Endocrine Abstracts

Background: There aren’t published randomized studies comparing the clinical impact of degludec and Glragina U300 in the treatment of type 1 diabetes patients. (T1DP)

Objective: To compare efficacy and safety of the new long acting analogues Glargine U 300 and Degludec in 300 Type1 diabetes patients treated with basal/bolus treatment.(BBT)

Material and methods: Randomized control study 1.1 in 300 T1DP treated with BBT with glargineU100 or Detemir who change to GlargineU300 or Degludec at 1500 h during 24 weeks, with telematic visit (using Emminens platform) 6 weeks after the change of the treatment. The efficacy is mainly measured by change of HbA1c, secundary measures evaluated where variabilitu (SD,CV), BMI, insulin doses and quality of life (DQol). Safety measure being number of hypoglycemias (<54 mg/dl,<7 mg/dl and at night) and severe hypoglycemias during the whole 6 months period. We present the results of the first 150 recruited patients, age: 39.3±11.7 years, sex (male 54%/female 46%), duration of the diabetes 19,43±11 years, previously treated with Glargina U100 one or two doses (63%) or detemir two doses (37%)

Results: Globally there is a significative improvement at 24 weeks in HbA1c (7.8±0.9 vs 7.6±1; P 0.002) and also in porcentaje of hypoglycemias in glucometer download (13.6, 6±12% vs 10,4±7,7; P 0.005). We found no significant differences in all the studied variables except except for the lower insulin dose needed in the degludec group vs glargineU300 (IBasal 6 m: 27.4±14 vs 34±14,P=0.009; IBasal 6 m/kg: 0.36±0.16, vs 0.46±0.17,P=0.001 ; TDD(total daily dose)6 m/kg: 0.67±0.25 vs 0.79±0.27, P=0.011.

Conclusions: In T1DP the change of the treatment to the new long acting analogues degludec or Glargine U300 leads to an improvement in metabolic control in 24 weeks with less percentage of hypoglycemia and a a dose 22% inferior for degludec. We found no differences in metabolic (HbA1c, CV, BMI, Dqol) or safety variables(mild or severe hipoglucemias in 6 months) evaluadas. A larger number of patients and a longer period of follow up will help to corroborate those results.