Late-breaking Abstracts
Topic
Basic and Clinical Science
Abstract title
Less daily dose and better outcomes with OAD and AM Toujeo than Lantus with similar glycemic control in type 2 Diabetes
Co-authors
U. Kabadi1, S. Exley2, N. Hampton2, S. Robbins2.
1Broadlawns Medical Center and University of Iowa, Endocrinology, Des Moines, USA.
2Broadlawns Medical Center, Endocrinology, Des Moines, USA.
Abstract body
Background
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.
Aim
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.
Method
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 hypoglycemic 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 from 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.
Discussion
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. Therefore, in final analysis, this preliminary pilot study shows that Insulin Toujeo may be as or more effective and safer than its administration in PM as well as insulin Lantus. A clinical trial in a large  population of subjects using a crossover design in a randomized sequence regarding the time of administration, AM vs PM  while using the same oral drugs in the same daily dose is likely to  eliminate impact of several factors including variability of individual insulin sensitivity and is therefore in order examine to the findings in this study.

Less daily dose and better outcomes with OAD and AM Glargine U300 than U100 with similar glycemic control in type 2 DM