What is Glustin?
Glustin is a medicine that contains the active substance pioglitazone. The white round tablets contain 15, 30 or 45 mg of pioglitazone.
What is Glustin used for?
Glustin is used to treat type 2 diabetes (also known as non-insulin-dependent diabetes). It can be used alone (monotherapy) in patients (especially if overweight) who cannot take metformin (an antidiabetic medicine). It can also be used together with another antidiabetic medicine (dual therapy). It can be added to metformin in patients (especially if overweight) who are not adequately controlled with metformin alone at the maximum tolerated dose; or it can be added to a sulphonylurea (another antidiabetic drug) in patients for whom metformin is contraindicated and who are not adequately controlled with the sulphonylurea alone at the maximum tolerated dose. It can be used together with two other antidiabetic medicines, metformin and sulphonylurea, as triple therapy in patients (especially if overweight) who are not adequately controlled with these two medicines.
It can be used together with insulin in patients who are not adequately controlled with insulin alone and who cannot take metformin.
How is Glustin used?
Glustin should be taken once a day, with or without food. The dose should be adjusted to get the best effect. The recommended starting dose is 15 mg or 30 mg once a day. It may be necessary to increase the dose after one or two weeks up to 45 mg once a day. In combination with metformin the current metformin dose can be continued even after starting treatment with Glustin. In combination with a sulphonylurea or with insulin, the current dose of sulphonylurea or insulin can be continued even after starting treatment with Glustin, provided the patient does not suffer from hypoglycemia (low blood glucose concentration), in which in case the dose of sulphonylurea or insulin needs to be reduced.
How does Glustin 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. Pioglitazone, the active ingredient in Glustin, makes cells more sensitive to insulin, so the body makes better use of the insulin it produces, the rate of glucose in the blood is reduced and this serves to control type 2 diabetes.
What studies have been carried out on Glustin?
Glustin has been studied in clinical pharmacology and clinical trials. In total, around 7, 000 patients received Glustin. Glustin was compared with placebo (a dummy treatment) or other antidiabetic medicines (metformin, gliclazide) during these studies. In some studies Glustin has also been tested in combination with other antidiabetic drugs (sulfonylureas, insulin or metformin). Other studies have examined the long-term use of Glustin. In triple therapy, the efficacy of Glustin was examined in over 1400 patients taking a combination of metformin and sulfonylurea with the addition of Glustin or placebo up to a maximum of 3.5 years.
These studies measured the concentration in the blood of a substance (glycosylated hemoglobin, HbA1c) which gives an indication of the efficacy of blood glucose control.
What benefit has Glustin shown during the studies?
Glustin induced a decrease in HbA1c, showing that blood glucose levels had decreased with dosages of 15, 30 and 45 mg. Dosages below 15 mg were not effective and dosages above 45 mg (once a day) did not show any additional benefit. Taken as a single agent, Glustin was as effective as metformin and gliclazide. Taken in combination with other drugs, Glustin has been shown to improve the control of type 2 diabetes when added to ongoing treatment. At the end of the triple therapy study, the addition of Glustin to the ongoing metformin and sulphonylurea treatment resulted in a 0.94% decrease in HbA1c levels, while the addition of placebo produced a 0.35% reduction . In a minor study to examine the combination of Glustin and insulin in 289 patients, patients for whom Glustin was added to insulin reported a 0.69% reduction in HbA1c levels after six months, compared with 0.14% of patients for whom placebo was added.
What is the risk associated with Glustin?
The most common side effects found with Glustin were visual disturbances, upper respiratory tract infections (colds), weight gain and hypoesthesia (decreased sensitivity to stimuli). For the list of all side effects reported with Glustin, see the Package Leaflet.
Glustin should not be used in patients who are hypersensitive (allergic) to pioglitazone or any of the other ingredients, and in patients with liver problems, heart failure or diabetic ketoacidosis (high levels of ketones [acids] in the blood).
Why has Glustin been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Glustin's benefits are greater than its risks for the treatment of type 2 diabetes and recommended that it be given marketing authorization. The Committee also decided that Glustin should be considered as an alternative to standard treatment (metformin) in patients for whom metformin is contraindicated as a single agent (ie when used alone).
More information on Glustin
On 11 October 2000, the European Commission granted a marketing authorization valid throughout the European Union for Glustin to Takeda Europe R & D Center Limited. The marketing authorization was renewed on 13 October 2005.
For the full version of the EPAR click here.
Last update of this summary: 08-2007
