PMID- 27578616
OWN - NLM
STAT- MEDLINE
DCOM- 20170307
LR  - 20221207
IS  - 1878-0334 (Electronic)
IS  - 1871-4021 (Linking)
VI  - 11
IP  - 1
DP  - 2017 Jan-Mar
TI  - Titration of basal insulin or immediate addition of rapid acting insulin in 
      patients not at target using basal insulin supported oral antidiabetic treatment 
      - A prospective observational study in 2202 patients.
PG  - 51-57
LID - S1871-4021(16)30135-7 [pii]
LID - 10.1016/j.dsx.2016.08.006 [doi]
AB  - AIM: Optimal treatment intensification strategies in patients with type-2 
      diabetes mellitus (T2DM) receiving basal insulin supported oral antidiabetic 
      therapy (BOT) remain controversial. The objective of the present study was to 
      compare outcomes of BOT-intensification by either the uptitration of long-acting 
      insulin glargine or by the immediate addition of a rapid acting insulin analogue 
      (RAIA). METHODS: This was a prospective, observational, 24-week study in T2DM 
      patients with BOT using insulin glargine and baseline glycated hemoglobin (HbA1c) 
      between 7.0 and 8.5%. Patients were stratified by their physicians to one of the 
      following treatment intensification strategies: Basal insulin titration to target 
      with discretionary subsequent addition of RAIA at weeks 12 or 24 (GLAR), or 
      immediate addition of RAIA at baseline (GLARplus). RESULTS: A total of 3266 
      patients were prescreened of whom 2202 fulfilled the selection criteria. Of 
      these, 1684 patients were documented in the GLAR group and 518 in the GLARplus 
      group. In the GLAR group, in 91 (5.5%) and 21 patients (1.3%) RAIA was added at 
      weeks 12 and 24, respectively. The groups displayed similar baseline 
      characteristics; except, mean diabetes duration was slightly shorter in the GLAR 
      group (8.7 vs. 9.4 years). During the study, insulin glargine dose was increased 
      from 18.7 to 26.4U (plus 7.7U) in GLAR and from 24.9 to 27.3U (plus 2.4U) in 
      GLARplus patients. Mean RAIA dose was 9.6+/-4.7U at the final visit. After 24 
      weeks, HbA1c was reduced by 0.8 and 0.9% in the GLAR and GLARplus groups, 
      respectively (both p<0.001). An HbA1c of </=7.0% was achieved in 49.2% of GLAR and 
      48.5% of GLARplus patients. In both groups, we observed improvements in 
      cardiovascular risk factors such as lipids and blood pressure. The rates of 
      symptomatic (1.6 vs. 1.7%) and severe (0.18 vs. 0.19%) hypoglycemic episodes were 
      low and comparable in both groups. CONCLUSION: These findings provide evidence 
      that treatment intensification in patients with type 2 diabetes not at glycemic 
      target on BOT with insulin glargine is equally safe and effective using either 
      long-acting insulin titration alone or the addition of a rapid-acting insulin 
      analogue.
CI  - Copyright (c) 2016 Diabetes India. Published by Elsevier Ltd. All rights reserved.
FAU - Siegmund, Thorsten
AU  - Siegmund T
AD  - Department for Endocrinology, Diabetes and Metabolism, Isar Klinikum Munchen 
      GmbH, Sonnen Str. 24-26, 80331 Munich, Germany. Electronic address: 
      thorsten.siegmund@isarklinikum.de.
FAU - Pfohl, Martin
AU  - Pfohl M
AD  - Evang. Krankenhaus BETHESDA GmbH, Heerstrasse 219, 47053 Duisburg, Germany. 
      Electronic address: martin.pfohl@o2online.de.
FAU - Forst, Thomas
AU  - Forst T
AD  - Profil Institut fur Stoffwechselforschung GmbH, Hellersbergerstrasse 9, 41460 
      Neuss, Germany. Electronic address: Thomas.Forst@Profil.com.
FAU - Pscherer, Stefan
AU  - Pscherer S
AD  - Klinik fur Innere Medizin III, Sophien- und Hufeland-Klinikum, 
      Henry-van-de-Velde-Strasse 2, 99425 Weimar, Germany. Electronic address: 
      stefan.pscherer@t-online.de.
FAU - Bramlage, Peter
AU  - Bramlage P
AD  - Institut fur Pharmakologie und Praventive Medizin, Menzelstrasse 21, 15831 Mahlow, 
      Germany. Electronic address: peter.bramlage@ippmed.de.
FAU - Foersch, Johannes
AU  - Foersch J
AD  - Medical Department, Sanofi, Potsdamer Strasse 8, 10785 Berlin, Germany. Electronic 
      address: johannes.foersch@sanofi.com.
FAU - Borck, Anja
AU  - Borck A
AD  - Medical Department, Sanofi, Potsdamer Strasse 8, 10785 Berlin, Germany. Electronic 
      address: anja.borck@sanofi.com.
FAU - Seufert, Jochen
AU  - Seufert J
AD  - Universitatsklinikum Freiburg, Hugstetter Strasse 55, 79106 Germany. Electronic 
      address: jochen.seufert@uniklinik-freiburg.de.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20160824
PL  - Netherlands
TA  - Diabetes Metab Syndr
JT  - Diabetes & metabolic syndrome
JID - 101462250
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Insulin, Long-Acting)
RN  - 0 (Insulin, Short-Acting)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Biomarkers/analysis
MH  - Blood Glucose/analysis
MH  - Diabetes Mellitus, Type 2/complications/*drug therapy
MH  - Female
MH  - Follow-Up Studies
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hyperglycemia/chemically induced
MH  - Hypoglycemia/chemically induced
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Insulin/*analogs & derivatives/*therapeutic use
MH  - Insulin, Long-Acting/therapeutic use
MH  - Insulin, Short-Acting/therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Prognosis
MH  - Prospective Studies
MH  - Young Adult
OTO - NOTNLM
OT  - BOT
OT  - Diabetes
OT  - HbA1c
OT  - Hypoglycaemia
OT  - Long acting insulin
OT  - Rapid acting insulin
EDAT- 2016/09/01 06:00
MHDA- 2017/03/08 06:00
CRDT- 2016/09/01 06:00
PHST- 2016/06/17 00:00 [received]
PHST- 2016/08/22 00:00 [accepted]
PHST- 2016/09/01 06:00 [pubmed]
PHST- 2017/03/08 06:00 [medline]
PHST- 2016/09/01 06:00 [entrez]
AID - S1871-4021(16)30135-7 [pii]
AID - 10.1016/j.dsx.2016.08.006 [doi]
PST - ppublish
SO  - Diabetes Metab Syndr. 2017 Jan-Mar;11(1):51-57. doi: 10.1016/j.dsx.2016.08.006. 
      Epub 2016 Aug 24.