Insulin Degludec Versus Insulin Glargine in Insulin-Naive Patients With Type 2 Diabetes
A 1-year, randomized, treat-to-target trial (BEGIN Once Long)
- Bernard Zinman, MD1,
- Athena Philis-Tsimikas, MD2,
- Bertrand Cariou, MD, PHD3,
- Yehuda Handelsman, MD4,
- Helena W. Rodbard, MD5,
- Thue Johansen, MD6,
- Lars Endahl, PHD6,
- Chantal Mathieu, MD7⇓ and
- On behalf of the NN1250-3579 (BEGIN Once Long) Trial Investigators*
- 1Samuel Lunenfeld Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
- 2Scripps Whittier Diabetes Institute, La Jolla, California
- 3Clinique d’Endocrinologie, l’Institut du Thorax, CHU Nantes, Nantes, France
- 4Metabolic Institute of America, Tarzana, California
- 5Endocrine and Metabolic Consultants, Rockville, Maryland
- 6Novo Nordisk A/S, Søborg, Denmark
- 7UZ Leuven, University of Leuven, Leuven, Belgium
- Corresponding author: Chantal Mathieu, .
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.
- Received June 21, 2012.
- Accepted August 28, 2012.
- © 2012 by the American Diabetes Association.
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