ABSTRACT
Objective: To compare the efficacy and metabolic effects of pioglitazone-metformin and basic insulin therapy on type 2 diabetes mellitus (T2DM) patients with overweight or obesity and poor blood glucose control. Methods: A total of 153 T2DM patients with overweight or obesity and poor blood glucose control were enrolled in this study. They received treatment with pioglitazone-metformin (pioglitazone-metformin group, n = 77) or insulin glargine (basal insulin group, n = 76) for 6 months in addition to their previous oral hypoglycemic drugs. At baseline, 3 months and 6 months after treatment, glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG), 2 h post-prandial blood glucose (2hBG), fasting insulin (FINS), 2 h post-prandial insulin (2hINS), fasting C peptide (FCp), 2 h post-prandial C peptide (2hCp), body mass index (BMI), total cholesterol (TC), triglyceride (TG), high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), and hepatic fatty degeneration (expressed as controlled attenuation parameter [CAP] value) were observed and recorded. Results: At baseline, there were no significant differences in gender, age, BMI, HbA1c, FBG, 2hBG, FINS, 2hINS, FCp, 2hCp, TC, TG, HDL-C, LDL-C, CAP value, underlying diseases, or concomitant medicine between the two groups (all P>0.05). At 3 and 6 months after treatment, the HbA1c, FBG and 2hBG levels were significantly decreased versus those at the baseline in the two groups (all P0.05). Compared with the basal insulin group, the FINS, BMI and CAP values were significantly decreased in the pioglitazone-metformin group 3 and 6 months after treatment (P<0.05, P<0.01). After 6 months of treatment, there were no significant changes of blood lipid levels in both groups. Conclusion: In T2DM patients with overweight or obesity and poor blood glucose control, adding pioglitazone-metformin and basal insulin to their previous oral hypoglycemic drugs has similar hypoglycemic effect. However, patients receiving pioglitazone-metformin have better metabolic benefts such as lower BMI, lower insulin and improved hepatic fatty degeneration.
ABSTRACT
Objective To observe the efficacy and safety of pigolitazone/metformin fixed-dose combination therapy replacing metformin alone or combined with other anti-diabetes drugs in type 2 diabetes with poor glycemic control.Methods 80 cases were recruited,with an average age of (54.79±13.99)years,diabetes history of (9.76±6.59) and baseline HbA1c (9.06±1.34)％.All participants received pigolitazone/metformin instead of metformin without other treatment changes.Glycemic control (level of fast blood glucose,HbA1c) was evaluated at 12 weeks,as well as lipid profiles,liver and renal function,adverse events and body weight.Results 8 cases were lost to visit,4 cases were withdrawn for edema,only 68 subjects finished the study.Compared to the baseline,after 12-week treatment,FPG decreased for (2.06+0.16) mmol/L,HbA1c decreased for (0.84+0.23)％,both of the differences were statistically significant (P＜0.001,P＜0.001).Body weight increased (0.34+1.13)kg,with no difference compared to the baseline.The lipid profile presented elevated high density lipoprotein cholesterol (P=0.012)and decreased total cholesterol,low density lipoprotein cholesterol,triglyceride,while the latter three items showed no differences (P＞0.05,P＞0.05,P＞0.05).Indexes reflecting liver and renal function,such as ALT,AST,TBIL,DBIL,Urea,UA,Cr showed no differences compared with the baseline.Adverse events analysis showed at the end of the study,no severe hypoglycemia and serious cardiovascular events occurred,6 cases suffered edema,among whom 4 patients exited the study for severe lower limb edema.No extra gastrointestinal symptom happened.Conclusion Pigolitazone/metformin fixed-dose combination exhibits an excellent efficacy and safety for T2DM,with satisfying tolerability and compliance,which is a selection for those patients with poor glycemic control.