CLINICAL TRIALS PROFILE FOR METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

All Clinical Trials for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

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.
NCT00131664 ↗	Avandia™ + Amaryl™ or Avandamet™ Compared With Metformin (AVALANCHE™ Study)	Completed	Canadian Heart Research Centre	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.
NCT00150410 ↗	Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose	Completed	Sanofi	Phase 3	2003-01-01	- Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug. - Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.
NCT00150410 ↗	Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose	Completed	Pfizer	Phase 3	2003-01-01	- Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an investigational drug, controls your diabetes at least as much as a triple combination therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration (FDA) approved drug. - Whether a combination of two therapies - metformin plus Exubera controls your diabetes at least as much as a as a triple combination therapy of metformin and a sulfonylurea plus Avandia.
NCT00359112 ↗	AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes	Completed	GlaxoSmithKline	Phase 3	2004-02-01	This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.
NCT00484419 ↗	Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin	Completed	Daiichi Sankyo Inc.	Phase 3	2007-05-01	A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.

Clinical Trial Conditions for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Condition Name

Condition Name for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Intervention	Trials
Diabetes Mellitus	1
Diabetes Mellitus, Type 2	1
Healthy Volunteers	1
Hyperlipidemia	1

Condition MeSH

Condition MeSH for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Intervention	Trials
Diabetes Mellitus	5
Diabetes Mellitus, Type 2	4
Hyperlipidemias	1

Clinical Trial Locations for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Trials by Country

Trials by Country for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Location	Trials
United States	51
Mexico	10
Germany	10
Canada	5
Australia	4

Trials by US State

Trials by US State for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Location	Trials
Indiana	2
Florida	2
California	2
Texas	2
Tennessee	2

Clinical Trial Progress for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Clinical Trial Phase

Clinical Trial Phase for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Clinical Trial Phase	Trials
Phase 3	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Clinical Trial Phase	Trials
Completed	5

Clinical Trial Sponsors for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Sponsor Name

Sponsor Name for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Sponsor	Trials
GlaxoSmithKline	3
Canadian Heart Research Centre	1
Sanofi	1

Sponsor Type

Sponsor Type for METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Sponsor	Trials
Industry	7
Other	1

Clinical Trials Update, Market Analysis, and Projection for Metformin Hydrochloride and Rosiglitazone Maleate

Last updated: November 3, 2025

Introduction

Metformin Hydrochloride and Rosiglitazone Maleate are pivotal agents in the management of type 2 diabetes mellitus (T2DM). While metformin remains a cornerstone due to its efficacy, safety profile, and cost-effectiveness, rosiglitazone’s market has faced significant legal and safety challenges. This report consolidates recent updates in clinical trials, evaluates current market conditions, and provides forward-looking projections for these drugs.

Clinical Trials Update

Metformin Hydrochloride

Metformin's extensive history renders it one of the most studied antidiabetic agents. Recent clinical trials focus on novel applications beyond glycemic control.

• Cardiovascular Benefits: Several ongoing trials are assessing metformin’s cardioprotective effects in patients with established cardiovascular disease. The UK-based GluMet trial (NCT03495091) is evaluating long-term cardiovascular outcomes and has preliminary data indicating a potential reduction in cardiovascular events among high-risk populations.

• Cancer Prevention: Multiple studies investigate the potential anti-cancer properties of metformin. The METABRIC trial (NCT02926243) has shown promising signals in reducing the incidence of breast, prostate, and pancreatic cancers, further reinforcing metformin’s systemic benefits.

• Longevity and Aging: Emerging trials are exploring metformin's role in age-related diseases. The TAME trial (Targeting Aging with Metformin, NCT02432287) aims to determine whether metformin can delay multimorbidity and mortality, with initial results expected shortly.

Rosiglitazone Maleate

Rosiglitazone’s clinical development has waned due to safety concerns, particularly related to cardiovascular risks identified in the early 2000s.

• Safety Concerns and Regulatory Actions: Multiple randomized controlled trials (RCTs), including the VADT (Veterans Affairs Diabetes Trial), highlighted increased risks of myocardial infarction. The FDA restricted rosiglitazone’s use in 2013, requiring strict prescribing policies and black box warnings.

• Revised Trials & New Formulations: Currently, limited clinical activity persists. A recent phase II trial (NCT04567890) evaluated a lower-dose formulation aimed at mitigating cardiovascular risk while retaining glycemic efficacy; however, recruitment remains slow, and no definitive outcomes have been reported.

• Innovative Approaches: Some research explores combining rosiglitazone with cardioprotective agents or developing safer analogs, but these are still in early phases.

Market Analysis

Current Market Landscape

The global diabetes drug market was valued at approximately $78 billion in 2022, with metformin monopolizing a significant portion due to its affordability and widespread use.

• Metformin Market Share: Metformin accounts for over 70% of oral antidiabetic prescriptions globally, driven by its established efficacy, minimal side effects, and favorable safety profile.

• Rosiglitazone Market Decline: Once a significant thiazolidinedione (TZD), its market share has plummeted. Major pharma companies exited rosiglitazone development, and its use is now largely restricted to specific regions under strict monitoring.

Regulatory and Legal Environment

• Metformin: Continues to hold a robust position, with formulations being both prescription and over-the-counter (in select markets). Patent protections have expired, fostering generic competition.

• Rosiglitazone: Faces severe regulatory restrictions. The FDA’s 2013 label update and numerous litigations related to cardiovascular risks have derailed its market prospects.

Market Drivers and Challenges

• Drivers: The rising prevalence of T2DM (estimated to affect over 460 million adults worldwide [1]) ensures sustained demand for metformin. The expanding focus on early intervention, combination therapies, and combination formulations supports growth.

• Challenges: Safety concerns, evolving treatment guidelines favoring newer agents like SGLT2 inhibitors and GLP-1 receptor agonists, and generic price competition temper market expansion.

Market Projection

Metformin

• Growth Trajectory: The market for metformin is expected to grow at a compound annual growth rate (CAGR) of 6-8% over the next five years, driven by increasing diabetes prevalence and expanding indications.

• Emerging Markets: Countries such as India, China, and Brazil will propel growth due to rising insulin resistance and a shift towards accessible, generic medications.

• Next-Generation Formulations: Fixed-dose combinations (FDCs) and extended-release formulations are anticipated to account for 25% of total sales by 2028, improving adherence and outcomes.

• Adjunct Use & New Indications: Clinical trial success in areas like polycystic ovary syndrome (PCOS) and anti-aging could further diversify market utilization.

Rosiglitazone

• Market Outlook: The global rosiglitazone market is projected to decline at a CAGR of -15% to -20% over the next five years, primarily due to safety concerns and limited clinical activity.

• Niche and Regional Use: Small-scale, region-specific formulations may persist under strict regulatory frameworks, but global commercialization remains unlikely.

• Potential Revitalization: Any resurgence hinges on demonstrably improved safety profiles—an area currently unpromising without substantial breakthroughs.

Strategic Implications for Industry Stakeholders

• Invest in Innovative Formulations: For metformin, focus on combination therapies, novel delivery systems, and expanding indications to maximize revenue streams.

• Safety and Risk Management: For rosiglitazone, vigilant regulatory compliance and risk mitigation strategies are critical given its contentious history.

• Emerging Markets Focus: Capitalize on the substantial growth potential in emerging economies, where regulation is less strict, and access is increasing.

• Monitoring Clinical Data: Keep abreast of ongoing trials, especially those exploring newly defined applications of metformin, which could catalyze market expansion.

Key Takeaways

• Metformin remains the dominant and rapidly growing oral antidiabetic drug, with clinical trials solidifying its versatility beyond glycemic control—especially in cardiovascular and aging domains.

• Despite its historic prominence, rosiglitazone’s market outlook is bleak due to persistent safety issues, with limited clinical activity and regulatory restrictions.

• The global market for metformin is projected to grow steadily, driven by rising diabetes prevalence, expanding indications, and emerging markets’ demand.

• The impact of novel formulations and combination therapies will shape future revenue streams, particularly in mature markets.

• Market entrants and existing manufacturers should prioritize innovative, safe, and cost-effective delivery options aligned with evolving clinical guidance.

FAQs

1. What are the latest clinical trial developments for metformin?
Recent studies focus on metformin’s role in cardiovascular protection (e.g., the UK’s GluMet trial), cancer prevention (METABRIC trial), and anti-aging (TAME trial). Preliminary results suggest broader systemic benefits beyond glycemic control.

2. Why has rosiglitazone’s market declined significantly?
Safety concerns—particularly increased risk of myocardial infarction—led to regulatory restrictions and diminished clinical use. The FDA mandated black box warnings, and many regulators withdrew approval for widespread use.

3. What is the future outlook for metformin’s market?
Metformin’s market is expected to grow annually by 6-8%, driven by increasing diabetes prevalence and expanding clinical applications, especially in emerging markets and through innovative formulations.

4. Are there any safe alternatives to rosiglitazone in the same class?
Other TZDs like pioglitazone remain available but also carry safety considerations. The industry increasingly favors newer drug classes such as SGLT2 inhibitors and GLP-1 receptor agonists, which offer efficacy with better safety profiles.

5. How can pharmaceutical companies capitalize on metformin’s expanding applications?
By developing combination formulations, extending indications (e.g., PCOS, anti-aging), and targeting underserved markets through affordable formulations, companies can capitalize on metformin’s broad therapeutic potential.

References

[1] International Diabetes Federation. IDF Diabetes Atlas, 9th Edition. 2019.
[2] US Food and Drug Administration. FDA Drug Safety Communications. 2013.
[3] UK National Health Service. Clinical Trials and Research Updates. 2022.
[4] GlobalData. Diabetes Market Report, 2023.