written by Michael O’Leary
Another first-in-class drug is wending its way through the clinical trials process aimed at winning FDA approval for the treatment of type 2 diabetes. In early studies the drug, TAK-875, has been shown to lower HbA1c at rates similar to glimepiride (Amaryl).
TAK-875 is the first drug to reach clinical development that is aimed at blocking the GPR40 protein as a way to reduce insulin production.
(Link to published site)
The drug, developed by Takeda Global Research and Development blocks G-protein-coupled receptor 40 (GPR40), which is another protein involved in the regulation of blood sugar levels. In this case, GPR40 is produced by pancreatic islet cells and is activated by fatty acids in the blood. When one eats both fat and sugar, the GPR40 receptor stimulates greater insulin production, which hastens the onset of diabetes. Many researchers think this may be the key protein that explains why obesity is linked to development of type 2 diabetes.
Results of a phase II clinical trial were presented last July at the American Diabetes Association meeting in San Diego. In a phase II clinical trial researchers are often trying to determine the optimum dose that provides the greatest benefits with the least side effects. In the presentation reported on at the conference by Medpage Today, a total of 426 patients were randomly assigned to groups given either TAK-875, glimepiride (Amaryl) or placebo. Those in the TAK-875 group were given five different doses of TAK-875.
What they found at the end of 12 weeks of taking the drugs or a placebo was that not surprisingly, patients on all doses of TAK-875 lowered their HbA1c more than patients given a placebo. Those give a 50 micrograms (mcg) dose of TAK-875, however, achieved declines in A1c that were comparable to those taking glimepiride.
On the side effect side of the equation, significantly fewer people (2.3 percent) of those taking TAK-875 experienced too low blood sugar, or hypoglycemia, compared to 3.3 percent those in the glimepiride group.
In August, Takeda Global Research & Development, which funded the dosing trial, began enrolling participants in another phase II trial (NCT01414920) that will determine the effectiveness and safety of taking TAK-875 once daily in combination with sitagliptin (Januvia).
Another first-in-class drug is wending its way through the clinical trials process aimed at winning FDA approval for the treatment of type 2 diabetes. In early studies the drug, TAK-875, has been shown to lower HbA1c at rates similar to glimepiride (Amaryl).TAK-875 is the first drug to reach clinical development that is aimed at blocking the GPR40 protein as a way to reduce insulin production.
(Link to published site)
The drug, developed by Takeda Global Research and Development blocks G-protein-coupled receptor 40 (GPR40), which is another protein involved in the regulation of blood sugar levels. In this case, GPR40 is produced by pancreatic islet cells and is activated by fatty acids in the blood. When one eats both fat and sugar, the GPR40 receptor stimulates greater insulin production, which hastens the onset of diabetes. Many researchers think this may be the key protein that explains why obesity is linked to development of type 2 diabetes.
Results of a phase II clinical trial were presented last July at the American Diabetes Association meeting in San Diego. In a phase II clinical trial researchers are often trying to determine the optimum dose that provides the greatest benefits with the least side effects. In the presentation reported on at the conference by Medpage Today, a total of 426 patients were randomly assigned to groups given either TAK-875, glimepiride (Amaryl) or placebo. Those in the TAK-875 group were given five different doses of TAK-875.
What they found at the end of 12 weeks of taking the drugs or a placebo was that not surprisingly, patients on all doses of TAK-875 lowered their HbA1c more than patients given a placebo. Those give a 50 micrograms (mcg) dose of TAK-875, however, achieved declines in A1c that were comparable to those taking glimepiride.
On the side effect side of the equation, significantly fewer people (2.3 percent) of those taking TAK-875 experienced too low blood sugar, or hypoglycemia, compared to 3.3 percent those in the glimepiride group.
In August, Takeda Global Research & Development, which funded the dosing trial, began enrolling participants in another phase II trial (NCT01414920) that will determine the effectiveness and safety of taking TAK-875 once daily in combination with sitagliptin (Januvia).
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