Competact, a Fixed Combination of Pioglitazone and Metformin, Improves Metabolic Markers in Type 2 Diabetes Patients with Insufficient Glycemic Control by Metformin AloneâResults from a Post-Marketing Surveillance Trial Under Daily Routine Conditions
AbstractBackground: In patients with type 2 diabetes, glycemic control to target goals can only be achieved for a while by single-drug treatment. Antidiabetes therapy has to be adapted according to the individual course of the disease. This trial investigates the impact of Competactâ¢ (Takeda Pharma, Aachen, Germany) (marketed as ActoplusMet Â® in the United States)âa fixed combination of 850âmg of metformin with 15âmg of pioglitazoneâfor diabetes treatment in patients with insufficient glycemic control by metformin alone. Study Design: This observational drug monitoring trial was performed at 1,480 study sites in Germany, and 4,866 complete patient data sets were included into the final analyses. Mean Â± SD age was 60.8âÂ±â9.6 years (2,171 women, 2,691 men; disease duration, 6.7âÂ±â4.7 years; body mass index BMI, 31.0âÂ±â5.2âkg/m 2 ). In total, 43.8% of the patients received lipid-lowering drugs (antihypertensive medication, 74.3%). Main inclusion criteria were type 2 diabetes, metformin monotherapy, and an initial hemoglobin A1c (HbA1c) value between 6.6% and 9.9%. Parameters of glycemic control (HbA1c, fasting blood glucose FBG), blood pressure (BP), inflammation (high-sensitivity C-reactive protein hsCRP), and lipid metabolism (total cholesterol, high-density lipoprotein HDL-cholesterol, nonâHDL-cholesterol, and triglycerides) were collected at baseline and after 4 months. Results: All investigated parameters improved significantly (all Pâ <â0.001) after 4 months of therapy with Competact (baseline vs. end point: systolic BP, 139.7âÂ±â15.1 vs. 134.4âÂ±â12.0âmm Hg; diastolic BP, 83.1âÂ±â8.9 vs. 80.5âÂ±â7.5âmm Hg; HbA1c, 7.8âÂ±â1.0% vs. 7.0âÂ±â0.8%; FBG, 9.0âÂ±â2.6 vs. 7.0âÂ±â1.7âm M ; cholesterol, 5.7âÂ±â1.1âm M vs. 5.3âÂ±â0.9âm M ; HDL-cholesterol, 1.2âÂ±â0.4âm M vs. 1.3âÂ±â0.4âm M ; nonâHDL-cholesterol, 4.5âÂ±â1.2âm M vs. 4.0âÂ±â0.9âm M ; triglycerides, 2.5âÂ±â1.0âm M vs. 2.1âÂ±â0.8âm M ; hsCRP, 3.2âÂ±â2.6âmg/L vs. 2.7âÂ±â2.3âmg/L). It is noteworthy that the BMI was not affected by Competact (31.0âÂ±â5.2âkg/m 2 vs. 31.1âÂ±â6.1âkg/m 2 , Pâ â=â0.221). Conclusions: These observational results, obtained from a non-selected patient population under daily routine conditions, show the beneficial effects of a pioglitazone/metformin combination for diabetes patients with insufficient glycemic control under daily routine conditions.