CLINICAL TRIALS PROFILE FOR ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

All Clinical Trials for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

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.

Clinical Trial Conditions for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Condition Name

Condition Name for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Intervention	Trials
Diabetes Mellitus, Type 2	1
Healthy Volunteers	1
Hyperlipidemia	1
Non-Insulin-Dependent Diabetes Mellitus	1

Condition MeSH

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

Clinical Trial Locations for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Trials by Country

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

Trials by US State

Trials by US State for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
Location	Trials
North Carolina	2
New York	2
Maryland	2
Indiana	2
Florida	2

Clinical Trial Progress for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE

Sponsor Name

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

Sponsor Type

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

ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE Market Analysis and Financial Projection

Rosiglitazone Maleate and Metformin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

The combination of rosiglitazone maleate and metformin hydrochloride has been a significant focus in the management of type 2 diabetes due to its synergistic effects on glycemic control and insulin sensitivity. Here, we will delve into the clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials and Efficacy

Mechanism of Action

Rosiglitazone maleate, a thiazolidinedione, targets insulin resistance by binding to the peroxisome proliferator-activated receptor-γ (PPAR-γ), promoting glucose uptake and adipocyte differentiation. Metformin hydrochloride, on the other hand, reduces hepatic glucose production and enhances peripheral glucose uptake[1][2][4].

Key Clinical Trials

A randomized, double-blind, placebo-controlled trial evaluated the efficacy of adding rosiglitazone to maximal doses of metformin in patients with poorly controlled type 2 diabetes. The study found that the combination significantly improved glycemic control, insulin sensitivity, and β-cell function compared to metformin alone. Patients receiving 4 mg/day and 8 mg/day of rosiglitazone showed significant reductions in HbA1c levels and fasting plasma glucose concentrations[1].

Another meta-analysis confirmed that the combination of rosiglitazone with metformin resulted in greater reductions in HbA1c levels compared to monotherapy or placebo, with dose-dependent improvements in insulin sensitivity and β-cell function[2].

Long-Term Safety and Efficacy

Long-term studies, including open-label extension trials, have assessed the safety, tolerability, and efficacy of rosiglitazone when administered with metformin. These studies indicate that the combination is well-tolerated and maintains its efficacy over extended periods, with benefits in preserving pancreatic β-cell function and improving endothelial function[3].

Market Analysis

Current Market Size and Growth

The global market for metformin hydrochloride, a key component of this combination, was valued at approximately USD 268.95 million in 2022. It is projected to grow to USD 386.91 million by 2030, with a compound annual growth rate (CAGR) of 4.7% during the forecast period. The Asia-Pacific region is expected to lead this growth due to the high prevalence of type 2 diabetes in countries like China and India[5].

Market Segmentation

The metformin hydrochloride market is segmented based on application, distribution channel, and region. The immediate release segment has shown the highest growth due to its convenience and effectiveness. However, combination medicines, including those with rosiglitazone, are also significant segments, driven by their clinical benefits and patient adherence[5].

Projections and Future Outlook

Increasing Demand

The growing number of people living with type 2 diabetes, particularly in the Asia-Pacific region, is expected to drive the demand for effective antidiabetic medications like the rosiglitazone-metformin combination. Factors such as population growth, aging, and lifestyle changes are contributing to this trend[5].

Once-Daily Formulations

The development of once-daily, single-pill formulations of rosiglitazone and metformin is expected to enhance patient adherence and improve clinical outcomes. These formulations leverage the existing clinical experience and knowledge about the combination, offering the added benefit of simplified dosing regimens[4].

Clinical Practice Guidelines

Clinical practice guidelines continue to emphasize the importance of glycemic control in preventing diabetes complications. The combination of rosiglitazone and metformin is likely to remain a recommended treatment option due to its proven efficacy in lowering HbA1c levels, improving insulin sensitivity, and minimizing weight gain[4].

Key Takeaways

• Clinical Efficacy: The combination of rosiglitazone maleate and metformin hydrochloride has been shown to significantly improve glycemic control, insulin sensitivity, and β-cell function in patients with type 2 diabetes.
• Market Growth: The global metformin hydrochloride market is projected to grow at a CAGR of 4.7% from 2023 to 2030, driven by increasing demand in the Asia-Pacific region.
• Once-Daily Formulations: New once-daily formulations are expected to enhance patient adherence and improve clinical outcomes.
• Long-Term Safety: Long-term studies indicate that the combination is well-tolerated and maintains its efficacy over extended periods.

FAQs

Q: What is the mechanism of action of rosiglitazone maleate and metformin hydrochloride?

A: Rosiglitazone targets insulin resistance by binding to PPAR-γ, while metformin reduces hepatic glucose production and enhances peripheral glucose uptake.

Q: What were the key findings of the clinical trials on the combination of rosiglitazone and metformin?

A: Clinical trials showed significant improvements in glycemic control, insulin sensitivity, and β-cell function compared to metformin alone.

Q: What is the projected growth of the metformin hydrochloride market?

A: The global metformin hydrochloride market is expected to grow from USD 268.95 million in 2022 to USD 386.91 million by 2030, with a CAGR of 4.7%.

Q: Which region is expected to lead the growth in the metformin hydrochloride market?

A: The Asia-Pacific region is expected to lead the growth due to the high prevalence of type 2 diabetes in countries like China and India.

Q: What are the benefits of once-daily formulations of rosiglitazone and metformin?

A: Once-daily formulations are expected to enhance patient adherence and improve clinical outcomes by simplifying dosing regimens.

Sources

1. Effect of Metformin and Rosiglitazone Combination Therapy in Patients With Type 2 Diabetes Poorly Controlled With Metformin Alone. JAMA Network.
2. A Meta-analysis Comparing the Effect of Thiazolidinediones on Glycemic Control. JAMA Internal Medicine.
3. Heterogenous Effects in Diabetes Mellitus Clinical Trials and Implications for Physician Prescriptions. Vivli.
4. Rosiglitazone maleate + metformin hydrochloride extend. PubMed.
5. Metformin Hydrochloride Market Size, Share and Forecast 2030. Zion Market Research.