Competact

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Competact

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Method of action: Drugs Used In Diabets

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Competact

Property Description
Active Ingredients Metformin Hydrochloride, Pioglitazone Hydrochloride
Form Film-coated tablet
Pharmacological Class Oral Antihyperglycemic Agents (Biguanide and TZD combination)
Common Use Management of Type 2 Diabetes Mellitus
Origin Synthetic

What Type of Medicine is Competact?

Competact is a synthetic, prescription-only, fixed-dose combination product used as an Oral Antihyperglycemic Agent for adults with Type 2 Diabetes Mellitus. The drug is administered orally and is presented as a single film-coated tablet. The product is clinically recognized for its role in addressing the complex pathogenesis of T2DM by combining two distinct therapeutic approaches. Its structure, combining two active molecules into one tablet, simplifies the regimen compared to taking two separate monotherapy drugs.

Composition and Dual-Action Class

The Competact tablet combines two distinct active ingredients: Metformin Hydrochloride and Pioglitazone Hydrochloride. Metformin, the Biguanide component, is widely acknowledged for its ability to limit excess glucose release from the liver. Pioglitazone, belonging to the Thiazolidinedione (TZD) class, is a recognized insulin sensitizer. This fixed-dose combination structure is a key differentiator, as it leverages complementary mechanisms to address multiple metabolic faults simultaneously.

General Purpose and Therapeutic Goal

The general purpose of Competact is to improve overall glycemic control by helping to lower and stabilize elevated blood sugar concentrations. The medication is typically prescribed to adult patients whose blood sugar remains high despite receiving treatment with Metformin alone. This dual-action mechanism is designed to provide a comprehensive and sustained approach to managing blood sugar concentrations by targeting both the liver's output and the tissue's utilization of glucose.

Regulatory References

  1. Competact (Pioglitazone/Metformin) Drug Information
  2. Competact EPAR Summary

What side effects are possible with Competact ?

Official Classification of Possible Side Effects

The safety profile of Competact (Metformin/Pioglitazone) is based on the documented adverse reactions of both active components, classified by frequency and System-Organ Class (SOC) in regulatory documents.

Very Common adverse reactions include Gastrointestinal Disorders such as diarrhea, nausea, vomiting, and abdominal pain. These effects are often associated with the Metformin component and are more likely to appear at the start of treatment.

Common adverse reactions include an increased weight and oedema (swelling), primarily related to Pioglitazone, along with documented cases of bone fracture, particularly in female patients.

Serious Adverse Reactions and Safety Constraints

The regulatory labeling highlights rare but serious safety concerns.

  • Lactic Acidosis: A very rare, life-threatening metabolic complication associated with the Metformin component. The risk increases with certain pre-existing conditions, notably severe renal impairment, which is an absolute contraindication.
  • Heart Failure: The Pioglitazone component can cause fluid retention that may lead to or exacerbate congestive heart failure. The medicine is contraindicated in patients with established New York Heart Association (NYHA) Class III or IV heart failure.

Population and Duration-Related Safety

Official documents specify that the medicine is also contraindicated in patients with established hepatic impairment. The label also notes that long-term exposure (use for more than one year) may be associated with an increased risk of bladder cancer.

Classification System-Organ Class (SOC) Examples
Very Common Gastrointestinal Disorders
Common Musculoskeletal and Connective Tissue Disorders
Very Rare Metabolic and Nutritional Disorders

Overdose and Emergency Response

Overdose and when to seek help

The primary risk associated with Competact overdose is Lactic Acidosis, a very rare but serious metabolic complication stemming from the Metformin component. Lactic Acidosis is classified as a medical emergency that requires immediate treatment in a hospital setting.


Documented Manifestations and Emergency Action

Clinical signs officially documented for Lactic Acidosis include acidotic dyspnoea (difficulty breathing), abdominal pain, muscle cramps, asthenia (severe tiredness), hypothermia, and a reduced heartbeat. Progression of Lactic Acidosis may result in coma. If any of these symptoms are suspected, the medication must be stopped immediately. Regulatory authorities mandate that the patient seek immediate medical attention.

Overdose may also manifest as hypoglycemia (low blood sugar). Pioglitazone overdose, even at doses up to 180 mg/day, was reported as asymptomatic in one clinical trial.


Management and Risk Factors

No specific antidotes are available for Metformin toxicity. Management is defined by supportive measures, including administering sugar for hypoglycemia. For severe Lactic Acidosis, Hemodialysis is the documented procedure recommended for clearing Metformin from the body. The regulatory labeling notes that the risk for Lactic Acidosis is increased by existing or worsening renal function.

Therapeutic Uses of Competact

What Competact Treats: Main Uses and Benefits

Competact is commonly used to help with certain distressing symptoms related to persistently elevated blood sugar in adults diagnosed with Type 2 Diabetes Mellitus (T2DM). The primary therapeutic domain is relevant in contexts involving heightened systemic burden in adult patients whose blood sugar levels remain elevated following prior treatment with Metformin. This aligns with therapeutic areas involving heightened responses in blood glucose regulation.

Addressing Inadequate Glycemic Control

This medication is generally applied in clinical settings that involve unstable symptom patterns related to inadequate glycemic control, where blood sugar levels are elevated following prior treatment. It is specifically intended for patients whose T2DM symptoms are not satisfactorily managed by oral Metformin monotherapy alone. The central benefit provides support that helps ease the overall symptom burden of inadequate glycemic control.

Managing Symptom Clusters Related to Imbalance

Competact generally plays a role in managing the core underlying symptomatic patterns of T2DM. It is relevant when symptoms are associated with systemic or localized discomfort linked to organ-specific functional stress. The medication helps address symptom clusters that may become intense or disruptive, assisting with maintaining functional stability during symptomatic phases.


Quick Fact: Supportive Management for Elevated Blood Sugar

Regulatory References

  1. European Medicines Agency (EMA) Summary of Product Characteristics

Eligibility and Restrictions for Use

Competact is officially indicated for use only in adult patients with Type 2 Diabetes Mellitus whose blood sugar remains inadequately controlled on Metformin monotherapy.


Official Contraindications

Regulatory documents explicitly prohibit the use of Competact in patients with:

  • Cardiac failure or a history of heart failure (NYHA Class I–IV).
  • Severe renal dysfunction (creatinine clearance < 60 mL/min or eGFR < 30 mL/min/1.73 m^2).
  • Hepatic impairment (active liver disease).
  • Current bladder cancer or a history of bladder cancer, and uninvestigated macroscopic haematuria.
  • Acute metabolic acidosis, including diabetic ketoacidosis, or conditions causing tissue hypoxia (e.g., recent heart attack, respiratory failure).

Eligibility Restrictions

  • Age: Use is not recommended in children and adolescents under 18 years of age as safety and efficacy have not been established. Patients over 75 years require special caution.
  • Pregnancy & Lactation: The medicine must not be used by women who are breast-feeding and is not recommended during pregnancy.
  • Conditional Use: Competact must be temporarily discontinued during acute illnesses, such as severe infection or dehydration, that may compromise kidney function.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Pharmacokinetic and Exposure-Altering Interactions

The interaction profile of Competact (Pioglitazone/Metformin) is significantly influenced by substances that alter the clearance of its two active components. Co-administration with strong CYP2C8 inhibitors, such as Gemfibrozil, results in an increase in pioglitazone plasma concentrations. Conversely, CYP2C8 inducers, including Rifampin, lead to a decrease in pioglitazone exposure. The metformin component's clearance is affected by medicines that compete for renal tubular transport systems. Drugs such as Ranolazine, Vandetanib, Dolutegravir, and Cimetidine are documented to increase metformin accumulation by reducing its renal clearance.

Pharmacodynamic Effects and Restrictions

Combinations with other glucose-lowering agents, including Insulin or Sulfonylureas, carry an officially documented additive risk of hypoglycemia. Additionally, the label notes that the use of this medicine is associated with a decrease in the absorption and serum levels of Vitamin B12. Excessive alcohol intake is classified as a significant restriction due to the potentiation of metformin's effect on lactate metabolism, which substantially increases the risk of lactic acidosis.

Procedural and Population Constraints

A mandatory timing rule requires the medicine to be temporarily discontinued before or at the time of any procedure involving Iodinated Contrast Media, and to be withheld for 48 hours following the procedure. Furthermore, the official label notes that age 65 years and older is a factor that heightens the risk of metformin-associated lactic acidosis, related to potential changes in renal function.

Mechanism of Action

How Competact Works

The action of Competact results from the utilization of its two components, Pioglitazone and Metformin, each targeting distinct but complementary processes in glucose metabolism.

Modulating Insulin Action via Nuclear Receptors

This domain covers the action of Pioglitazone, a highly selective agonist that binds to Peroxisome Proliferator-Activated Receptor gamma (PPAR-gamma) . This interaction modulates the transcription of key genes involved in glucose and lipid metabolism, which in turn increases the sensitivity of muscle, fat, and liver cells to circulating insulin. This promotes the uptake of glucose from the plasma by peripheral tissues.

Inhibiting Hepatic Glucose Production

This domain describes the primary role of Metformin, which is to reduce the amount of glucose the liver releases into the blood. Metformin is associated with the activation of AMP-activated protein kinase (AMPK), an enzyme that subsequently inhibits the cascade of processes responsible for hepatic gluconeogenesis (glucose production). This mechanism contributes to a reduction of baseline glucose flux into the plasma.

Complementary Dual-Pathway Regulation

The two distinct mechanisms—increasing insulin's effect on peripheral tissues and suppressing glucose release from the liver—work together to facilitate multiple-pathway metabolic modulation. This complementary dual-pathway approach engages mechanisms that regulate overactive processes in both peripheral and central metabolic organs, contributing to regulation of systemic glucose flux.

Dosage and Administration Information

Competact (pioglitazone/metformin) tablets must be taken exactly as prescribed by your physician.

General Administration Guidelines

  • Dose: The typical recommended dose is one tablet twice a day (providing a total of 30 mg pioglitazone and 1,700 mg metformin hydrochloride daily). Your doctor will determine the appropriate starting and maintenance dose, especially if you are switching from metformin monotherapy or have other risk factors, such as those for congestive heart failure.
  • Method: Swallow the tablets whole with a glass of water. Do not crush, break, or chew them.
  • Timing: Take the tablet with or just after food to help minimize potential gastrointestinal side effects associated with metformin.

Monitoring and Special Populations

  • Treatment Review: Your doctor should review the adequacy of your treatment response, often by assessing your HbA1c levels, after 3 to 6 months of starting therapy, and periodically thereafter to confirm the sustained benefit. If there is an inadequate response, the medicine should be discontinued.
  • Kidney Function: Because metformin is eliminated by the kidneys, your doctor will assess your Glomerular Filtration Rate (GFR) before starting treatment and at least annually thereafter. Monitoring frequency may be increased, particularly for elderly patients or those at risk of worsening kidney function.
  • Liver Function: Blood tests to monitor liver enzyme levels will be requested periodically during your treatment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Competact


Evidence for Inadequate Blood Sugar Control in Type 2 Diabetes

The research for Competact, which combines metformin and pioglitazone, was studied for conditions characterized by fluctuating or episodic manifestations in adults with Type 2 Diabetes. These investigations primarily focused on patients whose blood sugar levels remained elevated after receiving treatment with metformin alone. The studies used Randomized Controlled Trials (RCTs) and were relevant in trials assessing short-term or episodic symptom patterns.

Researchers primarily monitored outcomes related to systemic or functional imbalance, such as the blood sugar biomarker Glycated Hemoglobin (HbA1c) and Fasting Plasma Glucose (FPG). Short-term and intermediate trials reported how symptoms evolved in the observed populations. These studies contribute to the broader evidence landscape by measuring changes in these key biomarkers. Regulatory studies also showed the fixed-dose combination tablet was bioequivalent—meaning it delivers the active ingredients in the same way—as taking the two individual medicines separately.


Long-Term Studies and Durability of Research

Research was studied for extended periods, and studies monitored outcomes related to outcomes reflecting daily functioning or activity level and tracking long-term observations. These long-term effects are not fully established specifically for the fixed-dose combination tablet, as most of this extended data is extrapolated from larger, dedicated trials that studied the pioglitazone component as a separate medicine. The long-term evidence is limited in providing full insight into the durability of metabolic changes over many years, as most combination research follow-up durations were limited to one year or less.


Understanding the Certainty and Gaps in Research

The evidence consistency remains limited and heterogeneous in certain studies, and the data for short-term blood sugar changes may show consistency among the target population. Key limitations include the fact that the follow-up durations were limited for the specific combination tablet. Also, while the fixed-dose combination was evaluated in adults, comparative evidence is lacking for certain special populations, such as very older adults. Research provides context but not individual predictions; findings describe group patterns and evidence highlights what is known—and what is still uncertain—about the use of Competact.

Key Studies & References PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive): secondary prevention of macrovascular events in patients with type 2 diabetes

Frequently Asked Questions (FAQ)

Common questions about Competact (FAQ)


Q: How quickly should I expect Competact to start working?

A: Official documents state that the adequacy of your blood sugar control should be reviewed by your doctor after three to six months of starting therapy. While individual responses may vary, official follow-up periods are established to confirm the sustained response to the treatment.


Q: Is it safe to drink alcohol while taking Competact?

A: Regulatory documents state that excessive alcohol intake must be avoided while taking this medication. The combination of metformin (one of the components) and excessive alcohol can significantly increase the risk of a rare but serious metabolic complication called lactic acidosis. Guidance on social or moderate alcohol consumption requires discussion with a healthcare provider.


Q: How does Competact compare to taking pioglitazone and metformin separately?

A: Regulatory studies have shown that the fixed-dose combination tablet is bioequivalent, meaning it delivers the active ingredients to the body in the same way as taking the two individual medicines separately. The fixed-dose combination structure is intended to offer a simplified regimen when both active substances are medically appropriate.


Q: Does Competact have a 'black box warning' in the US?

A: The US Food and Drug Administration (FDA) requires a Boxed Warning—often called a 'black box warning'—for this product. This prominent warning highlights the risk of Congestive Heart Failure and Lactic Acidosis associated with the components of the medicine. These serious safety concerns are highlighted in the labeling, providing context for discussion with a healthcare provider.


Q: Is Competact a type of insulin?

A: No, Competact is not a type of insulin. It belongs to a class of medicines known as Oral Antihyperglycemic Agents. It is a combination product that works by using two active ingredients to help the body use the insulin it already produces more effectively and by decreasing the amount of glucose the liver releases into the blood.


Q: If I miss a dose of Competact, what is the generally recommended action?

A: Official patient information generally advises that if a dose is missed, you should not double the dose the following day. Instead, you should simply take your next scheduled dose as usual. Patients are generally advised to follow the directions provided by their healthcare professional regarding missed doses.


Q: What happens if I stop taking Competact suddenly?

A: Official patient information advises against stopping the medicine without first discussing it with a healthcare provider. Stopping treatment may lead to a loss of blood sugar control and subsequent high blood sugar (hyperglycemia).


Q: Are there any major diet restrictions while taking Competact?

A: Official information emphasizes the need to avoid excessive alcohol intake due to safety risks. Beyond this restriction, the medicine is simply recommended to be taken with or just after food to help minimize potential stomach side effects. It is indicated for use alongside a prescribed diet and exercise plan.


Q: Does Competact interact with over-the-counter pain relievers like ibuprofen?

A: The official product information lists that certain drug classes, including some that contain non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, can potentially increase the risk of lactic acidosis by affecting kidney function. Your healthcare provider should be informed of all over-the-counter medications and supplements you take.


Q: What is the half-life of Competact in the body?

A: The components of Competact have different half-lives. The pioglitazone component has an approximate average plasma half-life of 3 to 7 hours, with its active metabolites lasting longer. The metformin component has an approximate elimination half-life of 6.2 hours in plasma. The half-life describes the time it takes for half of the substance to be eliminated from the body.


Q: Can Competact cause low blood sugar (hypoglycemia)?

A: The metformin component is generally described as having a low risk of causing low blood sugar (hypoglycemia) when used alone. However, official documents note that the risk of low blood sugar is increased when Competact is used in combination with other anti-diabetic medications, such as insulin or sulfonylureas.


Q: Is it common for people to feel nauseous when starting Competact?

A: Yes, nausea is listed as a very common adverse reaction, which is mostly associated with the metformin component. Official documents indicate that these types of gastrointestinal side effects occur most frequently during the initiation of therapy and official information indicates these effects typically diminish with continued use.


Q: Can Competact cause joint pain or muscle stiffness?

A: Official documents list Arthralgia (joint pain) as a common adverse reaction for the pioglitazone component of the medicine. Additionally, a common adverse reaction reported is bone fracture, particularly in female patients.


Q: Does Competact have any known interactions with herbal supplements?

A: Regulatory documents primarily detail interactions with prescription medicines. While some herbal supplements, such as those that impact blood glucose, may require caution, specific interactions are not comprehensively listed in core labels. It is always recommended to disclose all herbal supplements to your healthcare provider.


Q: Do studies suggest Competact affects cholesterol levels?

A: Clinical trials reported that the pioglitazone component generally resulted in mean decreases in serum triglycerides and mean increases in HDL ('good') cholesterol. These studies did not report a consistent mean change in LDL and total cholesterol.


Q: What is the maximum duration people typically take Competact?

A: Official documents do not set a maximum duration of use but stress the importance of periodic treatment review by a healthcare provider to confirm sustained benefit. It is noted that the risk of bladder cancer may be increased with long-term exposure, which is defined as use for more than one year.


Q: What is the typical starting dosage strength for Competact?

A: Official prescribing information describes the usual daily dose as a combination providing 30 mg of pioglitazone and 1700 mg of metformin, typically taken as one 15 mg/850 mg tablet twice daily. Official guidance indicates that a healthcare provider assesses the appropriate starting dose based on an individual's prior treatment and needs.


Q: Is Competact generally more effective than lifestyle changes alone?

A: The medicine is officially indicated for use as an adjunct to diet and exercise for blood sugar management. Clinical studies evaluated its effect as an addition to existing therapies, rather than as a comparison to lifestyle changes as a sole treatment option.


Q: Can Competact affect eye health or vision?

A: Official documents list visual disturbance as a common adverse reaction. This is often reported early in treatment and is generally thought to be related to temporary changes in the lens of the eye caused by fluctuations in blood sugar levels.


Q: Does Competact cause fatigue or tiredness?

A: Fatigue or tiredness is not listed as a routine common side effect in official documents. However, it is noted as a potential symptom of several serious conditions related to the drug, such as heart failure or lactic acidosis.


Q: Can Competact be crushed or split?

A: Official patient instructions state that the tablets must be swallowed whole with water. Crushing, breaking, or chewing them is advised against to ensure the proper administration of the medicine.


Q: Are there any restrictions on driving or operating machinery while on Competact?

A: The medicine is not expected to impair the ability to drive or use machines. However, official information advises caution if a patient experiences side effects like abnormal vision while taking the medication.

How should Competact be stored and disposed of?

How to Store and Dispose of Competact

Competact (pioglitazone/metformin) must be stored under specific environmental constraints to maintain stability, as required by regulatory labeling.

Storage Conditions

The tablets must be stored at room temperature, typically 20 C to 25 C (68 F to 77 F). The medicine must be kept in a closed container and requires protection from heat, moisture, and light. It is prohibited to freeze the product. For safety, Competact must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Competact should not be disposed of via wastewater. Preferred disposal methods include returning the medicine to a drug take-back program or pharmacy for proper handling. If no collection program is available, the product may be mixed with an undesirable substance and placed in the household trash, following national or local waste requirements.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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