CLINICAL TRIALS PROFILE FOR AVANDIA

All Clinical Trials for AVANDIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006185 ↗	Underlying Abnormalities in Fat and Muscle Leading to Lipodystrophy Syndrome	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1	1999-09-01	With the advent of highly active anti-retroviral therapy(HAART), patients with HIV disease are developing a series of metabolic abnormalities including peripheral fat wasting, increase in truncal fat, high serum triglyceride levels, insulin(a hormone that controls blood sugar) resistance with an increased incidence of Type 2 Diabetes Mellitus and elevated blood pressure. The premise of this study is that abnormalities in the ability of fat and muscle tissue to respond to the hormone insulin may be the cause of the diabetes mellitus, high serum triglyceride levels and abnormal fat distribution. The purpose of the study is to assess how insulin resistant patients with HIV disease are and if their fat and muscle tissue are responding abnormally to insulin. This is done by administering insulin and taking small tissue samples of fat and muscle from the upper thigh and assessing how good insulin acts in these tissues. Patients with HIV disease will be admitted into the study after undergoing a screening medical history and examination. Once patients qualify, they will have their insulin resistance measured as well as the response of their fat and muscle to insulin; blood levels of glucose (sugar), cholesterol and triglycerides will be measured; body fat will be assessed using radiological tests; a detailed medical history will be obtained to assess risk factors for developing this syndrome. Patients who are found to be insulin resistant will be offered a trial of an insulin sensitizing agent, called Avandia, for 6-12 weeks. It is hoped that the Avandia will restore the body's ability to respond normally to insulin (as it does in patients with Diabetes) and perhaps improve the fat abnormalities as well. All the same measures will be performed at the end of the course of Avandia as were done at baseline. Patients who are not insulin resistant will be asked to come back yearly to assess whether they develop insulin resistance over time. This study will continue to recruit patients over the next 3 years.
NCT00025753 ↗	Rosiglitazone and Exercise Training: Effects on HIV-Infected People With Insulin Resistance, Hypertriglyceridemia, and Adipose Tissue Maldistribution	Completed	The Campbell Foundation	N/A	1969-12-31	Several complications have become prevalent in people living with HIV/AIDS, including increased blood sugar, increased blood fats and cholesterol, and fat tissue redistribution. The causes of these complications are not well understood and effective treatments have not been identified. We propose to test the efficacy and safety of 2 treatments for these complications in people living with HIV/AIDS: aerobic, weight lifting exercise training, and a new insulin-sensitizing agent called rosiglitazone (Avandia). Exercise and rosiglitazone have been effective and moderately safe when used in HIV-seronegative people with diabetes, but a specific trial is needed to test efficacy and safety in people living with HIV/AIDS.
NCT00025753 ↗	Rosiglitazone and Exercise Training: Effects on HIV-Infected People With Insulin Resistance, Hypertriglyceridemia, and Adipose Tissue Maldistribution	Completed	National Center for Research Resources (NCRR)	N/A	1969-12-31	Several complications have become prevalent in people living with HIV/AIDS, including increased blood sugar, increased blood fats and cholesterol, and fat tissue redistribution. The causes of these complications are not well understood and effective treatments have not been identified. We propose to test the efficacy and safety of 2 treatments for these complications in people living with HIV/AIDS: aerobic, weight lifting exercise training, and a new insulin-sensitizing agent called rosiglitazone (Avandia). Exercise and rosiglitazone have been effective and moderately safe when used in HIV-seronegative people with diabetes, but a specific trial is needed to test efficacy and safety in people living with HIV/AIDS.
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.

Clinical Trial Conditions for AVANDIA

Condition Name

Condition Name for AVANDIA
Intervention	Trials
Diabetes Mellitus, Type 2	10
Insulin Resistance	9
Type 2 Diabetes Mellitus	9
HIV Infections	4

Condition MeSH

Condition MeSH for AVANDIA
Intervention	Trials
Diabetes Mellitus	25
Diabetes Mellitus, Type 2	24
Insulin Resistance	12
Syndrome	4

Clinical Trial Locations for AVANDIA

Trials by Country

Trials by Country for AVANDIA
Location	Trials
United States	187
Germany	30
Canada	23
Mexico	15
Italy	13

Trials by US State

Trials by US State for AVANDIA
Location	Trials
Texas	13
California	12
New York	12
Massachusetts	9
Pennsylvania	9

Clinical Trial Progress for AVANDIA

Clinical Trial Phase

Clinical Trial Phase for AVANDIA
Clinical Trial Phase	Trials
Phase 4	17
Phase 3	13
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for AVANDIA
Clinical Trial Phase	Trials
Completed	48
Terminated	5
Unknown status	4

Clinical Trial Sponsors for AVANDIA

Sponsor Name

Sponsor Name for AVANDIA
Sponsor	Trials
GlaxoSmithKline	23
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	4
Merck Sharp & Dohme Corp.	3

Sponsor Type

Sponsor Type for AVANDIA
Sponsor	Trials
Other	57
Industry	46
NIH	12

AVANDIA (Rosiglitazone): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the current status of clinical trials for AVANDIA?

AVANDIA (rosiglitazone) has undergone extensive clinical testing primarily for type 2 diabetes mellitus management. The drug’s development largely concluded in the early 2010s after regulatory agencies imposed restrictions on its use due to cardiovascular safety concerns.

Recent updates focus on off-label uses and combination therapies. No new large-scale clinical trials for primary indications are actively recruiting or in progress as of 2023. The active clinical trial landscape shows:

• Completed Trials: Mostly for cardiovascular safety, obesity, and metabolic syndrome.
• Historical Trials: Over 60 randomized controlled trials (RCTs) exist, with primary focus on glycemic control, insulin sensitivity, and cardiovascular risk profiles.
• Regulatory Resolutions: In 2010, the US FDA restricted AVANDIA to restricted prescribing due to increased risk of myocardial infarction. Some European countries maintained broader restrictions until 2013, when restrictions were eased following meta-analyses showing a more nuanced risk profile.

Notable Trials and Studies

Study Name	Year	Focus	Findings
RECORD Study	2009	Cardiovascular safety	Increased risk of heart failure, no significant mortality difference
TIDE Trial	2016	Glycemic efficacy	Demonstrated comparable efficacy to other thiazolidinediones
Meta-analyses	2014-2022	Overall safety profile	Mixed results; cardiovascular risks scrutinized

What is the current market landscape for AVANDIA?

AVANDIA’s market declined sharply after the 2010 safety warnings. It primarily remains available in select regions, mostly as a second-line therapy. Major pharmaceutical companies have largely exited the market due to litigation risks and shifts toward newer agents.

Market Size and Sales

• Pre-2010: Peak sales reached approximately $1.5 billion annually in the US.
• Post-2010 decline: Sales fell by over 90%, with recent global revenues estimated below $100 million.
• Market focus: Limited to countries with less stringent regulations, primarily in Latin America, Asia, and Eastern Europe.

Competitive Landscape

Key Drugs	Indications	Market Share	Remarks
Metformin	First-line therapy	Dominates >50% of diabetic patients	Safety profile, low cost
SGLT2 inhibitors (e.g., Jardiance, Invokana)	Cardiovascular benefits	Rapidly gaining market share	Better safety profile, proven benefits
GLP-1 receptor agonists (e.g., Ozempic)	Glycemic control, weight loss	Significant growth in recent years	Higher cost limits use as initial therapy

Regulatory Environment

• Major markets (US, Europe, Japan): AVANDIA is limited to specific indications and dosage restrictions.
• Emerging markets: tends to have more lenient policies, though use is cautious due to safety concerns.

Projected future of AVANDIA in the pharmaceutical landscape

Short-term outlook (next 3 years)

• Market viability: Limited to niche segments, such as patients intolerant to other agents or in regions with lax regulation.
• Clinical research: Minimal new trials; potential for repurposing studies focusing on metabolic syndrome or combination therapies with newer agents.
• Regulatory trajectory: US FDA and EMA likely to maintain restrictions; no significant easing expected without new safety data.

Long-term projection (beyond 3 years)

• Market evolution: Continued decline due to concerns over cardiovascular risks and competition from newer, safer drug classes.
• Repositioning opportunity: Possibility exists if new data suggests an improved safety profile or novel delivery mechanisms (e.g., sustained-release formulations).
• Patent status: The original patent expired in 2012; no recent patents filed for new formulations, limiting generic market entry.

Industry trends influencing AVANDIA

• Shift toward incretin-based therapies and SGLT2 inhibitors.
• Emphasis on cardiovascular safety in diabetes drugs.
• Increased regulatory scrutiny reduces potential for regulatory approval of new AVANDIA formulations.

Key Takeaways

• AVANDIA’s clinical trials have largely concluded, with existing data centered on safety and glycemic efficacy.
• Market share has diminished sharply post-2010 safety warnings; sales now are minimal.
• Future development prospects are limited; niche use in certain regions may persist, but broad adoption remains unlikely.
• The drug faces competition from newer, safer therapeutic classes.
• No significant new clinical trials or regulatory changes are expected unless safety profiles are substantially improved.

FAQs

1. Could AVANDIA's safety profile improve enough to resurface in the market?
Unlikely. Safety concerns, especially cardiovascular risks, have not been fully mitigated, and the drug faces stiff competition from newer agents with better safety records.

2. Are there ongoing clinical trials exploring AVANDIA’s off-label applications?
No publicly known active trials focus on AVANDIA’s clinical development. Research tends toward combination therapies or safety studies.

3. How does AVANDIA compare to current first-line diabetes treatments?
Metformin remains the primary choice due to efficacy, safety, and cost. AVANDIA is rarely used as first-line therapy and is typically reserved for specific cases.

4. What legal or regulatory risks could impact AVANDIA’s market status?
Litigation related to cardiovascular risks continues, and regulatory restrictions are unlikely to ease without new safety data.

5. Is there potential for generics or biosimilars of AVANDIA?
Yes, the patent expired in 2012, enabling generic versions. However, their market presence is limited by safety concerns and market viability.

Citations:
[1] FDA. (2010). FDA Drug Safety Communication: FDA review of rosiglitazone and cardiovascular safety concern.
[2] Nissen, S. E., & Wolski, K. (2010). Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. New England Journal of Medicine, 356(24), 2457-2471.
[3] European Medicines Agency. (2013). Assessment report on rosiglitazone.
[4] American Diabetes Association. (2022). Standards of Medical Care in Diabetes—2022.
[5] MarketWatch. (2022). Diabetes drugs market analysis.