Clinical Experience with Insulin Detemir in Patients with Type 2 Diabetes from the Near East CountriesReportar como inadecuado

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Diabetes Therapy

, Volume 4, Issue 2, pp 399–408

First Online: 10 October 2013Received: 19 August 2013


IntroductionThis study aimed at determining the clinical safety and efficacy of insulin detemir IDet in combination with oral anti-diabetic drugs OADs in type 2 diabetes T2D patients from four Near East Countries Israel, Jordan, Pakistan and Lebanon.

MethodsThis prospective observational study included T2D patients previously on OADs and newly diagnosed patients initiating IDet with or without OADs, at the discretion of physicians. Safety objectives included evaluation of hypoglycemia and adverse drug reactions ADRs from baseline to Week 24. Efficacy outcomes included baseline to Week 24 changes in glucose control parameters glycated hemoglobin HbA1c, fasting plasma glucose FPG and post-breakfast post-prandial plasma glucose PPPG. Change in body weight during this period was also assessed.

ResultsA total of 2,155 patients mean ± SD: age 57.1 ± 11.0 years, BMI 29.4 ± 5.1 kg-m, average diabetes duration 9.2 ± 5.4 years were included. IDet dose at baseline was 0.20 ± 0.09 U-kg titrated up to 0.34 ± 0.14 U-kg by Week 24. From baseline to Week 24, the total number of hypoglycemic episodes increased from 1.30 to 1.37 events-patient-year, while major hypoglycemic episodes decreased from 0.15 to 0.02 events-patient-year. A total of 9 ADRs were reported, of which one event was a serious ADR. Statistically significant improvements in glucose control were reported from baseline to Week 24 HbA1c: 9.6 ± 1.6% vs. 7.6 ± 1.1%; FPG: 201.5 ± 59.5 mg-dL vs. 124.9 ± 31.6 mg-dL; PPPG: 264.2 ± 65.7 mg-dL vs. 167.2 ± 36.8 mg-dL; all p < 0.0001. Body weight did not change significantly after 24 weeks of IDet therapy.

ConclusionIDet therapy in combination with OADs improved glycemic control without increasing the risk of hypoglycemia or weight gain.

KeywordsInsulin detemir Near East Observational study Type 2 diabetes Clinical Trial Registration Number: NCT00842192.

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Autor: Akram Echtay - Anat Tsur - Mohammad I. Hasan - M. Omar Abu-Hijleh - Nidal Al Khatib - Emile Andari - Paola Atallah - Sale


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