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 diabetes medicine (dual therapy). It can be added to metformin in patients (especially if overweight) who are not adequately controlled on 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 on 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 on insulin alone and who cannot take metformin.
How is Glustin used?
Glustin is taken once a day, with or without meals. The dose should be adjusted for best effect. The recommended starting dose is 15 mg or 30 mg once daily. The dose may need to be increased after one or two weeks to 45 mg once daily. In combination with metformin the current dose of metformin can be continued even after initiation of Glustin treatment. In combination with a sulphonylurea or insulin, the current dose of sulphonylurea or insulin can be continued even after the initiation of Glustin treatment, provided that the patient does not suffer from hypoglycaemia (low blood glucose), in which the dose of sulphonylurea or insulin must be reduced.
How does Glustin 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. Pioglitazone, the active ingredient in Glustin, makes cells more sensitive to insulin, so the body uses the insulin it produces better, the blood glucose is reduced and this serves to control type 2 diabetes.
How has Glustin been studied?
Glustin has been studied in clinical pharmacology studies and in clinical trials. In total, approximately 7,000 patients received Glustin. In these studies Glustin was compared with placebo (a dummy treatment) or with other antidiabetic medicines (metformin, gliclazide). Glustin was also looked at in combination with other antidiabetic medicines (sulphonylureas, insulin or metformin) in some studies. Other studies have looked at the long-term use of Glustin. In triple therapy, the efficacy of Glustin was examined in over 1,400 patients taking a combination of metformin and sulphonylurea 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 effectiveness of blood glucose control."
What benefit has Glustin shown during the studies?
Glustin induced a drop in HbA1c, showing that blood glucose had decreased with dosages of 15, 30 and 45 mg. Dosages below 15 mg have not been shown to be effective and dosages above 45 mg (once daily) have shown no additional benefit. Taken on its own, Glustin was as effective as metformin and gliclazide. Taken in combination with other medications, 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, adding Glustin to ongoing metformin and sulphonylurea treatment resulted in a 0.94% decrease in HbA1c levels, while the addition of placebo resulted in a 0.35% decrease. . In a minor study examining 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% for patients for whom placebo was added.
What is the risk associated with Glustin?
The most common side effects seen with Glustin were vision disturbances, upper respiratory tract infections (colds), weight gain and hypoesthesia (decreased sensitivity to stimuli). For a list of all side effects reported with Glustin, see the Package Leaflet.
Glustin must 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 a marketing authorization for the medicine. The Committee also decided that as monotherapy (ie when used alone) Glustin should be considered an "alternative to standard treatment (metformin) in patients for whom metformin is contraindicated."
More information about Glustin
On 11 October 2000, the European Commission granted Takeda Europe R & D Center Limited a "Marketing Authorization" for Glustin, valid throughout the European Union. 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
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