18 Sep 2007 06:00 PM
New Data For Galvus® Provide Further Evidence Of Robust Efficacy And Tolerability In Treating Patients With Type 2 Diabetes
Uncontrolled patients with type 2 diabetes treated with metformin, one of the most prescribed oral medicines for this disease, were four times more likely to achieve recommended blood sugar control levels by adding Galvus (vildagliptin) to their treatment compared to those who added a placebo, according to new clinical data1.
The study of 544 patients with type 2 diabetes who were inadequately controlled on metformin showed that 35.5% achieved glycemic control (HbA1c < 7.0%) when Galvus was added to the treatment regimen with metformin compared to 9.4% of those receiving metformin along with placebo (or sugar pill)1.
The results further showed that 54.1% of patients in a subset group with a baseline HbA1c of less than 8.0% achieved glycemic control after taking both Galvus and metformin compared to 13.3% among those who received metformin and a placebo1.
HbA1c is a test done to measure the average amount of sugar in the blood over the last two to three months. The American Diabetes Association recommends an HbA1c level of less than 7.0% to minimize the risk of severe complications, which can include heart disease, blindness, amputations, nerve damage and kidney failure2.
These findings, presented at the 43rd European Association for the Study of Diabetes (EASD), add to the growing evidence of data demonstrating the efficacy and tolerability of Galvus in treating a wide range of patients with type 2 diabetes, a progressive disease estimated to affect more than 28 million people in the European Union3.
Galvus is a member of a new class of medicines called DPP-4 inhibitors. European Union approval is expected soon after the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines scientifically in Europe, issued a positive opinion in July 2007. Galvus is expected to be approved as an add-on therapy to the most common oral anti-diabetes medicines - metformin, thiazolidinediones, and sulfonylureas.
"Clinical trials have consistently demonstrated the robust efficacy and good tolerability of Galvus in combination with many oral diabetes therapies," said James Shannon, MD, Global Head of Development at Novartis Pharma AG.
"Galvus has further proven its benefits in a wide range of patients, helping to bring blood sugar levels under control without the side effects, including weight gain and hypoglycemia, associated with other type 2 diabetes medicines such as sulfonylureas or thiazolidinediones," Dr. Shannon said.
Other data presented at the meeting confirmed that Galvus is well tolerated in patients with mild renal impairment4, a condition seen in about one-third of all type 2 diabetes patients5. Galvus also delivers strong efficacy and tolerability in the elderly6, the fastest growing group of type 2 diabetes patients7.
Separately, a new analysis of pooled data from 1,864 patients showed the safety and tolerability of Galvus in patients with predominantly mild renal (kidney) impairment was similar to both placebo as well as to patients who did not have renal impairment4. Type 2 diabetes is seen in some countries as the most frequent condition in people with renal impairment5. Almost half of all patients treated with Galvus during the clinical trial program had renal impairment.
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The study of 544 patients with type 2 diabetes who were inadequately controlled on metformin showed that 35.5% achieved glycemic control (HbA1c < 7.0%) when Galvus was added to the treatment regimen with metformin compared to 9.4% of those receiving metformin along with placebo (or sugar pill)1.
The results further showed that 54.1% of patients in a subset group with a baseline HbA1c of less than 8.0% achieved glycemic control after taking both Galvus and metformin compared to 13.3% among those who received metformin and a placebo1.
HbA1c is a test done to measure the average amount of sugar in the blood over the last two to three months. The American Diabetes Association recommends an HbA1c level of less than 7.0% to minimize the risk of severe complications, which can include heart disease, blindness, amputations, nerve damage and kidney failure2.
These findings, presented at the 43rd European Association for the Study of Diabetes (EASD), add to the growing evidence of data demonstrating the efficacy and tolerability of Galvus in treating a wide range of patients with type 2 diabetes, a progressive disease estimated to affect more than 28 million people in the European Union3.
Galvus is a member of a new class of medicines called DPP-4 inhibitors. European Union approval is expected soon after the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines scientifically in Europe, issued a positive opinion in July 2007. Galvus is expected to be approved as an add-on therapy to the most common oral anti-diabetes medicines - metformin, thiazolidinediones, and sulfonylureas.
"Clinical trials have consistently demonstrated the robust efficacy and good tolerability of Galvus in combination with many oral diabetes therapies," said James Shannon, MD, Global Head of Development at Novartis Pharma AG.
"Galvus has further proven its benefits in a wide range of patients, helping to bring blood sugar levels under control without the side effects, including weight gain and hypoglycemia, associated with other type 2 diabetes medicines such as sulfonylureas or thiazolidinediones," Dr. Shannon said.
Other data presented at the meeting confirmed that Galvus is well tolerated in patients with mild renal impairment4, a condition seen in about one-third of all type 2 diabetes patients5. Galvus also delivers strong efficacy and tolerability in the elderly6, the fastest growing group of type 2 diabetes patients7.
Separately, a new analysis of pooled data from 1,864 patients showed the safety and tolerability of Galvus in patients with predominantly mild renal (kidney) impairment was similar to both placebo as well as to patients who did not have renal impairment4. Type 2 diabetes is seen in some countries as the most frequent condition in people with renal impairment5. Almost half of all patients treated with Galvus during the clinical trial program had renal impairment.
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