ABSTRACT
Context: Oral antidiabetic drug (OAD) failure is an indication for starting insulin therapy, but there is still a dilemma as to whether basal insulin or a premixed/co-formulation analog should be the choice. Aim: To compare the safety and efficacy of once daily (OD) insulin degludec/insulin aspart (IDegAsp) to OD insulin glargine (IGlar U100) in insulin-naïve Indian subjects with type 2 diabetes mellitus (T2DM), inadequately controlled with OADs alone. Setting and design: Retrospective study. Methods and material: Data was retrieved from the author’s clinic database of OAD failure patients (18-80 years), who were started either with (IGlar U100, n = 120) or IDegAsp (n = 89) OD over and above the standard of care. Data of fasting plasma glucose (FPG), postprandial plasma glucose (PPG) and glycated hemoglobin (HbA1c) from baseline and at last follow-up visits were collected. Statistical analysis used: Baseline characteristics and change in study parameters during the follow-up period were computed between two groups (IGlar U100 vs. IDegAsp) by unpaired t-test and paired t-test, respectively. ANCOVA test was used to compute percentage reduction in body weight, body mass index (BMI), FPG, PPG and HbA1c in between two groups (IGlar U100 vs. IDegAsp). Results: IDegAsp caused a significantly greater reduction in FPG, PPG and HbA1c as compared to the IGlar U100 arm. There was no significant difference in the proportion of patients with hypoglycemia between IDegAsp and IGlar U100 groups (p = 0.208). No episodes of severe hypoglycemia were reported. Conclusion: Comparison of IDegAsp and IGlar U100 OD in T2DM patients indicated that both were relatively safe but the former controlled FPG and PPG levels more effectively.
ABSTRACT
OBJECTIVE: To summarize the liver transporter-mediated drug interactions with oral antidiabetic agents.
ABSTRACT
OBJECTIVE: The use of oral hypoglycemic drugs in pregnant women has been limited and therefore there is scanty information on their safety. Concern about possible adverse effects of these drugs on the fetus led us to collect the cases of unintentional fetal exposure to oral antidiabetic agent during embryogenesis for comparision with an appropriately matched control group from the same clinic population. METHODS: Eight type 2 diabetic pregnant women with accidental exposure to oral antidiabetic agent during early pregnancy and 20 type 2 diabetic pregnant women matched for age, weight, and glycemic control but not exposed to oral antidiabetic agent were studied retrospectively. RESULTS: Three neonates (38%) in the exposed group had congenital malformations and still birth, compared with 5 (25%) in the control group (Odds ratio 1.8 (0.2-13.8), P>0.05). In the control group, the mean of HbA1c of 5 mothers of neonates with anomalies and stillbirth were higher than that of 15 mothers of neonates without anomaly (8.8% vs 6.2%, p=0.1) and the anomalies were major congenital malformation including three congenital heart diseases (1 ventricular septal defect, 2 patent ductus arteriosus) and one renal agenesis. In the exposed group, the mean of HbA1c of 3 mothers of neonates with anomalies and stillbirth were higher than that of 5 mothers of neonates without anomaly (9.0% vs 6.3%, p=0.4) and the anomlies were urachal sinus and facial palsy which was not commonly described in diabetic embryopathy. CONCLUSION: Although this study, due to the limited number of pregnancies examined, does not exclude an association between treatment with oral antidiabetic agent at the time of embryogenesis and congenital malformations in the offspring, the risk of our results is lower than that of others. The final answer will demand a much larger number of pregnancies studied prospectively.