Competact

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Competact on Prescriptsy

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Competact is a fixed-dose combination tablet containing pioglitazone 15 mg and metformin hydrochloride 850 mg, licensed in the United Kingdom for the treatment of type 2 diabetes mellitus in adults whose blood glucose is not adequately controlled by metformin alone.

Type 2 diabetes affects over 4 million people in the UK and remains one of the most significant public health challenges, contributing to cardiovascular disease, kidney failure, vision loss, and lower-limb amputations.

Effective glycaemic control substantially reduces the risk of these complications.

Competact addresses the two central metabolic defects of type 2 diabetes, namely insulin resistance and excessive hepatic glucose production, through complementary pharmacological mechanisms combined in a single tablet.

This page provides a detailed clinical overview of Competact, covering how the medicine works, who it is suitable for, correct dosage, expected benefits, side effects, important safety warnings, monitoring requirements, and how to obtain a prescription in the United Kingdom.

Important safety information about Competact

Before reading further, note the following essential safety points. Competact is a prescription-only medicine (POM) and must only be taken under medical supervision.

• Competact must not be used if you have heart failure or a history of heart failure. Pioglitazone can cause fluid retention that may worsen cardiac function.
• Lactic acidosis is a rare but potentially fatal complication of metformin. Seek emergency help if you develop rapid breathing, severe abdominal pain, muscle cramps, or feel very unwell.
• Stop Competact 48 hours before and after any medical procedure involving iodinated contrast media (contrast dye used in certain scans).
• Report any blood in the urine or new urinary symptoms to your doctor promptly, as a small increased risk of bladder cancer has been observed with pioglitazone.
• Do not take Competact if you have severe kidney impairment, liver disease, or diabetic ketoacidosis.

Understanding type 2 diabetes and insulin resistance

Type 2 diabetes develops when the body becomes resistant to the effects of insulin and the pancreas cannot produce enough insulin to overcome this resistance.

Insulin is the hormone that enables cells in muscles, fat, and the liver to take up glucose from the bloodstream for energy.

When insulin resistance is present, glucose accumulates in the blood, leading to chronically elevated blood sugar levels (hyperglycaemia).

The liver plays a central role in this process. In healthy individuals, insulin suppresses hepatic glucose production between meals and overnight.

In type 2 diabetes, the liver overproduces glucose because it fails to respond appropriately to insulin signalling.

At the same time, skeletal muscle, the largest consumer of glucose in the body, takes up less glucose because of impaired insulin-stimulated glucose transport.

Adipose tissue also becomes insulin-resistant, releasing excessive free fatty acids that further impair insulin signalling in muscle and liver.

This combination of peripheral insulin resistance and hepatic glucose overproduction is the metabolic hallmark of type 2 diabetes, and it is precisely what Competact is designed to address.

The dual-action approach targets both defects simultaneously, which is why combination therapy often succeeds where single-agent treatment falls short.

How Competact works: mechanism of action

Competact contains two active substances with complementary mechanisms of action.

Pioglitazone: thiazolidinedione insulin sensitiser

Pioglitazone is a selective agonist of peroxisome proliferator-activated receptor gamma (PPAR-gamma), a nuclear receptor expressed predominantly in adipose tissue but also in skeletal muscle and liver.

Activation of PPAR-gamma modulates the transcription of a number of insulin-responsive genes involved in glucose and lipid metabolism.

In adipose tissue, pioglitazone promotes the differentiation of small, insulin-sensitive adipocytes and enhances lipid storage in subcutaneous rather than visceral depots.

This redistribution reduces the release of free fatty acids and inflammatory cytokines (such as tumour necrosis factor-alpha and interleukin-6) that impair insulin signalling in other tissues.

In skeletal muscle, the reduction in circulating free fatty acids and inflammatory mediators restores insulin-stimulated glucose transport via GLUT4 translocation.

In the liver, pioglitazone reduces hepatic fat content and improves insulin-mediated suppression of gluconeogenesis.

The net effect is a measurable improvement in whole-body insulin sensitivity.

HbA1c reductions of 0.5 to 1.5 percentage points have been demonstrated in clinical trials, with additional benefits including reduced fasting insulin levels, improved lipid profiles (raised HDL cholesterol, reduced triglycerides), and reduced markers of systemic inflammation.

Metformin: biguanide

Metformin remains the first-line pharmacological treatment for type 2 diabetes worldwide.

Its primary action is to reduce hepatic glucose output by inhibiting gluconeogenesis and, to a lesser extent, glycogenolysis.

The molecular mechanism involves activation of AMP-activated protein kinase (AMPK), a cellular energy sensor that enhances insulin signalling and glucose uptake in peripheral tissues.

Metformin also improves insulin sensitivity in skeletal muscle and slows intestinal glucose absorption.

Unlike sulphonylureas, metformin does not stimulate insulin secretion from the pancreas and therefore carries no intrinsic risk of hypoglycaemia when used as monotherapy.

It is also weight-neutral or modestly weight-reducing, which is a significant advantage in a condition strongly associated with obesity.

Complementary dual action

When pioglitazone is combined with metformin, the two agents address different facets of insulin resistance simultaneously.

Metformin primarily targets hepatic glucose overproduction, while pioglitazone improves peripheral glucose disposal and modulates adipose tissue metabolism.

This complementary approach typically produces a greater reduction in HbA1c than either agent alone, while avoiding the risk of hypoglycaemia associated with insulin secretagogues.

Clinical evidence and UK prescribing guidance

The efficacy of pioglitazone in combination with metformin has been established in multiple randomised controlled trials.

The PROactive study, a large cardiovascular outcome trial, demonstrated that pioglitazone reduced the composite secondary endpoint of all-cause mortality, non-fatal myocardial infarction, and stroke in patients with type 2 diabetes and macrovascular disease.

The NICE guideline NG28 (Type 2 diabetes in adults: management) recommends considering pioglitazone as a second-line add-on therapy to metformin when a sulphonylurea is not appropriate, particularly in patients at significant risk of hypoglycaemia.

Competact offers the practical advantage of combining both medicines in a single tablet, reducing pill burden and supporting adherence.

Medication adherence is a recognised challenge in diabetes management, and fixed-dose combinations have been shown to improve compliance compared with taking multiple separate tablets.

Who is Competact suitable for?

Competact is indicated for adults with type 2 diabetes who are already taking metformin at a dose of at least 1700 mg daily and who require additional glucose-lowering therapy.

It is particularly appropriate for patients in whom a sulphonylurea is not suitable due to the risk of hypoglycaemia (for example, those with irregular meal patterns, older adults, or people in safety-critical occupations such as driving).

Competact is not suitable for patients with type 1 diabetes, diabetic ketoacidosis, heart failure (NYHA Class I to IV), significant hepatic impairment, severe renal impairment (eGFR below 30), active or previous bladder cancer, uninvestigated macroscopic haematuria, or conditions predisposing to lactic acidosis.

Dosage and administration

Take one Competact tablet twice daily, with or immediately after meals.

Each tablet provides pioglitazone 15 mg and metformin 850 mg, giving a total daily dose of pioglitazone 30 mg and metformin 1700 mg.

Tablets should be swallowed whole with water. Taking the medicine with food helps to minimise gastrointestinal side effects from metformin.

Your prescriber will review your response to treatment by measuring HbA1c at least every 3 to 6 months.

The therapeutic effect of pioglitazone develops gradually, with maximum glucose-lowering benefit typically seen after 3 to 6 months.

Early discontinuation before allowing adequate time for the medicine to work may lead to inappropriate treatment changes.

If you miss a dose, take it as soon as you remember, unless it is close to the time of your next dose. Never take a double dose. If you frequently forget doses, speak to your pharmacist about adherence aids.

Stopping Competact before medical procedures

You must stop Competact 48 hours before any procedure involving iodinated contrast media (such as CT scans with contrast dye or coronary angiography).

Contrast agents can temporarily impair kidney function, which may lead to metformin accumulation and lactic acidosis.

Your doctor will check your kidney function before restarting treatment, usually 48 hours after the procedure.

Side effects of Competact

Common side effects

Common side effects include weight gain (typically 2 to 4 kg in the first year, primarily from the pioglitazone component), peripheral oedema (swelling of the ankles and feet), gastrointestinal disturbances (nausea, diarrhoea, abdominal discomfort, reduced appetite, and metallic taste from the metformin component), headache, and upper respiratory tract infections.

Many gastrointestinal effects improve with continued use, particularly if the medicine is taken with meals.

Uncommon and rare side effects

Uncommon effects include dizziness, visual disturbance, joint pain, insomnia, flatulence, and a reduction in haemoglobin (due to plasma volume expansion with pioglitazone). Rare but serious adverse effects require particular attention.

Heart failure may develop or worsen because pioglitazone causes fluid retention.

Warning signs include increasing breathlessness (especially on exertion or when lying flat), rapid unexplained weight gain of more than 2 kg in a week, and progressive ankle swelling.

If these symptoms occur, stop the medicine and seek medical advice immediately.

Lactic acidosis is an extremely rare but potentially fatal metabolic emergency associated with metformin.

It occurs most often in the context of acute kidney injury, severe dehydration, sepsis, liver failure, or excessive alcohol intake.

Symptoms include hyperventilation, abdominal pain, muscle cramps, hypothermia, and a general feeling of being very unwell. If you suspect lactic acidosis, call 999 or go to A&E immediately.

An increased incidence of bone fractures, particularly in women, has been observed with pioglitazone.

Fractures typically affect the distal forearm, hand, and foot rather than the hip or spine.

Postmenopausal women with additional risk factors for osteoporosis should discuss this with their prescriber.

A small increased risk of bladder cancer has been associated with pioglitazone in some epidemiological studies.

While the absolute risk is low, any haematuria (blood in the urine) or new urinary symptoms such as urgency, frequency, or pelvic discomfort should be reported and investigated without delay.

When to seek urgent medical advice

Stop taking Competact and seek emergency care (call 999 or attend A&E) if you experience rapid or laboured breathing, severe abdominal pain with nausea or vomiting, muscle cramps with general malaise, significant sudden weight gain with breathlessness, or blood in the urine.

Contact your GP or NHS 111 if you develop persistent gastrointestinal symptoms, unexplained fatigue, visual changes, or any new symptoms that concern you.

Report all suspected adverse reactions to the MHRA via the Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Heart failure

Pioglitazone is contraindicated in patients with heart failure of any severity (NYHA Class I to IV).

Fluid retention caused by PPAR-gamma activation in the renal collecting ducts can precipitate or exacerbate heart failure.

Before starting Competact, your prescriber should assess your cardiovascular history and examine for signs of fluid overload.

If you develop symptoms of heart failure during treatment, the medicine must be stopped immediately.

Lactic acidosis and renal function

Metformin is eliminated unchanged by the kidneys. When renal function is impaired, metformin accumulates and the risk of lactic acidosis increases.

Competact is contraindicated when eGFR falls below 30 mL/min/1.73 m2, and caution is advised when eGFR is between 30 and 45.

Renal function should be checked before starting treatment, at least annually in patients with normal renal function, and at least every 3 to 6 months in patients with eGFR approaching the lower threshold or with risk factors for renal decline.

Acute conditions that impair kidney function, such as severe dehydration, vomiting, diarrhoea, or sepsis, should prompt temporary discontinuation of Competact.

Liver function

Rare cases of hepatic dysfunction have been reported with pioglitazone. Liver function tests (ALT) should be checked before initiating treatment and periodically during treatment.

Do not start Competact if ALT exceeds 2.5 times the upper limit of normal.

Discontinue treatment if ALT rises above 3 times the upper limit or if clinical signs of liver disease (jaundice, dark urine, fatigue, right upper quadrant pain) develop.

Bladder cancer risk

The MHRA has reviewed evidence suggesting a possible small increased risk of bladder cancer with pioglitazone.

Prescribers should assess bladder cancer risk factors (age, smoking, previous pelvic radiation, cyclophosphamide exposure) before starting treatment.

Pioglitazone should not be prescribed to patients with active bladder cancer, a history of bladder cancer, or uninvestigated macroscopic haematuria.

Fracture risk in women

Long-term pioglitazone use has been associated with an increased rate of fractures in women, particularly affecting distal limb bones. This risk should be considered when treating postmenopausal women or those with additional osteoporosis risk factors.

Drug interactions

Metformin interacts with medicines that affect renal function, including NSAIDs, ACE inhibitors, ARBs, and diuretics. Iodinated contrast media require temporary discontinuation.

Excessive alcohol intake increases the risk of lactic acidosis and should be avoided. Gemfibrozil (a fibrate) increases pioglitazone exposure through CYP2C8 inhibition, and the combination should be avoided.

Rifampicin induces CYP2C8 and reduces pioglitazone levels, potentially reducing efficacy.

Monitoring during treatment

Effective management of type 2 diabetes requires regular monitoring alongside pharmacological treatment. While taking Competact, your healthcare team should check the following at recommended intervals.

• HbA1c: every 3 to 6 months, to assess glycaemic control and treatment response.
• Renal function (eGFR and creatinine): at least annually, or more frequently if eGFR is declining or risk factors are present.
• Liver function (ALT): before starting treatment and periodically thereafter.
• Body weight: at each review, noting any significant or rapid gain that may indicate fluid retention.
• Signs and symptoms of heart failure: at each consultation, including assessment for oedema, breathlessness, and exercise tolerance.
• Foot examination and retinal screening: annually, as part of routine diabetes care.

How to get a Competact prescription in the UK

Competact is a prescription-only medicine available through the NHS.

Your GP or diabetes specialist can prescribe it following a review of your current diabetes management, HbA1c level, renal and hepatic function, cardiovascular history, and other relevant risk factors.

Authorised online prescribers registered with the General Pharmaceutical Council (GPhC) may also issue prescriptions following a structured clinical assessment.

The standard NHS prescription charge in England is currently 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Many people with diabetes in England are also eligible for a medical exemption certificate (form FP92A), which provides free NHS prescriptions for all medicines.

Living with type 2 diabetes: complementary measures

Competact works best as part of a comprehensive diabetes management plan.

Dietary modification, regular physical activity, weight management, and smoking cessation all contribute to better glycaemic control and reduced cardiovascular risk.

The NHS Diabetes Prevention Programme and local diabetes education courses such as DESMOND (Diabetes Education and Self-Management for Ongoing and Newly Diagnosed) provide structured support.

Blood glucose self-monitoring may be recommended depending on your treatment plan and individual circumstances.

When to seek medical advice

Contact your GP or NHS 111 if your blood sugar control deteriorates despite taking Competact as prescribed, if you develop persistent gastrointestinal symptoms, unexplained weight gain, ankle swelling, or any new symptoms.

Seek emergency care (call 999 or attend A&E) if you develop symptoms suggestive of lactic acidosis (rapid breathing, severe abdominal pain, muscle cramps, feeling very unwell) or heart failure (severe breathlessness, inability to lie flat).

Report any adverse reactions via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Sources

• Competact 15 mg/850 mg Film-Coated Tablets, Summary of Product Characteristics (EMC)
• Pioglitazone with metformin, British National Formulary (BNF)
• NICE NG28: Type 2 diabetes in adults: management
• Type 2 diabetes, NHS
• MHRA Yellow Card Scheme