Efficacy and Safety of Insulin Degludec 200 U/ML and Insulin Degludec 100 U/ML in Patients with Type 2 Diabetes (Begin: Compare).
Endocr Pract. 2014 Feb 11;:1-16
Authors: Bode BW, Chaykin LB, Sussman AM, Warren ML, Niemeyer M, Rabøl R, Rodbard HW
Objective: The purpose of the present study was to provide clinical data on the efficacy and safety of insulin degludec (IDeg) 200 U/mL compared with IDeg 100 U/mL in patients with type 2 diabetes mellitus (T2DM) currently treated with basal insulin in combination with oral antidiabetic therapy.Methods: In this 22-week, treat-to-target trial, eligible adult patients with T2DM were randomized 1:1 to IDeg 200 U/mL once daily (n=186) or IDeg 100 U/mL once daily (n=187). The starting insulin dose was based on a 1:1 transfer of total pre-randomization basal insulin dose. The primary endpoint was change from baseline in hemoglobin A1C (A1C) (%) after 22 weeks of treatment.Results: A total of 373 subjects (mean age 59.8 years, A1C 8.2%, FPG 149.6 mg/dL (8.3 mmol/L), BMI 33.3 kg/m2) were randomized. A1C reduction with IDeg 200 U/mL was non-inferior to that of IDeg 100 U/mL (IDeg 200 U/mL-IDeg 100 U/mL estimated treatment difference: -0.11% [95% CI: -0.28; 0.05]). Rates of overall confirmed hypoglycemia were low and similar between both formulations (5.17 and 5.66 events/patient-year of exposure [PYE] for IDeg 200 U/mL and IDeg 100 U/mL). Similarly, rates of nocturnal confirmed hypoglycemia were low (1.27 and 1.70 events/PYE for 200 U/mL and 100 U/mL). In general, both IDeg formulations were well tolerated (rate of adverse events: 4.16 and 3.00 events/PYE for 200 U/mL and 100 U/mL).Conclusion: The 200 and 100 U/mL formulations of IDeg provide comparable, effective levels of glycemic control with similar, low rates of overall confirmed and nocturnal confirmed hypoglycemia.
PMID: 24518180 [PubMed - as supplied by publisher]