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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR ACTOPLUS MET XR


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All Clinical Trials for ACTOPLUS MET XR

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT02917629 ↗ ACTOplus Met XR in Treating Patients With Stage I-IV Oral Cavity or Oropharynx Cancer Undergoing Definitive Treatment Terminated National Cancer Institute (NCI) Phase 2 2017-08-14 This randomized phase IIb trial studies how well ACTOplus met XR works in treating in patients with stage I-IV oral cavity or oropharynx cancer that are undergoing definitive treatment. Chemoprevention is the use of drugs to keep oral cavity or oropharynx cancer from forming or coming back. The use of ACTOplus met XR may slow disease progression in patients with oral cavity or oropharynx cancer.
NCT01800227 ↗ Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fasting Conditions Completed Torrent Pharmaceuticals Limited Phase 1 1969-12-31 Objective: subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days. Study Design: Randomized, Two-Way Crossover, Single-Dose, and Open-Label
NCT01800240 ↗ Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fed Conditions Completed Torrent Pharmaceuticals Limited Phase 1 1969-12-31 Objective: subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days. Study Design: Randomized, Two-Way Crossover, Single-Dose, and Open-Label
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for ACTOPLUS MET XR

Condition Name

21110-0.200.20.40.60.811.21.41.61.822.2HealthyStage I Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7Stage IVA Oropharyngeal Squamous Cell CarcinomaStage II Oral Cavity Squamous Cell Carcinoma[disabled in preview]
Condition Name for ACTOPLUS MET XR
Intervention Trials
Healthy 2
Stage I Oropharyngeal Squamous Cell Carcinoma AJCC v6 and v7 1
Stage IVA Oropharyngeal Squamous Cell Carcinoma 1
Stage II Oral Cavity Squamous Cell Carcinoma 1
[disabled in preview] 0
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Condition MeSH

11110-0.100.10.20.30.40.50.60.70.80.911.1Carcinoma, Squamous CellCarcinomaMalnutritionSquamous Cell Carcinoma of Head and Neck[disabled in preview]
Condition MeSH for ACTOPLUS MET XR
Intervention Trials
Carcinoma, Squamous Cell 1
Carcinoma 1
Malnutrition 1
Squamous Cell Carcinoma of Head and Neck 1
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Clinical Trial Locations for ACTOPLUS MET XR

Trials by Country

+
Trials by Country for ACTOPLUS MET XR
Location Trials
United States 4
India 2
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Trials by US State

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Trials by US State for ACTOPLUS MET XR
Location Trials
Wisconsin 1
New York 1
Minnesota 1
Maryland 1
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Clinical Trial Progress for ACTOPLUS MET XR

Clinical Trial Phase

33.3%66.7%0-0.200.20.40.60.811.21.41.61.822.2Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for ACTOPLUS MET XR
Clinical Trial Phase Trials
Phase 2 1
Phase 1 2
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Clinical Trial Status

66.7%33.3%0-0.200.20.40.60.811.21.41.61.822.2CompletedTerminated[disabled in preview]
Clinical Trial Status for ACTOPLUS MET XR
Clinical Trial Phase Trials
Completed 2
Terminated 1
[disabled in preview] 0
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Clinical Trial Sponsors for ACTOPLUS MET XR

Sponsor Name

trials000111112222Torrent Pharmaceuticals LimitedNational Cancer Institute (NCI)[disabled in preview]
Sponsor Name for ACTOPLUS MET XR
Sponsor Trials
Torrent Pharmaceuticals Limited 2
National Cancer Institute (NCI) 1
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Sponsor Type

66.7%33.3%0-0.200.20.40.60.811.21.41.61.822.2IndustryNIH[disabled in preview]
Sponsor Type for ACTOPLUS MET XR
Sponsor Trials
Industry 2
NIH 1
[disabled in preview] 0
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ACTOPLUS MET XR: Clinical Trials, Market Analysis, and Projections

Introduction

ACTOPLUS MET XR is a fixed-dose combination oral antidiabetic medication that combines pioglitazone and extended-release metformin. This medication is designed to improve glycemic control in adults with type 2 diabetes mellitus. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Mechanism of Action

ACTOPLUS MET XR combines two antihyperglycemic agents: pioglitazone, an insulin-sensitizing agent, and metformin, which decreases endogenous hepatic glucose production. Pioglitazone acts by enhancing peripheral glucose utilization and decreasing hepatic glucose output, while metformin reduces glucose production in the liver[2].

Clinical Studies

There have been no clinical efficacy studies conducted specifically with ACTOPLUS MET XR. However, the efficacy and safety of the separate components, pioglitazone and metformin, have been well established in various clinical trials. For example, the PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive) trial demonstrated the efficacy of pioglitazone in patients with type 2 diabetes and extensive macrovascular disease[4].

Safety and Warnings

Clinical trials and postmarketing reports have highlighted several safety concerns associated with ACTOPLUS MET XR. These include the risk of fluid retention and congestive heart failure, lactic acidosis, edema, hypoglycemia when used with insulin or insulin secretagogues, and hepatic effects such as liver injury and failure[1][2].

Market Analysis

Current Market Position

ACTOPLUS MET XR, introduced in 2010, was the first and only fixed-dose combination oral antidiabetic medication with extended-release metformin available in once-daily dosing. This unique formulation has positioned it as a convenient option for patients with type 2 diabetes, enhancing adherence to treatment regimens[5].

Market Trends

The diabetes market is growing due to the increasing prevalence of type 2 diabetes globally. However, the market for pioglitazone-containing medications has faced challenges due to safety concerns, particularly the risk of bladder cancer associated with pioglitazone. Despite these challenges, the convenience and efficacy of ACTOPLUS MET XR have maintained its relevance in the market[4].

Market Projections

Growth Factors

The diabetes management market is expected to grow significantly due to the rising incidence of diabetes and the need for effective and convenient treatment options. While ACTOPLUS MET XR faces competition from other antidiabetic medications, its unique formulation and established efficacy make it a viable choice for many patients.

Challenges

One of the significant challenges for ACTOPLUS MET XR is the ongoing scrutiny regarding the safety profile of pioglitazone. The FDA has updated labels to include warnings about the increased risk of bladder cancer, which may impact prescribing decisions and patient confidence[4].

Future Outlook

Despite the challenges, the market for antidiabetic medications is expected to continue growing. The convenience of once-daily dosing and the combination of two effective antihyperglycemic agents in ACTOPLUS MET XR will likely maintain its market presence. However, the drug's future success will depend on ongoing safety monitoring and the ability to address any emerging safety concerns.

Key Takeaways

  • Efficacy and Mechanism: ACTOPLUS MET XR combines pioglitazone and extended-release metformin to improve glycemic control in type 2 diabetes patients.
  • Clinical Trials: While no specific trials have been conducted for ACTOPLUS MET XR, the components have been extensively studied.
  • Safety Concerns: The drug carries risks such as fluid retention, lactic acidosis, and hepatic effects.
  • Market Position: It remains a convenient option for once-daily dosing, despite safety concerns.
  • Market Projections: The diabetes market is growing, but ACTOPLUS MET XR faces challenges due to safety issues.

FAQs

What are the main components of ACTOPLUS MET XR?

ACTOPLUS MET XR contains pioglitazone and extended-release metformin, both of which are antihyperglycemic agents used to manage type 2 diabetes[2].

What are the primary safety concerns associated with ACTOPLUS MET XR?

The primary safety concerns include fluid retention and congestive heart failure, lactic acidosis, edema, hypoglycemia, and hepatic effects such as liver injury and failure[1].

How does ACTOPLUS MET XR differ from other antidiabetic medications?

ACTOPLUS MET XR is unique because it combines pioglitazone and extended-release metformin in a once-daily dosing formulation, enhancing patient adherence[5].

What is the current market outlook for ACTOPLUS MET XR?

The market for ACTOPLUS MET XR is influenced by the growing need for effective diabetes management, but it faces challenges due to safety concerns associated with pioglitazone[4].

Are there any ongoing clinical trials or studies related to ACTOPLUS MET XR?

There are no specific ongoing clinical trials for ACTOPLUS MET XR, but ongoing safety monitoring and postmarketing surveillance continue to assess its safety profile[1].

How does the risk of bladder cancer impact the use of ACTOPLUS MET XR?

The risk of bladder cancer associated with pioglitazone has led to updated label warnings and may influence prescribing decisions, although the overall risk is still being monitored and assessed[4].

Sources

  1. Takeda Pharmaceuticals: ACTOPLUS MET XR Prescribing Information.
  2. FDA: ACTOPLUS MET and ACTOPLUS MET XR Label.
  3. GlobeNewswire: MET Targeting Therapies Market Set for Significant Growth by 2034.
  4. FDA: Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer.
  5. Takeda Pharmaceuticals: ACTOPLUS MET XR Now Available in Pharmacies Nationwide.

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