What is Competact?
Competact is presented as white oblong 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 (particularly 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 who switch from metformin to Competact alone may need to introduce pioglitazone slowly until they reach a dose of 30 mg a day. When necessary, it is possible to switch directly from metformin to Competact. Taking Competact during or immediately after meals may reduce stomach problems caused by metformin. In older patients, renal function should be monitored regularly.
How does Competact work?
Type 2 diabetes is a disease due to the fact that the pancreas does not produce enough insulin to control the level of glucose in the blood. Competact contains two active ingredients that each perform a different action. Pioglitazone makes cells (in adipose tissue, muscles and liver) more sensitive to insulin, so that the body makes better use of the insulin it produces. Metformin basically inhibits glucose production and reduces its absorption in the intestine. The result of the combined action of the two active ingredients is a reduction in blood glucose, which helps to control type 2 diabetes.
What studies have been carried out on Competact?
Pioglitazone alone has been approved by the European Union under the name 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 conducted on Actos used in combination with metformin but in 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) that gives an indication of the efficacy of blood glucose control.
What benefit has Competact shown during the studies?
In all the studies, the addition of 30 mg of pioglitazone to metformin enabled improved blood sugar control, with HbA1c levels further decreasing from 0.64 to 0.89% compared to levels obtained with only on metformin.
What are the risks associated with Competact?
The most common side effects of Competact (encountered between 1 and 10 patients in 100) are anemia (low red blood cell count), visual impairment, weight gain, arthralgia (joint pain), headache, hematuria (blood in the urine ), erectile dysfunction (problems getting an erection). For the full list of all side effects reported with Competact, see the Package Leaflet. Competact should not be used in patients allergic to pioglitazone, metformin or other components of the medicine, or patients with heart failure or liver or kidney problems. Competact should not be used in patients with a disease that causes lack of oxygen in the tissues such as a recent cardiac attack or shock. Competact should not be used in cases of alcohol poisoning, diabetic ketoacidosis (high ketone levels), conditions that may have effects on the kidneys and during breastfeeding. For the complete list of limitations, 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 active ingredients is needed . Decided that the benefits of Competact are greater than the risks for the treatment of type 2 diabetes. The CHMP therefore recommended that it be given marketing authorization for Competact.
More information on Competact:
On 28 July 2006, the European Commission granted a marketing authorization for Competact, valid throughout the European Union, to Takeda Global Research and Development Center (Europe) Ltd.
For the full version of the Competact assessment (EPAR), click here.
Last update of this summary: 06-2006.
