title: Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study.
abstract: OBJECTIVE
  To evaluate the safety profile of insulin detemir (IDet) in people with Type 2 diabetes mellitus (T2DM) in the Gulf countries in the 32-week, noninterventional LevSafe study.
  
  
  METHODS
  People with T2DM whose physicians had opted to start IDet therapy were included in the study. Safety parameters, including serious adverse drug reactions (SADRs) and hypoglycemia, and changes in body weight and glycemic control were evaluated at baseline, week 16 and week 32.
  
  
  RESULTS
  A total of 686 patients were exposed to IDet therapy with a mean (±standard deviation) age, body mass index, and diabetes duration of 51.3 ± 11.0 years, 31.3 ± 5.5 kg/m(2), and 10.2 ± 6.1 years, respectively. The mean total daily dose of IDet was 32.0 ± 32.8 U at baseline and 44.7 ± 60.7 U at week 32. No SADRs were reported during the study. Total hypoglycemia decreased from 435 events at baseline to 204 events at week 32 (mean change analyzed by Wilcoxon signed rank test: -0.34; P = 0.0115), and no major hypoglycemia was reported at week 32. Over the 32-week treatment period, the mean body weight decreased from 85.7 ± 15.2 kg to 85.4 ± 14.5 kg (P = 0.0203), glycated hemoglobin A1c from 9.9 ± 1.67% to 7.7 ± 1.36% (P < 0.0001), and fasting plasma glucose from 11.9 ± 3.27 mmol/L to 7.4 ± 1.85 mmol/L (P < 0.0001).
  
  
  CONCLUSIONS
  IDet therapy was well-tolerated and was associated with a decreased number of hypoglycemic events and improved glycemic control after 32 weeks in patients with T2DM in the Gulf countries.
authors.affiliation: Department of Internal Medicine and Endocrinology, King Abdulaziz University, Jeddah, Chairman of Saudi Scientific Diabetes Society, Saudi Arabia.
authors.forename: Abdel Rahman
authors.initials: AR
authors.lastname: El Shiekh
authors.affiliation: Department of Internal Medicine, Saudi Airlines Medical Services, Jeddah, Saudi Arabia.
authors.forename: Hesham A
authors.initials: HA
authors.lastname: Farrag
authors.affiliation: Department of Internal Medicine, Security Forces Hospital, Riyadh, Saudi Arabia.
authors.forename: Tarek
authors.initials: T
authors.lastname: Ashour
authors.affiliation: Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
authors.forename: Khalid Zaki
authors.initials: KZ
authors.lastname: Alshali
authors.affiliation: Clinical, Medical, and Quality Department, Novo Nordisk Pharma Gulf, Riyadh, Saudi Arabia.
authors.forename: Waleed
authors.initials: W
authors.lastname: AbdelFattah
keywords: Gulf; LevSafe; Type 2 diabetes; insulin detemir; noninterventional study