LOWER DAILY DOSE WITH BETTER OUTCOMES WITH ORAL AGENTS AND AM INSULIN TOUJEO ADMINISTRATION THAN LANTUS WHILE ATTAINING DESIRABLE GLYCEMIC CONTROL IN TYPE 2 DIABETES

Nancy Hampton, Sarah Exley, Sandra Robbins and Udaya M. Kabadi*

ABSTRACT

Background: Lower daily dose with better outcomes with oral agents and AM insulin Toujeo administration than Lantus while attaining desirable glycemic control in type 2 Diabetes: Clinical trials (Edition) documented higher daily dose of Toujeo (Insulin Glargine U 300) to achieve non inferior glycemic control compared to Lantus (Insulin Glargine U100). In these trials, both insulins were administered in late evening (PM) or bedtime (HS). We recently documented several therapeutic advantages of Lantus administration in AM as compared to HS. Objective: Comparison between glycemic and other outcomes following therapy with AM administration of insulin Toujeo vs. Lantus in subjects with type 2 Diabetes with lapse of desirable glycemic control while receiving oral agents. Subjects and methods: 16 consecutive adult subjects, with history of type 2 diabetes were recruited because of rise in HbA1c over 8% while receiving oral agents. Subjects were randomized to 2 groups: adjunctive therapy with Insulin Toujeo or Lantus, initial dose, 0.2 units/ kg to be administered in AM at same time daily. Both insulins were titrated by 2 units, every 4 and 3 days for Toujeo and Lantus respectively until AM preinjection blood sugar, 80-130 mg/dl was attained. Daily dose was further adjusted to maintain AM blood sugar in the same range. Subjects were requested to determine blood sugars to confirm hypoglycemia (blood sugar <70 mg/dl) on occurrence of symptoms and institute treatment. Subject also continued same diet and activity profile and medications for other disorders throughout the study period of 6 months. Fasting plasma glucose (FPG), HbA1c and body weight (BW) were determined prior to and again at 3 and 6 months. Daily dose of insulin at 6 months and number of hypogly-cemic events (hypo g) during 6 months of treatment are reported. Statistical comparisons between groups are conducted by student's 't' test and analysis of variance. All data are reported as Mean ± SEM. Results: Mean ages and duration of diabetes were not significantly different between groups (Toujeo, 48 ± 4 and 13 ± 4 years; Lantus, 51 ± 4 and 11 ± 5 years). FPG and HbA1C declined to 80-130 mg/dl and < 7.5 % respectively. Daily insulin dose/ kg BW and number of hypoglycemic events were significantly lower in subjects administered insulin Toujeo as compared to subjects receiving Lantus. Moreover, daily dose of insulin Toujeo required to reduce HbA1c concentration by 1 point from initial level was also significantly lower when compared with insulin Lantus. Body weights were not significantly different at 6 months when compared to pretreatment with either insulin Toujeo or Lantus although the change in BW with Toujeo ( -1.0 ± 0.3 kg) was significantly different when compared with Lantus (3.2 ± 0.7 kg; p <0.05). No significant correlations were noted between daily insulin dose on one aspect and age, duration of diabetes, body weight and initial FPG or HbA1C on the other for either insulin. Conclusion: Desirable glycemic control can be attained by addition of either insulin Toujeo or Lantus to oral agents in subjects with type 2 Diabetes. However, when administered in AM, daily dose of insulin Toujeo may be lower with less hypoglycemic events and greater weight neutrality in comparison to insulin Lantus. Thus, insulin Toujeo may be more effective and safer than Lantus.

Keywords: Lower daily dose with Toujeo effective and safer than Lantus.