Home » Drug Information » FDA Approved Drugs » 2005
Medical Areas: Endocrinology | Family Medicine
View By:YearCompanyConditionsTherapeutic AreasDrug Names
ACTOplus met (pioglitazone hydrochloride and metformin hydrochloride)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved August of 2005
Treatment Area: type 2 diabetes
ACTOplus met is a single dose combination of two approved drugs for the treatment of type 2 diabetes: Actos (pioglitazone) and metformin. Actos reduces insulin resistance and metformin lowers the amount of blood sugar made by the liver.
ACTOplus met is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and metformin or who have inadequate glycemic control on a thiazolidinedione alone or metformin alone.
ACTOplus met is supplied as a tablet for oral administration. The recommended initial dose is as follows:
Starting dose for patients inadequately controlled on metformin monotherapy
Based on the usual starting dose of pioglitazone (15-30 mg daily), ACTOplus met may be initiated at either the 15 mg/500 mg or 15 mg/850 mg tablet strength once or twice daily, and gradually titrated after assessing adequacy of therapeutic response.
Starting dose for patients who initially responded to pioglitazone monotherapy and require additional glycemic control
Based on the usual starting doses of metformin (500 mg twice daily or 850 mg daily), ACTOplus met may be initiated at either the 15 mg/500 mg twice daily or 15 mg/850 mg tablet strength once daily, and gradually titrated after assessing adequacy of therapeutic response.
Starting dose for patients switching from combination therapy of pioglitazone plus metformin as separate tablets
ACTOplus met may be initiated with either the 15 mg/500 mg or 15 mg/850 mg tablet strengths based on the dose of pioglitazone and metformin already being taken.
At the time of FDA approval, no efficacy studies had been conducted with ActoPlus Met single tablets. However, efficacy and safety of the separate components had been previously established. In addition, the the co-administration of the separate components was evaluated for efficacy and safety in two clinical studies, demonstrating the bioequivalence with Actoplus Met.
This randomized, controlled study enrolled 328 subjects receiving metformin, either alone or in combination with another antihyperglycemic agent, who had inadequate glycemic control. The subjects received either 30 mg of pioglitazone or placebo once daily for 16 weeks in addition to their established metformin regimen. The addition of pioglitazone 30 mg once daily to metformin treatment significantly reduced the mean A1C by 0.83% and the mean fasting plasma glucose (FPG) by 37.7 mg/dL at Week 16 from that observed with metformin alone.
This randomized, controlled study enrolled 827 subjects receiving metformin, either alone or in combination with another antihyperglycemic agent, who had inadequate glycemic control. The subjects received either 30 mg or 45 mg of pioglitazone once daily for 24 weeks in addition to their established metformin regimen. The mean reductions from Baseline at Week 24 in A1C were 0.80% and 1.01% for the 30 mg and 45 mg doses, respectively. Mean reductions from Baseline in FPG were 38.2 mg/dL and 50.7 mg/dL, respectively.Based on these reductions in A1C and FPG, the addition of pioglitazone to metformin resulted in significant improvements in glycemic control irrespective of the metformin dose.
Adverse events associated with the use of ACTOplus met may include, but are not limited to, the following:
- Upper Respiratory Tract Infection
- Urinary Tract Infection
- Edema Lower Limb
- Weight Increased
Mechanism of Action
ACTOplus met combines two antihyperglycemic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes: pioglitazone hydrochloride, a member of the thiazolidinedione class, and metformin hydrochloride, a member of the biguanide class. Thiazolidinediones are insulin-sensitizing agents that act primarily by enhancing peripheral glucose utilization, whereas biguanides act primarily by decreasing endogenous hepatic glucose production.
For additional information regarding ACTOplus met or type 2 diabetes, please visit the Actos web page.