Clinical Experience with Insulin Detemir in Patients with Type 2 Diabetes from the Near East Countries
| Autor: | Mohammad I. Hasan, Levent Sandalci, Saleem Qureshi, Bracha Dagan, Asude Ademogulları, Paola Atallah, M. Omar Abu-Hijleh, Nidal Al Khatib, Jihad Haddad, Anat Tsur, Jamal Zafar, Akram Echtay, Emile Andari |
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| Jazyk: | angličtina |
| Předmět: |
Near East
Pediatrics medicine.medical_specialty endocrine system diseases Endocrinology Diabetes and Metabolism Type 2 diabetes Observational study Diabetes mellitus Internal Medicine medicine In patient health care economics and organizations Original Research Insulin detemir Middle East business.industry nutritional and metabolic diseases medicine.disease population characteristics Clinical safety Optometry business medicine.drug |
| Zdroj: | Diabetes Therapy |
| ISSN: | 1869-6953 |
| DOI: | 10.1007/s13300-013-0041-z |
| Popis: | Introduction This 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). Methods This 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. Results A total of 2,155 patients (mean ± SD: age 57.1 ± 11.0 years, BMI 29.4 ± 5.1 kg/m2, 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 |
| Databáze: | OpenAIRE |
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