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PMID- 28672317
OWN - NLM
STAT- In-Process
DA  - 20170703
LR  - 20170703
IS  - 1538-3598 (Electronic)
IS  - 0098-7484 (Linking)
VI  - 318
IP  - 1
DP  - 2017 Jul 04
TI  - Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients
      With Type 2 Diabetes: The SWITCH 2 Randomized Clinical Trial.
PG  - 45-56
LID - 10.1001/jama.2017.7117 [doi]
AB  - Importance: Hypoglycemia, a serious risk for insulin-treated patients with type 2
      diabetes, negatively affects glycemic control. Objective: To test whether
      treatment with basal insulin degludec is associated with a lower rate of
      hypoglycemia compared with insulin glargine U100 in patients with type 2
      diabetes. Design, Setting, and Participants: Randomized, double-blind,
      treat-to-target crossover trial including two 32-week treatment periods, each
      with a 16-week titration period and a 16-week maintenance period. The trial was
      conducted at 152 US centers between January 2014 and December 2015 in 721 adults 
      with type 2 diabetes and at least 1 hypoglycemia risk factor who were previously 
      treated with basal insulin with or without oral antidiabetic drugs.
      Interventions: Patients were randomized 1:1 to receive once-daily insulin
      degludec followed by insulin glargine U100 (n = 361) or to receive insulin
      glargine U100 followed by insulin degludec (n = 360) and randomized 1:1 to
      morning or evening dosing within each treatment sequence. Main Outcomes and
      Measures: The primary end point was the rate of overall symptomatic hypoglycemic 
      episodes (severe or blood glucose confirmed [<56 mg/dL]) during the maintenance
      period. Secondary end points were the rate of nocturnal symptomatic hypoglycemic 
      episodes (severe or blood glucose confirmed, occurring between 12:01 am and 5:59 
      am) and the proportion of patients with severe hypoglycemia during the
      maintenance period. Results: Of the 721 patients randomized (mean [SD] age, 61.4 
      [10.5] years; 53.1% male), 580 (80.4%) completed the trial. During the
      maintenance period, the rates of overall symptomatic hypoglycemia for insulin
      degludec vs insulin glargine U100 were 185.6 vs 265.4 episodes per 100
      patient-years of exposure (PYE) (rate ratio = 0.70 [95% CI, 0.61-0.80]; P < .001;
      difference, -23.66 episodes/100 PYE [95% CI, -33.98 to -13.33]), and the
      proportions of patients with hypoglycemic episodes were 22.5% vs 31.6%
      (difference, -9.1% [95% CI, -13.1% to -5.0%]). The rates of nocturnal symptomatic
      hypoglycemia with insulin degludec vs insulin glargine U100 were 55.2 vs 93.6
      episodes/100 PYE (rate ratio = 0.58 [95% CI, 0.46-0.74]; P < .001; difference,
      -7.41 episodes/100 PYE [95% CI, -11.98 to -2.85]), and the proportions of
      patients with hypoglycemic episodes were 9.7% vs 14.7% (difference, -5.1% [95%
      CI, -8.1% to -2.0%]). The proportions of patients experiencing severe
      hypoglycemia during the maintenance period were 1.6% (95% CI, 0.6%-2.7%) for
      insulin degludec vs 2.4% (95% CI, 1.1%-3.7%) for insulin glargine U100 (McNemar P
      = .35; risk difference, -0.8% [95% CI, -2.2% to 0.5%]). Statistically significant
      reductions in overall and nocturnal symptomatic hypoglycemia for insulin degludec
      vs insulin glargine U100 were also seen for the full treatment period.
      Conclusions and Relevance: Among patients with type 2 diabetes treated with
      insulin and with at least 1 hypoglycemia risk factor, 32 weeks' treatment with
      insulin degludec vs insulin glargine U100 resulted in a reduced rate of overall
      symptomatic hypoglycemia. Trial Registration: clinicaltrials.gov Identifier:
      NCT02030600.
FAU - Wysham, Carol
AU  - Wysham C
AD  - Rockwood Clinic, University of Washington School of Medicine, Spokane.
FAU - Bhargava, Anuj
AU  - Bhargava A
AD  - Iowa Diabetes and Endocrinology Research Center, Des Moines.
FAU - Chaykin, Louis
AU  - Chaykin L
AD  - Meridien Research, Bradenton, Florida.
FAU - de la Rosa, Raymond
AU  - de la Rosa R
AD  - Paducah Endocrinology, Paducah, Kentucky.
FAU - Handelsman, Yehuda
AU  - Handelsman Y
AD  - Metabolic Institute of America, Tarzana, California.
FAU - Troelsen, Lone N
AU  - Troelsen LN
AD  - Medical and Science, Novo Nordisk, Soborg, Denmark.
FAU - Kvist, Kajsa
AU  - Kvist K
AD  - Biostatistics Insulin and Diabetes Outcomes, Novo Nordisk, Soborg, Denmark.
FAU - Norwood, Paul
AU  - Norwood P
AD  - Valley Research, Fresno, California.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
EDAT- 2017/07/04 06:00
MHDA- 2017/07/04 06:00
CRDT- 2017/07/04 06:00
AID - 2635630 [pii]
AID - 10.1001/jama.2017.7117 [doi]
PST - ppublish
SO  - JAMA. 2017 Jul 4;318(1):45-56. doi: 10.1001/jama.2017.7117.