Control of Glycemia With a Basal-Plus Regimen in People With Type 2 Diabetes Mellitus Insufficiently Controlled by Previous Treatment

Background: Type 2 diabetes mellitus (T2DM) is often characterized by insulin resistance and progressive ?-cell deterioration. With longer duration of T2DM most patients treated with oral antihyperglycemic drugs (OADs), in monotherapy or in combination, will ultimately require basal insulin therapy and even further prandial intensification later on. The basal-plus regimen is one of the proposed approaches for treatment intensification by adding one injection of prandial rapid-acting insulin to basal insulin. The CONBA+ study aimed to collect real-world data of glycemic control of T2DM patients uncontrolled on insulin/OAD therapy using the basal-plus approach in Morocco. Methods: CONBA+ study was a national, prospective, non-interventional, multicenter study involving 50 endocrinologists from Morocco. The study, conducted between June 2015 and June 2017, enrolled T2DM patients uncontrolled on their previous regimen (hemoglobin A1c (HbA1c) ? 7.5% on two OADs, glargine 100 U/mL and OADs or once daily premixed insulin). Patients continued or newly initiated once-daily insulin glargine 100 U/mL (Gla-100) and also received one injection of insulin glulisine (Glu) at the main meal in replacing any previous treatment. Demographics, glycated hemoglobin (HbA1c), fasting blood glucose (FBG), postprandial glucose (PPG), insulin doses and the frequency of hypoglycemia were assessed at baseline and at 12 and 24 weeks after study entry. Results: Overall, 854 people (46.8% men) fulfilled the inclusion criteria. At baseline, mean age was 59.0 ± 9.4 years, mean duration of diabetes 10.8 ± 6.7 years (range: 1 - 45 years), mean body mass index (BMI) 27.4 ± 4.0 kg/m 2 and mean HbA1c 9.50±1.51%. After 24 weeks, 33.0% of patients achieved target HbA1c < 7.0% (primary endpoint). In addition, mean FPG and postprandial blood glucose (PPBG) improved significantly at week 24 (change from baseline: -88 mg/dL and -108 mg/dL respectively; P < 0.001) while the number of reported severe hypoglycemia was low. Conclusions: The use of a basal-plus regimen consisting of insulin glargine 100 U/mL and insulin glulisine injected at the main meal resulted in significant improvements of glycemic parameters. In addition, the basal-plus approach showed a good safety profile with a low risk of hypoglycemia. J Endocrinol Metab. 2020;10(1):16-22 doi: https://doi.org/10.14740/jem548