Magazine article Drug Topics

New Combination Pill Approved for Type 2 Diabetes

Magazine article Drug Topics

New Combination Pill Approved for Type 2 Diabetes

Article excerpt

A new fixed-dose combination pill from Novo Nordisk and Sciele Pharma will now offer patients with diabetes mellitus another treatment option. The Food and Drug Administration (FDA) approved PrandiMet, the first and only fixed-dose combination that comprises a fast-acting secretagogue repaglinide (Prandin) and insulin sensitizer, metformin, for patients unable to achieve glycemic control using the single therapy of meglitinide or metformin.

According to Novo Nordisk and Sciele Pharma, PrandiMet works to optimize glycemic control by counteracting the three abnormalities of Type 2 diabetes: impaired insulin secretion, insulin resistance, and excessive hepatic glucose production.

"This new combination drug brings together two anti-diabetic agents with different mechanisms of action," Sum Lam, Pharm.D., CGP, BCPS, assistant clinical professor at St. John's University, said.

Repaglinide reduces postprandial glucose (PPG) by stimulating the release of insulin from the pancreas after a meal. Metformin decreases hepatic glucose production, increases peripheral glucose uptake, and improves insulin sensitivity. While compliance to medications is important, Lam believes that it is also necessary for patients to pay attention to diet and exercise regimen to optimize blood glucose control.

PrandiMet's approval was based on a clinical trial in which 83 patients with Type 2 diabetes with inadequate glycemic control on metformin were randomized to receive add-on repaglinide, repaglinide monotherapy, or continued treatment with metformin monotherapy. Patients receiving combination therapy of metformin and repaglinide had a statistically significant improvement in HbA1c and fasting plasma glucose compared with both monotherapy arms (p<0.05).

PrandiMet is administered twice daily with meals. The starting dose should be individualized, based on the patient's current regimen, effectiveness, and tolerability. For patients who have inadequate glycemic control with metformin monotherapy, the initial recommended dose of PrandiMet is 1 mg repaglinide/500 mg metformin and titrated to reduce the risk of hypoglycemia with repaglinide. To reduce gastrointestinal side effects associated with starting metformin therapy, the recommended initial dosage for patients inadequately controlled with repaglinide therapy and starting PrandiMet is 1mg replaglinide/500 mg metformin, or 2 mg repaglinide/500 mg metformin. …

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