Efficacy and Safety of Insulin Degludec and Insulin Glargine U-100 in Hospitalized Patients with Type 2 Diabetes—An Open-Label, Randomized Controlled Study

Abstract

Aims/Introduction: The short-term efficacy and safety of insulin degludec (IDeg) in patients with type 2 diabetes have not previously been reported. We evaluated target glycemic control and glucose variability in hospitalized patients with type 2 diabetes. Material and Methods: In an open-label, multicenter, randomized controlled trial, 74 patients were randomly assigned to an insulin glargine U100 (IGla) group (38 patients) or insulin degludec group (36 patients) and were administered Basal-bolus therapy during hospitalization. Continuous glucose monitoring was performed on Day 11 after the insulin treatment commenced, to verify that day’s glucose variability. Results: The proportion of patients achieving a fasting blood glucose level of 110 mg/dl and 2-hour postprandial blood glucose level of 180 mg/dl throughout at least a day during the observation period was 30.6% [95% confidence interval 18.2-45.5%, one-sided p-value = 0.057] (11/36) in the IGla group, and 31.3% [95% confidence interval 18.0-47.2%, one sided p-value = 0.056] (10/32) in the IDeg group. Although no significant difference was noted on the 6-point SMBG profiles in mean blood glucose levels between the groups, the IDeg group showed a significant improvement in the percentage change from baseline of mean blood glucose before lunch on Day 7 (p = 0.021) and after dinner on Day 12 (Day 7 before lunch: IGla group -29.5 ± 26.3%, IDeg group -44.5 ± 22.1%, p = 0.021; Day 12 after dinner: IGla group -34.2 ± 22.5%, IDeg group -51.1 ± 21.7%, p = 0.021). No significant differences were noted between the groups in the incidence of hypoglycemia or the glucose variability parameter data on continuous glucose monitoring. Conclusion: This study suggests that IDeg is comparable with IGla in short-term efficacy and safety for patients with type 2 diabetes in the initial phase of basal-bolus therapy. Disclosure J. Suzuki: None. T. Yamakawa: None. M. Shinoda: None. R. Sakamoto: None. K. Takahashi: None. Y. Terauchi: Research Support; Self; MSD K.K.. Speaker's Bureau; Self; MSD K.K.. Advisory Panel; Self; MSD K.K.. Research Support; Self; Ono Pharmaceutical Co., Ltd.. Speaker's Bureau; Self; Ono Pharmaceutical Co., Ltd.. Research Support; Self; Novartis Pharma K.K., Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Boehringer Ingelheim GmbH. Research Support; Self; Mitsubishi Tanabe Pharma Corporation. Speaker's Bureau; Self; Mitsubishi Tanabe Pharma Corporation. Advisory Panel; Self; Mitsubishi Tanabe Pharma Corporation. Research Support; Self; Daiichi Sankyo Company, Limited. Speaker's Bureau; Self; Daiichi Sankyo Company, Limited. Advisory Panel; Self; Daiichi Sankyo Company, Limited. Research Support; Self; Sanwa Kagaku Kenkyusho Co., Ltd.. Speaker's Bureau; Self; Sanwa Kagaku Kenkyusho Co., Ltd.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Advisory Panel; Self; Sanofi. Research Support; Self; Sumitomo Dainippon Pharma Co., Ltd.. Speaker's Bureau; Self; Sumitomo Dainippon Pharma Co., Ltd.. Research Support; Self; Shionogi & Co., Ltd.. Speaker's Bureau; Self; Shionogi & Co., Ltd., Bayer Yakuhin, Ltd., Astellas Pharma US, Inc., AstraZeneca. Advisory Panel; Self; AstraZeneca, Teijin Pharma Limited.