title: Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Patients with Type 2 Diabetes (Begin: Compare).
abstract: 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 drugs.
  
  
  METHODS
  In this 22-week, treat-to-target trial, eligible adult patients with T2DM were randomized 1:1 to IDeg 200 or IDeg 100 U/mL once daily (OD) (n = 186 and 187, respectively). The starting insulin dose was based on a 1:1 transfer of the total prerandomization basal insulin dose. The primary endpoint was change (%) from baseline in glycosylated hemoglobin A1C (A1C) after 22 weeks of treatment.
  
  
  RESULTS
  A total of 373 subjects (mean age 59.8 years, A1C 8.2%, fasting plasma glucose 149.6 mg/dL [8.3 mmol/L], body mass index 33.3 kg/m2) were randomized. A1C reduction with IDeg 200 U/mL was noninferior to that of IDeg 100 U/mL (IDeg 200 U/mL - IDeg 100 U/mL estimated treatment difference: -0.11%, 95% confidence interval (CI): -0.28 to 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 and 100 U/mL, respectively). Similarly, the rates of nocturnal confirmed hypoglycemia were low (1.27 and 1.70 events/PYE for 200 and 100 U/mL). In general, both IDeg formulations were well tolerated (respective rates of adverse events: 4.16 and 3.00 events/PYE for 200 and 100 U/mL).
  
  
  CONCLUSIONS
  The 200 and 100 U/mL formulations of IDeg provide comparable and effective levels of glycemic control with similar, low rates of overall confirmed and nocturnal confirmed hypoglycemia.
authors: Atlanta Diabetes Associates, Atlanta, Georgia.
authors: Bruce W
authors: BW
authors: Bode
authors: Meridien Research, Bradenton, Florida.
authors: Louis B
authors: LB
authors: Chaykin
authors: Rainier Clinical Research Center, Renton, Washington.
authors: Allen M
authors: AM
authors: Sussman
authors: Physicians East, Greenville, North Carolina.
authors: Mark L
authors: ML
authors: Warren
authors: Novo Nordisk A/S, Søborg, Denmark.
authors: Marcus
authors: M
authors: Niemeyer
authors: Novo Nordisk A/S, Søborg, Denmark.
authors: Rasmus
authors: R
authors: Rabøl
authors: Endocrine and Metabolic Consultants, Rockville, Maryland.
authors: Helena W
authors: HW
authors: Rodbard
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D001835:Body Weight; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D049528:Insulin, Long-Acting / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D049528:Insulin, Long-Acting; C571886:insulin degludec