim of the CANOE study is to determine whether individuals with the pre-diabetes condition impaired glucose tolerance can be prevented from progressing to diabetes with a healthy living lifestyle intervention and an insulin sensitizing medication. Individuals who have impaired glucose tolerance (IGT) determined during an oral glucose tolerance test will be eligible to participate in this study. All participants will receive a lifestyle dietary and exercise intervention program. Half of the participants will be randomly assigned to an insulin sensitizing medication (rosiglitazone/metformin) which is commonly used to treat Type 2 diabetes. The primary outcome for this study is the development of diabetes. The study is expected to last a total of five years.
NCT00069836 ↗	Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.	Completed	GlaxoSmithKline	Phase 3	2003-10-01	This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in combination with insulin in improving the control of blood sugar when compared with taking insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both AVANDIA and metformin are medicines which are individually licensed for the treatment of type II diabetes mellitus. Because they act in different ways, it is thought that combining them may give an increased benefit of treating diabetes and reducing blood sugar.

Clinical Trial Conditions for AVANDAMET

Condition Name

Condition Name for AVANDAMET
Intervention	Trials
Diabetes Mellitus, Type 2	6
Type 2 Diabetes Mellitus	2
Diabetes	2
Healthy Volunteers	1

Condition MeSH

Condition MeSH for AVANDAMET
Intervention	Trials
Diabetes Mellitus, Type 2	9
Diabetes Mellitus	9
Liver Diseases	1
Glucose Intolerance	1

Clinical Trial Locations for AVANDAMET

Trials by Country

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Trials by Country for AVANDAMET
Location	Trials
United States	77
Germany	22
Canada	17
Italy	9
Mexico	8

Trials by US State

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Trials by US State for AVANDAMET
Location	Trials
Texas	5
South Carolina	3
Pennsylvania	3
Oregon	3
North Carolina	3

Clinical Trial Progress for AVANDAMET

Clinical Trial Phase

Clinical Trial Phase for AVANDAMET
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	5
Phase 2	3

Clinical Trial Status

Clinical Trial Status for AVANDAMET
Clinical Trial Phase	Trials
Completed	12
Terminated	1
Unknown status	1

Clinical Trial Sponsors for AVANDAMET

Sponsor Name

Sponsor Name for AVANDAMET
Sponsor	Trials
GlaxoSmithKline	8
Albert Einstein College of Medicine	1
Albert Einstein College of Medicine of Yeshiva University	1

Sponsor Type

Sponsor Type for AVANDAMET
Sponsor	Trials
Industry	10
Other	10
U.S. Fed	1

Clinical Trials, Market Analysis, and Projections for Avandamet

Introduction to Avandamet

Avandamet is a prescription medication that combines rosiglitazone and metformin, used to treat type 2 diabetes mellitus (T2DM). Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Purpose and Design

Clinical trials for Avandamet have been conducted to evaluate its efficacy and safety. One notable study was a phase IV, randomized, double-blind, multi-centre trial that compared Avandamet (rosiglitazone/metformin) with metformin monotherapy. The study aimed to determine if Avandamet could achieve superior glycaemic control and if these effects were durable over 18 months[4].

Key Findings

The trial involved 688 drug-naïve patients with T2DM, randomized in a 1:1 ratio to either Avandamet or metformin. The results showed that Avandamet achieved superior glycaemic control compared to metformin monotherapy, and these effects were sustained over the 18-month treatment period. However, Avandamet was associated with a significant reduction in bone mineral density (BMD) in the lumbar spine and total hip compared to metformin[4].

Regulatory Updates

EMA and FDA Decisions

Following reviews by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), significant regulatory actions were taken. In the European Union, the EMA suspended the marketing authorization for all rosiglitazone-containing medicines, including Avandamet, due to concerns over cardiovascular risks. Patients were advised to transition to alternative treatments unless convincing data showed benefits outweighing the risks[1].

In the US, the FDA allowed rosiglitazone-containing medicines, including Avandamet, to remain available but with additional safety labeling and restrictions. The FDA also required a Risk Evaluation and Mitigation Strategy (REMS) program and an independent re-adjudication of the endpoints reported in the RECORD study[1].

Market Analysis

Current Market Size and Growth

The endocrinology drugs market, which includes medications like Avandamet, has seen significant growth. In 2024, the global endocrinology drugs market was valued at $35.05 billion and is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.34%, reaching $53.85 billion by 2030[2].

Impact of Regulatory Decisions

The regulatory decisions by the EMA and FDA have significantly impacted the market for Avandamet. The suspension of marketing authorization in the EU has reduced the drug's availability and sales in that region. In the US, while the drug remains available, the additional safety measures and restrictions have likely affected its market share and growth potential.

Competitive Landscape

The diabetes treatment market is highly competitive, with various medications and treatment options available. Avandamet faces competition from other oral antidiabetic drugs, insulin therapies, and newer classes of medications such as SGLT2 inhibitors and GLP-1 receptor agonists. The market share of Avandamet has likely been affected by these competitors and the regulatory actions taken against it.

Future Projections

Market Trends and Opportunities

Despite the regulatory challenges, the demand for diabetes treatments continues to rise due to the increasing prevalence of type 2 diabetes globally. However, Avandamet's future growth is limited by the regulatory restrictions and the availability of alternative treatments.

Technological and Regulatory Factors

Advancements in diabetes treatment technologies, such as continuous glucose monitoring systems and innovative drug delivery methods, are shaping the market. Regulatory factors, including stricter safety requirements and the need for robust clinical evidence, will continue to influence the market for Avandamet and similar drugs.

Key Takeaways

• Clinical Efficacy: Avandamet has shown superior glycaemic control compared to metformin monotherapy, but with concerns over bone mineral density.
• Regulatory Status: The drug faces significant regulatory restrictions, particularly in the EU where its marketing authorization has been suspended.
• Market Growth: The endocrinology drugs market is growing, but Avandamet's share is likely impacted by regulatory decisions and competitive pressures.
• Future Outlook: The drug's future is constrained by regulatory actions and the availability of alternative treatments.

FAQs

What is Avandamet used for?

Avandamet is a prescription medication used to treat type 2 diabetes mellitus (T2DM) by combining rosiglitazone and metformin.

Why was Avandamet's marketing authorization suspended in the EU?

The European Medicines Agency (EMA) suspended the marketing authorization for Avandamet due to concerns over cardiovascular risks associated with rosiglitazone.

What are the key findings from clinical trials of Avandamet?

Clinical trials showed that Avandamet achieved superior glycaemic control compared to metformin monotherapy, but it was associated with a significant reduction in bone mineral density.

How has the FDA regulated Avandamet in the US?

The FDA has allowed Avandamet to remain available in the US but with additional safety labeling, restrictions, and a Risk Evaluation and Mitigation Strategy (REMS) program.

What is the projected growth of the endocrinology drugs market?

The global endocrinology drugs market is expected to grow at a CAGR of 7.34%, reaching $53.85 billion by 2030 from $35.05 billion in 2024.

Sources

1. GSK regulatory update on Avandia following EMA and FDA reviews. GlaxoSmithKline. Retrieved from https://www.gsk.com/en-gb/media/press-releases/gsk-regulatory-update-on-avandia-following-ema-and-fda-reviews/
2. Endocrinology Drugs Market Analysis by Therapy Area, Distribution Channel, and Region - A Forecasted $53.85 Billion Industry by 2030. GlobeNewswire. Retrieved from https://www.globenewswire.com/news-release/2024/11/20/2984633/28124/en/Endocrinology-Drugs-Market-Analysis-by-Therapy-Area-Distribution-Channel-and-Region-A-Forecasted-53-85-Billion-Industry-by-2030.html
3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033. BioSpace. Retrieved from https://www.biospace.com/u-s-clinical-trials-market-size-industry-analysis-report-2033
4. A randomized, parallel group, double-blind, multicentre study to evaluate the efficacy and safety of Avandamet (rosiglitazone/metformin) compared with metformin monotherapy in drug-naïve patients with type 2 diabetes mellitus. PubMed. Retrieved from https://pubmed.ncbi.nlm.nih.gov/21682834/