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El Shiekh AR, Farrag HA, Ashour T, et al. Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study. Indian J Endocrinol Metab. 2016;20(4):443-50doi: 10.4103/2230-8210.183461.
El Shiekh, A. R., Farrag, H. A., Ashour, T., Alshali, K. Z., & AbdelFattah, W. (2016). Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study. Indian journal of endocrinology and metabolism, 20(4), 443-50. https://doi.org/10.4103/2230-8210.183461
El Shiekh, Abdel Rahman, et al. "Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study." Indian journal of endocrinology and metabolism vol. 20,4 (2016): 443-50. doi: https://doi.org/10.4103/2230-8210.183461
El Shiekh AR, Farrag HA, Ashour T, Alshali KZ, AbdelFattah W. Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study. Indian J Endocrinol Metab. 2016 Jul-Aug;20(4):443-50. doi: 10.4103/2230-8210.183461. PMID: 27366709; PMCID: PMC4911832.
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Indian J Endocrinol Metab. 2016 Jul-Aug;20(4):443-50. doi: 10.4103/2230-8210.183461.

Clinical safety of insulin detemir in patients with Type 2 diabetes in the Gulf countries: The multicenter, noninterventional, open-label LevSafe study.

Indian journal of endocrinology and metabolism

Abdel Rahman El Shiekh, Hesham A Farrag, Tarek Ashour, Khalid Zaki Alshali, Waleed AbdelFattah

Affiliations

  1. Department of Internal Medicine and Endocrinology, King Abdulaziz University, Jeddah, Chairman of Saudi Scientific Diabetes Society, Saudi Arabia.
  2. Department of Internal Medicine, Saudi Airlines Medical Services, Jeddah, Saudi Arabia.
  3. Department of Internal Medicine, Security Forces Hospital, Riyadh, Saudi Arabia.
  4. Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
  5. Clinical, Medical, and Quality Department, Novo Nordisk Pharma Gulf, Riyadh, Saudi Arabia.

PMID: 27366709 PMCID: PMC4911832 DOI: 10.4103/2230-8210.183461

Abstract

AIM: 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).

CONCLUSION: 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.

Keywords: Gulf; LevSafe; Type 2 diabetes; insulin detemir; noninterventional study

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