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Clinical Experience with Insulin Detemir in Patients with Type 2 Diabetes from the Near East Countries

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...

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Autores principales: Echtay, Akram, Tsur, Anat, Hasan, Mohammad I., Abu-Hijleh, M. Omar, Al Khatib, Nidal, Andari, Emile, Atallah, Paola, Qureshi, Saleem, Zafar, Jamal, Sandalci, Levent, Ademogulları, Asude, Haddad, Jihad, Dagan, Bracha
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3889319/
https://www.ncbi.nlm.nih.gov/pubmed/24108581
http://dx.doi.org/10.1007/s13300-013-0041-z
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author Echtay, Akram
Tsur, Anat
Hasan, Mohammad I.
Abu-Hijleh, M. Omar
Al Khatib, Nidal
Andari, Emile
Atallah, Paola
Qureshi, Saleem
Zafar, Jamal
Sandalci, Levent
Ademogulları, Asude
Haddad, Jihad
Dagan, Bracha
author_facet Echtay, Akram
Tsur, Anat
Hasan, Mohammad I.
Abu-Hijleh, M. Omar
Al Khatib, Nidal
Andari, Emile
Atallah, Paola
Qureshi, Saleem
Zafar, Jamal
Sandalci, Levent
Ademogulları, Asude
Haddad, Jihad
Dagan, Bracha
author_sort Echtay, Akram
collection PubMed
description 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 [HbA(1c)], 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/m(2), 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 (HbA(1c): 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. CONCLUSION: IDet therapy in combination with OADs improved glycemic control without increasing the risk of hypoglycemia or weight gain.
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spelling pubmed-38893192014-01-14 Clinical Experience with Insulin Detemir in Patients with Type 2 Diabetes from the Near East Countries Echtay, Akram Tsur, Anat Hasan, Mohammad I. Abu-Hijleh, M. Omar Al Khatib, Nidal Andari, Emile Atallah, Paola Qureshi, Saleem Zafar, Jamal Sandalci, Levent Ademogulları, Asude Haddad, Jihad Dagan, Bracha Diabetes Ther Original Research 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 [HbA(1c)], 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/m(2), 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 (HbA(1c): 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. CONCLUSION: IDet therapy in combination with OADs improved glycemic control without increasing the risk of hypoglycemia or weight gain. Springer Healthcare 2013-10-10 2013-12 /pmc/articles/PMC3889319/ /pubmed/24108581 http://dx.doi.org/10.1007/s13300-013-0041-z Text en © The Author(s) 2013 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Research
Echtay, Akram
Tsur, Anat
Hasan, Mohammad I.
Abu-Hijleh, M. Omar
Al Khatib, Nidal
Andari, Emile
Atallah, Paola
Qureshi, Saleem
Zafar, Jamal
Sandalci, Levent
Ademogulları, Asude
Haddad, Jihad
Dagan, Bracha
Clinical Experience with Insulin Detemir in Patients with Type 2 Diabetes from the Near East Countries
title Clinical Experience with Insulin Detemir in Patients with Type 2 Diabetes from the Near East Countries
title_full Clinical Experience with Insulin Detemir in Patients with Type 2 Diabetes from the Near East Countries
title_fullStr Clinical Experience with Insulin Detemir in Patients with Type 2 Diabetes from the Near East Countries
title_full_unstemmed Clinical Experience with Insulin Detemir in Patients with Type 2 Diabetes from the Near East Countries
title_short Clinical Experience with Insulin Detemir in Patients with Type 2 Diabetes from the Near East Countries
title_sort clinical experience with insulin detemir in patients with type 2 diabetes from the near east countries
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3889319/
https://www.ncbi.nlm.nih.gov/pubmed/24108581
http://dx.doi.org/10.1007/s13300-013-0041-z
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