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PMID- 28672316
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 1 Diabetes: The SWITCH 1 Randomized Clinical Trial.
PG  - 33-44
LID - 10.1001/jama.2017.7115 [doi]
AB  - Importance: Hypoglycemia, common in patients with type 1 diabetes, is a major
      barrier to achieving good glycemic control. Severe hypoglycemia can lead to coma 
      or death. Objective: To determine whether insulin degludec is noninferior or
      superior to insulin glargine U100 in reducing the rate of symptomatic
      hypoglycemic episodes. Design, Setting, and Participants: Double-blind,
      randomized, crossover noninferiority trial involving 501 adults with at least 1
      hypoglycemia risk factor treated at 84 US and 6 Polish centers (January
      2014-January 12, 2016) for two 32-week treatment periods, each with a 16-week
      titration and a 16-week maintenance period. Interventions: Patients were
      randomized 1:1 to receive once-daily insulin degludec followed by insulin
      glargine U100 (n = 249) or to receive insulin glargine U100 followed by insulin
      degludec (n = 252) 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 severe or blood glucose-confirmed (<56 mg/dL) symptomatic
      hypoglycemic episodes during the maintenance period. Secondary end points
      included the rate of nocturnal symptomatic hypoglycemic episodes and proportion
      of patients with severe hypoglycemia during the maintenance period. The
      noninferiority criterion for the primary end point and for the secondary end
      point of nocturnal hypoglycemia was defined as an upper limit of the 2-sided 95% 
      CI for a rate ratio of 1.10 or lower; if noninferiority was established, 2-sided 
      statistical testing for superiority was conducted. Results: Of the 501 patients
      randomized (mean age, 45.9 years 53.7% men), 395 (78.8%) completed the trial.
      During the maintenance period, the rates of overall symptomatic hypoglycemia were
      2200.9 episodes per 100 person-years' exposure (PYE) in the insulin degludec
      group vs 2462.7 episodes per 100 PYE in the insulin glargine U100 group for a
      rate ratio (RR) of 0.89 (95% CI, 0.85-0.94; P < .001 for noninferiority; P < .001
      for superiority; rate difference, -130.31 episodes per 100 PYE; 95% CI, -193.5 to
      -67.16). The rates of nocturnal symptomatic hypoglycemia were 277.1 per 100 PYE
      in the insulin degludec group vs 428.6 episodes per 100 PYE in the insulin
      glargine U100 group, for an RR of 0.64 (95% CI, 0.56-0.73; P < .001 for
      noninferiority; P < .001 for superiority; rate difference, -61.94 episodes per
      100 PYE; 95% CI, -83.85 to -40.03). A lower proportion of patients in the insulin
      degludec than in the insulin glargine U100 group experienced severe hypoglycemia 
      during the maintenance period (10.3%, 95% CI, 7.3%-13.3% vs 17.1%, 95% CI,
      13.4%-20.8%, respectively; McNemar P = .002; risk difference, -6.8%; 95% CI,
      -10.8% to -2.7%). Conclusions and Relevance: Among patients with type 1 diabetes 
      and at least 1 risk factor for hypoglycemia, 32 weeks' treatment with insulin
      degludec vs insulin glargine U100 resulted in a reduced rate of overall
      symptomatic hypoglycemic episodes. Trial Registration:
      Identifier: NCT02034513.
FAU - Lane, Wendy
AU  - Lane W
AD  - Mountain Diabetes and Endocrine Center, Asheville, North Carolina.
FAU - Bailey, Timothy S
AU  - Bailey TS
AD  - AMCR Institute, Escondido, California.
FAU - Gerety, Gregg
AU  - Gerety G
AD  - Albany Medical College, Albany, New York.
FAU - Gumprecht, Janusz
AU  - Gumprecht J
AD  - Medical University of Silesia, Zabrze, Poland.
FAU - Philis-Tsimikas, Athena
AU  - Philis-Tsimikas A
AD  - Scripps Whittier Diabetes Institute, San Diego, California.
FAU - Hansen, Charlotte Thim
AU  - Hansen CT
AD  - Medical & Science, Novo Nordisk A/S, Soborg, Denmark.
FAU - Nielsen, Thor S S
AU  - Nielsen TSS
AD  - Biostatistics Insulin & Diabetes Outcomes, Novo Nordisk A/S, Soborg, Denmark.
FAU - Warren, Mark
AU  - Warren M
AD  - Physicians East PA, Greenville, North Carolina9School of Osteopathic Medicine,
      Campbell University, Lillington, North Carolina.
CN  - Group Information
LA  - eng
PT  - Journal Article
PL  - United States
JID - 7501160
EDAT- 2017/07/04 06:00
MHDA- 2017/07/04 06:00
CRDT- 2017/07/04 06:00
AID - 2635629 [pii]
AID - 10.1001/jama.2017.7115 [doi]
PST - ppublish
SO  - JAMA. 2017 Jul 4;318(1):33-44. doi: 10.1001/jama.2017.7115.