PMID- 30952575
OWN - NLM
STAT- MEDLINE
DCOM- 20191219
LR  - 20221207
IS  - 1590-3729 (Electronic)
IS  - 0939-4753 (Linking)
VI  - 29
IP  - 5
DP  - 2019 May
TI  - Italian Titration Approach Study (ITAS) with insulin glargine 300 U/mL in 
      insulin-naive type 2 diabetes: Design and population.
PG  - 496-503
LID - S0939-4753(19)30028-6 [pii]
LID - 10.1016/j.numecd.2019.01.011 [doi]
AB  - BACKGROUND AND AIMS: Fostering patient's self-managing of basal insulin therapy 
      could improve glucose control, by removing patient's and physician's barriers to 
      basal insulin initiation, titration and glucose monitoring. The Italian Titration 
      Approaches Study (ITAS) aims at demonstrating non-inferiority (<0.3% margin) in 
      efficacy of glucose control (change in glycated hemoglobin [HbA1c] after 24 
      weeks) by the same titration algorithm of insulin glargine 300 U/mL (Gla-300), 
      managed by the (nurse assisted) patient versus the physician, in insulin naive 
      patients with Type 2 Diabetes Mellitus (T2DM), uncontrolled with previous 
      treatments. METHODS AND RESULTS: ITAS is a phase IV, 24-week, national, 
      multicenter, open label, randomized (1:1) parallel group study. 458 patients were 
      enrolled, 359 randomized, and 339 completed the study, in 46 Italian centers. 
      Baseline characteristics and previous medications of the ITT population (N = 355) 
      are reported. Mean +/- SD age, T2DM duration, HbA1c, FPG and BMI were 64.0 +/- 9.8 
      years, 11.6 +/- 7.6 years, 8.79 +/- 0.65%, 170.9 +/- 42.3 mg/dL, and 
      30.3 +/- 5.6 kg/m(2), respectively. Vascular and metabolic disorders were most 
      frequent (73.8% and 58.3%, respectively). More than 90% of patients were on 
      metformin. CONCLUSION: ITAS is the first study to compare two different managers 
      (nurse-assisted patient vs physician) of the same titration algorithm of Gla-300 
      in insulin naive patients with T2DM in unsatisfactory glucose control. This study 
      might provide novel evidence on the efficacy/effectiveness of patient-managed 
      titration algorithm of Gla-300 in a pragmatic setting and may reduce barriers to 
      basal insulin initiation and its titration.
CI  - Copyright (c) 2019. Published by Elsevier B.V.
FAU - Bonadonna, R C
AU  - Bonadonna RC
AD  - Division of Endocrinology and Metabolic Diseases, Department of Medicine and 
      Surgery, University of Parma, AOU of Parma, Italy. Electronic address: 
      riccardo.bonadonna@unipr.it.
FAU - Giaccari, A
AU  - Giaccari A
AD  - Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome and Universita 
      Cattolica del Sacro Cuore, Rome, Italy.
FAU - Buzzetti, R
AU  - Buzzetti R
AD  - Sapienza University of Rome, Italy.
FAU - Aimaretti, G
AU  - Aimaretti G
AD  - University of the Eastern Piedmont, Italy.
FAU - Cucinotta, D
AU  - Cucinotta D
AD  - University of Messina, Italy.
FAU - Avogaro, A
AU  - Avogaro A
AD  - University of Padua, Italy.
FAU - Perseghin, G
AU  - Perseghin G
AD  - University of Milan Bicocca, Italy.
FAU - Larosa, M
AU  - Larosa M
AD  - Sanofi, Milan, Italy.
FAU - Bolli, G B
AU  - Bolli GB
AD  - Section of Endocrinology and Metabolism, Department of Medicine, Perugia 
      University Medical School, Italy.
FAU - Fanelli, C G
AU  - Fanelli CG
AD  - Section of Endocrinology and Metabolism, Department of Medicine, Perugia 
      University Medical School, Italy.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Equivalence Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20190208
PL  - Netherlands
TA  - Nutr Metab Cardiovasc Dis
JT  - Nutrition, metabolism, and cardiovascular diseases : NMCD
JID - 9111474
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (hemoglobin A1c protein, human)
RN  - 2ZM8CX04RZ (Insulin Glargine)
SB  - IM
EIN - Nutr Metab Cardiovasc Dis. 2019 Aug;29(8):869-870. PMID: 31257093
MH  - Aged
MH  - Biomarkers/blood
MH  - Blood Glucose/*drug effects/metabolism
MH  - Diabetes Mellitus, Type 2/blood/diagnosis/*drug therapy/nursing
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage/adverse effects
MH  - Insulin Glargine/*administration & dosage/adverse effects
MH  - Italy
MH  - Male
MH  - Middle Aged
MH  - Nurse's Role
MH  - Patient Participation
MH  - Physician's Role
MH  - *Self Care
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Insulin glargine 300 U/mL
OT  - Insulin titration
OT  - Patient empowerment
OT  - Type 2 diabetes
EDAT- 2019/04/07 06:00
MHDA- 2019/12/20 06:00
CRDT- 2019/04/07 06:00
PHST- 2018/09/15 00:00 [received]
PHST- 2019/01/03 00:00 [revised]
PHST- 2019/01/17 00:00 [accepted]
PHST- 2019/04/07 06:00 [pubmed]
PHST- 2019/12/20 06:00 [medline]
PHST- 2019/04/07 06:00 [entrez]
AID - S0939-4753(19)30028-6 [pii]
AID - 10.1016/j.numecd.2019.01.011 [doi]
PST - ppublish
SO  - Nutr Metab Cardiovasc Dis. 2019 May;29(5):496-503. doi: 
      10.1016/j.numecd.2019.01.011. Epub 2019 Feb 8.