Abstract
Background:
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 Competact™ (Takeda Pharma, Aachen, Germany) (marketed as ActoplusMet® in the United States)—a fixed combination of 850 mg of metformin with 15 mg of pioglitazone—for 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 ± SD age was 60.8 ± 9.6 years (2,171 women, 2,691 men; disease duration, 6.7 ± 4.7 years; body mass index [BMI], 31.0 ± 5.2 kg/m2). 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, non–HDL-cholesterol, and triglycerides) were collected at baseline and after 4 months.
Results:
All investigated parameters improved significantly (all P < 0.001) after 4 months of therapy with Competact (baseline vs. end point: systolic BP, 139.7 ± 15.1 vs. 134.4 ± 12.0 mm Hg; diastolic BP, 83.1 ± 8.9 vs. 80.5 ± 7.5 mm Hg; HbA1c, 7.8 ± 1.0% vs. 7.0 ± 0.8%; FBG, 9.0 ± 2.6 vs. 7.0 ± 1.7 mM; cholesterol, 5.7 ± 1.1 mM vs. 5.3 ± 0.9 mM; HDL-cholesterol, 1.2 ± 0.4 mM vs. 1.3 ± 0.4 mM; non–HDL-cholesterol, 4.5 ± 1.2 mM vs. 4.0 ± 0.9 mM; triglycerides, 2.5 ± 1.0 mM vs. 2.1 ± 0.8 mM; hsCRP, 3.2 ± 2.6 mg/L vs. 2.7 ± 2.3 mg/L). It is noteworthy that the BMI was not affected by Competact (31.0 ± 5.2 kg/m2 vs. 31.1 ± 6.1 kg/m2, P = 0.221).
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.