PMID- 30349602
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200929
IS  - 1758-3780 (Electronic)
IS  - 1758-3772 (Print)
IS  - 1758-3772 (Linking)
VI  - 9
IP  - 1
DP  - 2013 Mar
TI  - Incidence of Hypoglycaemia in Patients with Type 2 Diabetes - A Subgroup Analysis 
      from the GINGER study.
PG  - 1-3
LID - 10.17925/EE.2013.09.01.1 [doi]
AB  - Introduction: The Glulisine in Combination with Insulin Glargine in an 
      Intensified Insulin Regimen (GINGER) study compared insulin glargine plus insulin 
      glulisine with premixed insulin in the treatment of patients with Type 2 diabetes 
      mellitus (T2DM). This was a post-hoc analysis of hypoglycaemia rates in subgroups 
      from the GINGER study. Methods: This analysis compared the once-daily glargine 
      plus mealtime glulisine group (n=153, four injections/day) with the overall 
      twice-daily premixed insulin group (n=157, two injections/day), which consisted 
      of two subgroups receiving either neutral protamine Hagedorn (NPH) plus regular 
      insulin (n=93) or biphasic insulin aspart 70/30 (n=63). Observed and predicted 
      hypoglycaemia rates relative to endpoint HbA(1c) for both the total population 
      and those patients who experienced >/=1 episodes of any hypoglycaemia were 
      estimated. Results: The overall hypoglycaemic event rate (episodes per 
      patient-year) for patients receiving glargine plus glulisine was numerically but 
      not significantly lower (-24.5 %) compared with the overall premixed insulin 
      group (14.0+/-24.2 versus 18.5+/-36.9; p=0.12) and significantly lower (-43.3 %) 
      compared with the biphasic insulin aspart 70/30 subgroup (24.7+/-48.5; p=0.02). In 
      patients with >/=1 episode of hypoglycaemia during treatment, the overall 
      hypoglycaemic event rate was significantly lower (-26.5 %) in patients receiving 
      glargine plus glulisine versus overall premixed insulin (18.5+/-26.3 versus 
      25.1+/-41.1; p=0.044) and significantly lower (-40.7 %) than in patients receiving 
      biphasic insulin aspart 70/30 (31.1+/-52.7; p=0.009). Glargine/glulisine treatment 
      maintained a more consistent and numerically lower hypoglycaemia rate at all 
      achieved HbA(1c) endpoints compared with premixed insulin treatment. Conclusion: 
      This post-hoc analysis of the GINGER study showed that the frequency of 
      hypoglycaemia in T2DM patients was lowered to a greater extent by insulin 
      glargine plus insulin glulisine in a comparison with premixed biphasic insulin 
      aspart 70/30 than was previously shown in a comparison with overall premixed 
      insulin. Trial Identifier: NCT00174668.
FAU - Fritsche, Andreas
AU  - Fritsche A
AD  - Fourth Medical Department and Policlinic, University Tubingen.
FAU - Hahn, Almut
AU  - Hahn A
AD  - CROMSOURCE GmbH, Aachen.
FAU - Landgraf, Wolfgang
AU  - Landgraf W
AD  - Sanofi-Aventis, Frankfurt.
AD  - Third Medical Department and Policlinic, University Dresden.
FAU - Haring, Hans-Ulrich
AU  - Haring HU
AD  - Fourth Medical Department and Policlinic, University Tubingen.
LA  - eng
SI  - ClinicalTrials.gov/NCT00174668
PT  - Journal Article
DEP - 20130404
PL  - England
TA  - Eur Endocrinol
JT  - European endocrinology
JID - 101574781
PMC - PMC6193515
OTO - NOTNLM
OT  - Basal-bolus
OT  - hypoglycaemia
OT  - insulin glargine
OT  - insulin glulisine
OT  - premixed insulin
COIS- Disclosure: The authors have no conflicts of interest to declare.
EDAT- 2013/03/01 00:00
MHDA- 2013/03/01 00:01
PMCR- 2013/03/01
CRDT- 2018/10/24 06:00
PHST- 2012/12/20 00:00 [received]
PHST- 2013/03/14 00:00 [accepted]
PHST- 2018/10/24 06:00 [entrez]
PHST- 2013/03/01 00:00 [pubmed]
PHST- 2013/03/01 00:01 [medline]
PHST- 2013/03/01 00:00 [pmc-release]
AID - 10.17925/EE.2013.09.01.1 [doi]
PST - ppublish
SO  - Eur Endocrinol. 2013 Mar;9(1):1-3. doi: 10.17925/EE.2013.09.01.1. Epub 2013 Apr 
      4.