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.
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.
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.

Clinical Trial Conditions for metformin hydrochloride; rosiglitazone maleate

Condition Name

Condition Name for metformin hydrochloride; rosiglitazone maleate
Intervention	Trials
Healthy Volunteers	1
Hyperlipidemia	1
Non-Insulin-Dependent Diabetes Mellitus	1
Type 2 Diabetes	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

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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

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−

Trials by US State for metformin hydrochloride; rosiglitazone maleate
Location	Trials
Texas	2
Tennessee	2
South Carolina	2
Pennsylvania	2
Oregon	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

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

Introduction

Metformin hydrochloride and rosiglitazone maleate are two significant medications in the management of type 2 diabetes mellitus (T2DM). This article delves into the current clinical trials, market analysis, and future projections for these drugs, highlighting their efficacy, safety, and market dynamics.

Clinical Efficacy of Metformin Hydrochloride

Metformin Hydrochloride in T2DM Treatment

Metformin hydrochloride is a cornerstone in the treatment of T2DM, known for its ability to lower blood glucose levels by reducing hepatic glucose production and increasing insulin sensitivity. A recent clinical trial compared the efficacy and safety of metformin hydrochloride sustained-release (SR) tablets with the original metformin hydrochloride tablets. The study involved 886 patients with T2DM, randomly assigned to either the SR or the original formulation for 16 weeks. Both forms of metformin were found to be equally effective in reducing glycated hemoglobin (HbA1c) and fasting blood glucose (FBG) levels, as well as promoting weight loss[1].

Combination Therapies

Metformin is often used in combination with other antidiabetic agents to enhance glycemic control. For instance, combining metformin with rosiglitazone maleate has been shown to result in greater reductions in HbA1c levels compared to monotherapy. This combination also improves insulin sensitivity and minimizes weight gain[3].

Clinical Efficacy of Rosiglitazone Maleate

Rosiglitazone Maleate in T2DM Treatment

Rosiglitazone maleate, a thiazolidinedione, enhances insulin sensitivity and is used to improve glycemic control in T2DM patients. When combined with metformin, rosiglitazone has been shown to lower HbA1c levels significantly. A meta-analysis indicated that the combination of rosiglitazone with metformin, sulfonylureas, or insulin resulted in greater reductions in HbA1c levels compared to placebo[2].

Safety and Efficacy Profile

The combination of rosiglitazone and metformin has been evaluated for its safety and efficacy. While it is effective in lowering blood glucose levels and improving insulin sensitivity, it also comes with certain precautions, particularly regarding cardiovascular risks in the geriatric population. Clinical studies suggest that the use of rosiglitazone in elderly patients may be associated with differences in safety, including increased cardiovascular risks[5].

Market Analysis

Current Market Trends

The global market for antidiabetic drugs is growing rapidly, driven by the increasing prevalence of diabetes. Metformin hydrochloride and rosiglitazone maleate are key players in this market. Metformin, being a first-line treatment for T2DM, dominates the market due to its efficacy, safety profile, and cost-effectiveness.

Market Share and Competition

The market share of metformin hydrochloride is substantial due to its widespread use as a monotherapy and in combination with other antidiabetic agents. Rosiglitazone maleate, although effective, has faced challenges due to safety concerns, particularly regarding cardiovascular risks. This has led to a more cautious approach in its prescription and a lower market share compared to metformin.

Future Projections

Emerging Trends and Technologies

The antidiabetic drug market is expected to see significant growth with the emergence of new technologies and formulations. For instance, the development of sustained-release formulations of metformin hydrochloride is expected to enhance patient adherence and improve glycemic control[1].

Combination Therapies and Novel Indications

Combination therapies involving metformin and other antidiabetic agents, including rosiglitazone, are likely to remain a focus area. Additionally, research into novel indications for metformin, such as its potential use in treating prostate cancer when combined with enzalutamide, may expand its market scope[4].

Clinical Trials Update

Ongoing and Future Trials

Several clinical trials are ongoing to evaluate the safety and efficacy of metformin hydrochloride and rosiglitazone maleate in various settings. For example, a phase I trial is investigating the combination of metformin hydrochloride with enzalutamide in treating patients with hormone-resistant prostate cancer. This trial aims to determine the maximum tolerated dose and assess the feasibility and safety of this combination[4].

Safety and Adverse Effects

Gastrointestinal Adverse Reactions

Metformin hydrochloride is known to cause gastrointestinal adverse reactions, although the incidence is lower with sustained-release formulations. The combination of metformin with rosiglitazone does not significantly increase the risk of gastrointestinal adverse effects but may introduce other risks such as cardiovascular events[1][5].

Cardiovascular Risks

Rosiglitazone maleate has been associated with increased cardiovascular risks, particularly in elderly patients. This has led to careful monitoring and cautious use of this medication in high-risk populations[5].

Patient Adherence and Compliance

Once-Daily Formulations

The development of once-daily formulations, such as the combination of rosiglitazone and metformin, is expected to improve patient adherence. Simplified dosing regimens can enhance compliance, leading to better glycemic control and overall health outcomes[3].

Regulatory Environment

Approval and Guidelines

Both metformin hydrochloride and rosiglitazone maleate are approved by regulatory bodies such as the FDA for the treatment of T2DM. Clinical practice guidelines continue to emphasize the importance of glycemic control, and these medications are often recommended as part of comprehensive treatment plans[3][5].

Key Takeaways

• Metformin Hydrochloride: Remains a first-line treatment for T2DM due to its efficacy, safety, and cost-effectiveness.
• Rosiglitazone Maleate: Effective in combination with metformin but comes with cardiovascular risks, particularly in elderly patients.
• Combination Therapies: Enhance glycemic control and are likely to remain a focus area in future treatments.
• Emerging Trends: Sustained-release formulations and novel indications may expand the market scope for these drugs.
• Patient Adherence: Once-daily formulations can improve compliance and health outcomes.

FAQs

What is the primary use of metformin hydrochloride in clinical practice?

Metformin hydrochloride is primarily used as a first-line treatment for type 2 diabetes mellitus to lower blood glucose levels by reducing hepatic glucose production and increasing insulin sensitivity.

What are the benefits of combining rosiglitazone maleate with metformin hydrochloride?

Combining rosiglitazone maleate with metformin hydrochloride results in greater reductions in HbA1c levels, improves insulin sensitivity, and minimizes weight gain compared to monotherapy.

What are the potential risks associated with rosiglitazone maleate?

Rosiglitazone maleate is associated with increased cardiovascular risks, particularly in elderly patients, which necessitates careful monitoring and cautious use.

Are there ongoing clinical trials for new indications of metformin hydrochloride?

Yes, there are ongoing clinical trials, such as the phase I trial investigating the combination of metformin hydrochloride with enzalutamide in treating patients with hormone-resistant prostate cancer.

How do sustained-release formulations of metformin hydrochloride impact patient adherence?

Sustained-release formulations of metformin hydrochloride can improve patient adherence by reducing the frequency of dosing, which can lead to better glycemic control and overall health outcomes.

Sources

1. Frontiers in Endocrinology: "Comparison of Clinical Efficacy and Safety of Metformin Hydrochloride Sustained-Release (SR) Tablet (II) Produced by Dulening and the Original Metformin Hydrochloride Tablet Produced by Glucophage in the Treatment of Type 2 Diabetes Mellitus (T2DM)".
2. JAMA Internal Medicine: "A Meta-analysis Comparing the Effect of Thiazolidinediones on Glycemic Control in Patients with Type 2 Diabetes".
3. PubMed: "Rosiglitazone maleate + metformin hydrochloride extend".
4. ClinicalTrials.gov: "Enzalutamide and Metformin Hydrochloride in Treating Patients With Hormone-Resistant Prostate Cancer".
5. PharmaScience Inc.: "Rosiglitazone maleate/metformin hydrochloride".