What is Glubrava?
Glubrava is a medicine available as white and oblong tablets containing two active substances, pioglitazone (15 mg) and metformin hydrochloride (850 mg).
The medicine is similar to Competact, which is already authorized in the European Union (EU). The company that makes Competact has agreed that its scientific data will be used for Glubrava.
What is Glubrava used for?
Glubrava is used in patients (particularly those who are overweight) with non-insulin-dependent diabetes (type 2 diabetes). Glubrava 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 Glubrava used?
The normal dose of Glubrava consists of one tablet taken twice a day. Patients switching from metformin alone to Glubrava may need to introduce pioglitazone slowly until they reach a dose of 30 mg a day. When necessary, it is possible to pass directly from metformin to Glubrava. Taking Glubrava during or immediately after meals may reduce stomach problems caused by metformin. In older patients, renal function should be monitored regularly.
How does Glubrava 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. Glubrava contains two active ingredients that each perform a different action. Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which allows the body to better use 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 Glubrava?
Pioglitazone alone has been approved by the EU as Actos and can be used together with metformin to treat type 2 diabetes in patients whose metformin alone does not allow sufficient control to be exercised. Three studies conducted on Actos used in combination with metformin as separate tablets were used to support the use of Glubrava for the same indication. 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 Glubrava shown during the studies?
In all the studies, the addition of 30 mg of pioglitazone to metformin allowed improved glucose control in the blood, with HbA1c levels falling further by 0.64 - 0.89% compared to the levels obtained with only metformin.
What is the risk associated with Glubrava?
The most common side effects of Glubrava (seen 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 ) and erectile dysfunctions (difficulty in erection). For the full list of all side effects reported with Glubrava, see the Package Leaflet.
Glubrava 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. Glubrava should not be used in patients with a disease that causes lack of oxygen in tissues such as a recent heart attack or shock. Glubrava should not be used in cases of alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may have effects on the kidneys and during breastfeeding. For the full list of limitations, see the package leaflet.
Why has Glubrava been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the efficacy of pioglitazone and metformin in type 2 diabetes has been demonstrated and that Glubrava simplifies treatment and improves compliance when a combination of active ingredients is needed .
The CHMP decided that Glubrava's benefits are greater than its risks for the treatment of type 2 diabetes and allowed the marketing authorization granted for Glubrava.
More information on Glubrava
On 11 December 2007, the European Commission granted a marketing authorization valid throughout the European Union for Glubrava to the Takeda Global Research and Development Center (Europe) Ltd.
The full EPAR for Glubrava can be found here.
Last update of this summary: 03-2008.
