PMID- 27660663
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160923
LR  - 20201001
IS  - 1758-5996 (Print)
IS  - 1758-5996 (Electronic)
IS  - 1758-5996 (Linking)
VI  - 8
DP  - 2016
TI  - Insulin lispro low mixture twice daily vs basal insulin glargine once daily and 
      prandial insulin lispro once daily as insulin intensification strategies in 
      patients with type 2 diabetes: Latin American subpopulation analysis of a 
      randomized trial.
PG  - 69
LID - 10.1186/s13098-016-0163-3 [doi]
LID - 69
AB  - BACKGROUND: This post hoc analysis examined the efficacy and safety of 
      twice-daily insulin lispro low mixture (LM25) and once-daily basal insulin 
      glargine plus once-daily prandial insulin lispro (IGL) in a Latin American 
      subpopulation with type 2 diabetes mellitus (T2DM). METHODS: A phase 4, 
      randomized, open-label, parallel-arm trial included participants aged 18-75 years 
      with T2DM taking once-daily insulin glargine and stable doses of metformin and/or 
      pioglitazone with glycated hemoglobin (HbA1c) 7.5-10.5 % and fasting plasma 
      glucose </=121 mg/dL. Participants were randomized 1:1 to receive their stable dose 
      of metformin and/or pioglitazone plus twice-daily LM25 or IGL for 24 weeks. The 
      primary efficacy outcome was change in HbA1c after 24 weeks of treatment. Results 
      from participants in Argentina, Brazil, and Mexico are presented here. RESULTS: 
      162 participants (80 LM25; 82 IGL) with mean +/- standard deviation (SD) 
      age = 57.3 +/- 9.0 years and body mass index = 31.3 +/- 5.2 kg/m(2) were included. 
      Mean +/- SD change in HbA1c from baseline to week 24 was -1.5 +/- 1.0 % (LM25) and 
      -1.1 +/- 1.2 % (IGL). At week 24, 35.1 % (LM25) and 31.6 % (IGL) of participants 
      achieved HbA1c <7.0 %. Mean +/- SD weight gain from baseline to week 24 was 
      2.4 +/- 2.9 kg in the LM25 group and 1.0 +/- 3.1 kg in the IGL group. The mean +/- SD 
      rates of total hypoglycemia per year were 18.9 +/- 27.3 (LM25) and 
      21.6 +/- 31.1 (IGL). Rates of treatment-emergent adverse events were 46 % (LM25) 
      and 39 % (IGL). CONCLUSIONS: Our results suggest that both LM25 and IGL are 
      viable treatment options for insulin intensification in Latin American patients 
      with T2DM with suboptimal glycemic control on basal insulin glargine. The safety 
      and tolerability profiles of LM25 and IGL are consistent between this Latin 
      American population and the global trial-level population. Trial registration 
      NCT01175824.
FAU - Rojas, Arturo
AU  - Rojas A
AD  - Direccion-investigacion, Servicio Medico Nutricional S.C. (Centro de Diabetes de 
      Coatzacoalcos), Revolucion # 522, 96400 Coatzacoalcos, VER Mexico.
FAU - Sposetti, Georgina
AU  - Sposetti G
AD  - Diabetes and Metabolism Research Department, Head en Instituto de Investigaciones 
      Clinicas, Mar del Plata, Argentina.
FAU - Gross, Jorge L
AU  - Gross JL
AD  - Centro de Pesquisas em Diabetes, Porto Alegre, Rio Grande do Sul Brazil.
FAU - Barbieri, Douglas Eugenio
AU  - Barbieri DE
AD  - Eli Lilly do Brasil Ltda, Sao Paulo, Brazil.
FAU - Duan, Ran
AU  - Duan R
AD  - Eli Lilly, Indianapolis, USA.
FAU - Linetzky, Bruno
AU  - Linetzky B
AD  - Eli Lilly Interamerica Inc., Buenos Aires, Argentina.
FAU - De Lana, Janaina Martins
AU  - De Lana JM
AD  - Eli Lilly do Brasil Ltda, Sao Paulo, Brazil.
FAU - Stempa, Oded
AU  - Stempa O
AD  - Eli Lilly and Co, Mexico City, Mexico.
FAU - Rodriguez, Angel
AU  - Rodriguez A
AD  - Lilly Spain, Alcobendas, Spain.
LA  - eng
SI  - ClinicalTrials.gov/NCT01175824
PT  - Journal Article
DEP - 20160917
PL  - England
TA  - Diabetol Metab Syndr
JT  - Diabetology & metabolic syndrome
JID - 101488958
PMC - PMC5027076
OTO - NOTNLM
OT  - Diabetes mellitus, type 2
OT  - Insulin intensification
OT  - Insulin lispro
OT  - Insulin lispro mixture
OT  - Latin America
EDAT- 2016/09/24 06:00
MHDA- 2016/09/24 06:01
PMCR- 2016/09/17
CRDT- 2016/09/24 06:00
PHST- 2015/12/09 00:00 [received]
PHST- 2016/07/10 00:00 [accepted]
PHST- 2016/09/24 06:00 [entrez]
PHST- 2016/09/24 06:00 [pubmed]
PHST- 2016/09/24 06:01 [medline]
PHST- 2016/09/17 00:00 [pmc-release]
AID - 163 [pii]
AID - 10.1186/s13098-016-0163-3 [doi]
PST - epublish
SO  - Diabetol Metab Syndr. 2016 Sep 17;8:69. doi: 10.1186/s13098-016-0163-3. 
      eCollection 2016.