What is Competact?
Competact comes in the form of oblong white tablets containing two active substances, pioglitazone (15 mg) as hydrochloride and metformin hydrochloride (850 mg).
What is Competact used for?
Competact is used in patients (especially those who are overweight) with non-insulin-dependent diabetes (type 2 diabetes). Competact is used in patients who are not sufficiently controlled on metformin alone (an antidiabetic medicine) at maximum doses. The medicine can only be obtained with a prescription.
How is Competact used?
The normal dose of Competact is one tablet taken twice a day. Patients switching from metformin to Competact alone may need to slowly introduce pioglitazone until a dose of 30 mg per day is reached. When needed, it is possible to switch directly from metformin to Competact. Taking Competact with or shortly after meals may reduce stomach problems caused by metformin. In older patients, kidney function should be monitored regularly.
How does Competact work?
Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of glucose in the blood. Competact contains two active ingredients that each have a different action. Pioglitazone makes cells (in adipose tissue, muscles and liver) more sensitive to insulin, thus making the body use the insulin it produces better. . Metformin basically inhibits the production of glucose and reduces its absorption in the intestine. The result of the combined action of the two active ingredients is a reduction in the glucose present in the blood, which helps to control type 2 diabetes.
How has Competact been studied?
Pioglitazone alone has been approved by the European Union as Actos, to be used together with metformin in the treatment of type 2 diabetes in patients in whom metformin alone does not give sufficient control. Studies of Actos used in combination with metformin but as separate tablets have been used to support the use of Competact for the same indications. These studies lasted from 4 months to two years and 1 305 patients took the combined dose. These studies measured the concentration in the blood of a substance (HbA1c) which gives an "indication of the effectiveness of blood glucose control."
What benefit has Competact shown during the studies?
In all studies, adding 30 mg of pioglitazone to metformin improved blood sugar control, with HbA1c levels further decreasing from 0.64 to 0.89% compared to levels obtained with alone. metformins.
What are the risks associated with Competact?
The most common side effects of Competact (seen in between 1 and 10 patients in 100) are anemia (low red blood cell count), visual disturbances, weight gain, arthralgia (joint pain), headache, hematuria (blood in the urine ), erectile dysfunction (problems getting an "erection). For a complete list of side effects reported with Competact, see the package leaflet. Competact should not be used in patients who are allergic to pioglitazone, metformin or any of the other ingredients of the medicine, nor in patients with heart failure or liver or kidney problems. Competact should not be used in patients with a disease that causes tissue oxygen deficiency such as a recent heart attack or shock. Competact should not be used in alcohol intoxication , diabetic ketoacidosis (high ketone levels), conditions that can affect the kidneys and during breastfeeding. For the complete list of restrictions, see the package insert.
Why has Competact been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that the efficacy of pioglitazone and metformin in type 2 diabetes has been demonstrated and that Competact simplifies treatment and improves compliance when a combination of the active substances is required. It decided that Competact's benefits outweigh its risks for the treatment of type 2 diabetes. The CHMP therefore recommended that Competact be given a marketing authorization.
Other information about Competact:
On 28 July 2006, the European Commission granted Takeda Global Research and Development Center (Europe) Ltd a "Marketing Authorization" for Competact, valid throughout the European Union.
For the full evaluation version (EPAR) of Competact, click here.
Last update of this summary: 06-2006.
Competact information published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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