Safety of once-daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical practice

Stuart Ross, Grzegorz Dzida, Qiuhe Ji, Marcel Kaiser, Robert Ligthelm, Luigi Meneghini, Avideh Nazeri, Domingo Orozco-Beltran, Changyu Pan, Anne Louise Svendsen, Jean François Yale, Chang Yu Pan, Andreas Liebl, Eddy Karnieli, Salvatore Caputo, Alberto Maran, Luisa Raimundo, Sara Artola, Taner Damci, Sazi ImamogluJiten Vora, Kamlesh Khunti

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background: The aim of the present study was to identify demographic and treatment factors that were predictive of hypoglycemia in a large cohort of type 2 diabetic patients initiating insulin detemir. Methods: The present 24-week observational study of insulin initiation included 17374 participants from 10 countries. Severe hypoglycemia was defined as an event requiring third party assistance; minor hypoglycemia was defined as a daytime or nocturnal glucose measurement <3.1mmol/L. Results: Prior to initiating insulin therapy, 4.9% of the cohort reported hypoglycemia (pre-insulin hypoglycemia), with most (94.2%) reporting minor events and 9.6% reporting severe events. Compared with patients without pre-insulin hypoglycemia, those with pre-insulin hypoglycemia had a higher incidence of events of minor hypoglycemia (1.72 vs 4.46 events per patient-year [ppy], respectively), nocturnal hypoglycemia (0.25 vs 1.09 events ppy, respectively), and severe hypoglycemia (<0.01 vs 0.04 events ppy, respectively) at final visit. Age (P<0.047), body mass index (P<0.001), a prior history of microvascular disease (P<0.001), pre-insulin hypoglycemia (P<0.001), increased number of oral hypoglycemic agents (OHAs; P<0.001), OHA intensification (P<0.001), and the use of glinides (P=0.004) were all found to be independently associated with the occurrence of hypoglycemia during the study. Conclusions: Once-daily insulin detemir therapy was safe and effective, and rates of hypoglycemia were low. Concerns about hypoglycemia should not deter the initiation of basal insulin analogs.

Original languageEnglish
Pages (from-to)243-250
Number of pages8
JournalJournal of Diabetes
Volume6
Issue number3
DOIs
StatePublished - Jan 1 2014

Fingerprint

Hypoglycemia
Hypoglycemic Agents
Type 2 Diabetes Mellitus
Safety
Insulin
Insulin Detemir
Observational Studies
Body Mass Index
Therapeutics
Demography

Keywords

  • Ambulatory care
  • Basal insulin
  • Oral hypoglycemic agent
  • Sulfonylurea
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Medicine(all)

Cite this

Safety of once-daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical practice. / Ross, Stuart; Dzida, Grzegorz; Ji, Qiuhe; Kaiser, Marcel; Ligthelm, Robert; Meneghini, Luigi; Nazeri, Avideh; Orozco-Beltran, Domingo; Pan, Changyu; Svendsen, Anne Louise; Yale, Jean François; Pan, Chang Yu; Liebl, Andreas; Karnieli, Eddy; Caputo, Salvatore; Maran, Alberto; Raimundo, Luisa; Artola, Sara; Damci, Taner; Imamoglu, Sazi; Vora, Jiten; Khunti, Kamlesh.

In: Journal of Diabetes, Vol. 6, No. 3, 01.01.2014, p. 243-250.

Research output: Contribution to journalArticle

Ross, S, Dzida, G, Ji, Q, Kaiser, M, Ligthelm, R, Meneghini, L, Nazeri, A, Orozco-Beltran, D, Pan, C, Svendsen, AL, Yale, JF, Pan, CY, Liebl, A, Karnieli, E, Caputo, S, Maran, A, Raimundo, L, Artola, S, Damci, T, Imamoglu, S, Vora, J & Khunti, K 2014, 'Safety of once-daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical practice', Journal of Diabetes, vol. 6, no. 3, pp. 243-250. https://doi.org/10.1111/1753-0407.12091
Ross, Stuart ; Dzida, Grzegorz ; Ji, Qiuhe ; Kaiser, Marcel ; Ligthelm, Robert ; Meneghini, Luigi ; Nazeri, Avideh ; Orozco-Beltran, Domingo ; Pan, Changyu ; Svendsen, Anne Louise ; Yale, Jean François ; Pan, Chang Yu ; Liebl, Andreas ; Karnieli, Eddy ; Caputo, Salvatore ; Maran, Alberto ; Raimundo, Luisa ; Artola, Sara ; Damci, Taner ; Imamoglu, Sazi ; Vora, Jiten ; Khunti, Kamlesh. / Safety of once-daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical practice. In: Journal of Diabetes. 2014 ; Vol. 6, No. 3. pp. 243-250.
@article{a656f7d8edfb41458bf4b4227fffcb0b,
title = "Safety of once-daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical practice",
abstract = "Background: The aim of the present study was to identify demographic and treatment factors that were predictive of hypoglycemia in a large cohort of type 2 diabetic patients initiating insulin detemir. Methods: The present 24-week observational study of insulin initiation included 17374 participants from 10 countries. Severe hypoglycemia was defined as an event requiring third party assistance; minor hypoglycemia was defined as a daytime or nocturnal glucose measurement <3.1mmol/L. Results: Prior to initiating insulin therapy, 4.9{\%} of the cohort reported hypoglycemia (pre-insulin hypoglycemia), with most (94.2{\%}) reporting minor events and 9.6{\%} reporting severe events. Compared with patients without pre-insulin hypoglycemia, those with pre-insulin hypoglycemia had a higher incidence of events of minor hypoglycemia (1.72 vs 4.46 events per patient-year [ppy], respectively), nocturnal hypoglycemia (0.25 vs 1.09 events ppy, respectively), and severe hypoglycemia (<0.01 vs 0.04 events ppy, respectively) at final visit. Age (P<0.047), body mass index (P<0.001), a prior history of microvascular disease (P<0.001), pre-insulin hypoglycemia (P<0.001), increased number of oral hypoglycemic agents (OHAs; P<0.001), OHA intensification (P<0.001), and the use of glinides (P=0.004) were all found to be independently associated with the occurrence of hypoglycemia during the study. Conclusions: Once-daily insulin detemir therapy was safe and effective, and rates of hypoglycemia were low. Concerns about hypoglycemia should not deter the initiation of basal insulin analogs.",
keywords = "Ambulatory care, Basal insulin, Oral hypoglycemic agent, Sulfonylurea, Type 2 diabetes mellitus",
author = "Stuart Ross and Grzegorz Dzida and Qiuhe Ji and Marcel Kaiser and Robert Ligthelm and Luigi Meneghini and Avideh Nazeri and Domingo Orozco-Beltran and Changyu Pan and Svendsen, {Anne Louise} and Yale, {Jean Fran{\cc}ois} and Pan, {Chang Yu} and Andreas Liebl and Eddy Karnieli and Salvatore Caputo and Alberto Maran and Luisa Raimundo and Sara Artola and Taner Damci and Sazi Imamoglu and Jiten Vora and Kamlesh Khunti",
year = "2014",
month = "1",
day = "1",
doi = "10.1111/1753-0407.12091",
language = "English",
volume = "6",
pages = "243--250",
journal = "Journal of Diabetes",
issn = "1753-0393",
publisher = "Wiley-Blackwell",
number = "3",

}

TY - JOUR

T1 - Safety of once-daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical practice

AU - Ross, Stuart

AU - Dzida, Grzegorz

AU - Ji, Qiuhe

AU - Kaiser, Marcel

AU - Ligthelm, Robert

AU - Meneghini, Luigi

AU - Nazeri, Avideh

AU - Orozco-Beltran, Domingo

AU - Pan, Changyu

AU - Svendsen, Anne Louise

AU - Yale, Jean François

AU - Pan, Chang Yu

AU - Liebl, Andreas

AU - Karnieli, Eddy

AU - Caputo, Salvatore

AU - Maran, Alberto

AU - Raimundo, Luisa

AU - Artola, Sara

AU - Damci, Taner

AU - Imamoglu, Sazi

AU - Vora, Jiten

AU - Khunti, Kamlesh

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Background: The aim of the present study was to identify demographic and treatment factors that were predictive of hypoglycemia in a large cohort of type 2 diabetic patients initiating insulin detemir. Methods: The present 24-week observational study of insulin initiation included 17374 participants from 10 countries. Severe hypoglycemia was defined as an event requiring third party assistance; minor hypoglycemia was defined as a daytime or nocturnal glucose measurement <3.1mmol/L. Results: Prior to initiating insulin therapy, 4.9% of the cohort reported hypoglycemia (pre-insulin hypoglycemia), with most (94.2%) reporting minor events and 9.6% reporting severe events. Compared with patients without pre-insulin hypoglycemia, those with pre-insulin hypoglycemia had a higher incidence of events of minor hypoglycemia (1.72 vs 4.46 events per patient-year [ppy], respectively), nocturnal hypoglycemia (0.25 vs 1.09 events ppy, respectively), and severe hypoglycemia (<0.01 vs 0.04 events ppy, respectively) at final visit. Age (P<0.047), body mass index (P<0.001), a prior history of microvascular disease (P<0.001), pre-insulin hypoglycemia (P<0.001), increased number of oral hypoglycemic agents (OHAs; P<0.001), OHA intensification (P<0.001), and the use of glinides (P=0.004) were all found to be independently associated with the occurrence of hypoglycemia during the study. Conclusions: Once-daily insulin detemir therapy was safe and effective, and rates of hypoglycemia were low. Concerns about hypoglycemia should not deter the initiation of basal insulin analogs.

AB - Background: The aim of the present study was to identify demographic and treatment factors that were predictive of hypoglycemia in a large cohort of type 2 diabetic patients initiating insulin detemir. Methods: The present 24-week observational study of insulin initiation included 17374 participants from 10 countries. Severe hypoglycemia was defined as an event requiring third party assistance; minor hypoglycemia was defined as a daytime or nocturnal glucose measurement <3.1mmol/L. Results: Prior to initiating insulin therapy, 4.9% of the cohort reported hypoglycemia (pre-insulin hypoglycemia), with most (94.2%) reporting minor events and 9.6% reporting severe events. Compared with patients without pre-insulin hypoglycemia, those with pre-insulin hypoglycemia had a higher incidence of events of minor hypoglycemia (1.72 vs 4.46 events per patient-year [ppy], respectively), nocturnal hypoglycemia (0.25 vs 1.09 events ppy, respectively), and severe hypoglycemia (<0.01 vs 0.04 events ppy, respectively) at final visit. Age (P<0.047), body mass index (P<0.001), a prior history of microvascular disease (P<0.001), pre-insulin hypoglycemia (P<0.001), increased number of oral hypoglycemic agents (OHAs; P<0.001), OHA intensification (P<0.001), and the use of glinides (P=0.004) were all found to be independently associated with the occurrence of hypoglycemia during the study. Conclusions: Once-daily insulin detemir therapy was safe and effective, and rates of hypoglycemia were low. Concerns about hypoglycemia should not deter the initiation of basal insulin analogs.

KW - Ambulatory care

KW - Basal insulin

KW - Oral hypoglycemic agent

KW - Sulfonylurea

KW - Type 2 diabetes mellitus

UR - http://www.scopus.com/inward/record.url?scp=84898602320&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84898602320&partnerID=8YFLogxK

U2 - 10.1111/1753-0407.12091

DO - 10.1111/1753-0407.12091

M3 - Article

C2 - 24103141

AN - SCOPUS:84898602320

VL - 6

SP - 243

EP - 250

JO - Journal of Diabetes

JF - Journal of Diabetes

SN - 1753-0393

IS - 3

ER -