PT  - JOURNAL ARTICLE
AU  - Zinman, Bernard
AU  - Philis-Tsimikas, Athena
AU  - Cariou, Bertrand
AU  - Handelsman, Yehuda
AU  - Rodbard, Helena W.
AU  - Johansen, Thue
AU  - Endahl, Lars
AU  - Mathieu, Chantal
AU  - , 
TI  - Insulin Degludec Versus Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes
AID  - 10.2337/dc12-1205
DP  - 2012 Oct 04
TA  - Diabetes Care
PG  - DC_121205
4099  - http://care.diabetesjournals.org/content/early/2012/10/02/dc12-1205.short
4100  - http://care.diabetesjournals.org/content/early/2012/10/02/dc12-1205.full
AB  - OBJECTIVE To compare ultra–long acting insulin degludec with glargine for efficacy and safety in insulin-naive patients with type 2 diabetes inadequately controlled with oral antidiabetic drugs (OADs).RESEARCH DESIGN AND METHODS In this 1-year, parallel-group, randomized, open-label, treat-to-target trial, adults with type 2 diabetes with A1C of 7−10% taking OADs were randomized 3:1 to receive once daily degludec or glargine, both with metformin. Insulin was titrated to achieve prebreakfast plasma glucose (PG) of 3.9−4.9 mmol/L. The primary end point was confirmation of noninferiority of degludec to glargine in A1C reduction after 52 weeks in an intent-to-treat analysis.RESULTS In all, 1,030 participants (mean age 59 years; baseline A1C 8.2%) were randomized (degludec 773, glargine 257). Reduction in A1C with degludec was similar (noninferior) to that with glargine (1.06 vs. 1.19%), with an estimated treatment difference of degludec to glargine of 0.09% (95% CI −0.04 to 0.22). Overall rates of confirmed hypoglycemia (PG <3.1 mmol/L or severe episodes requiring assistance) were similar, with degludec and glargine at 1.52 versus 1.85 episodes/patient-year of exposure (PYE). There were few episodes of nocturnal confirmed hypoglycemia in the overall population, and these occurred at a lower rate with degludec versus glargine (0.25 vs. 0.39 episodes/PYE; P = 0.038). Similar percentages of patients in both groups achieved A1C levels <7% without hypoglycemia. End-of-trial mean daily insulin doses were 0.59 and 0.60 units/kg for degludec and glargine, respectively. Adverse event rates were similar.CONCLUSION Insulins degludec and glargine administered once daily in combination with OADs provided similar long-term glycemic control in insulin-naive patients with type 2 diabetes, with lower rates of nocturnal hypoglycemia with degludec.