PMID- 22036246
OWN - NLM
STAT- MEDLINE
DCOM- 20120313
LR  - 20221207
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 33
IP  - 11
DP  - 2011 Nov
TI  - Efficacy and safety of prandial premixed therapy using insulin lispro mix 50/50 3 
      times daily compared with progressive titration of insulin lispro mix 75/25 or 
      biphasic insulin aspart 70/30 twice daily in patients with type 2 diabetes 
      mellitus: a randomized, 16-week, open-label study.
PG  - 1682-93
LID - 10.1016/j.clinthera.2011.10.001 [doi]
AB  - BACKGROUND: Prandial premixed therapy 3 times daily has been proposed recently 
      for type 2 diabetes mellitus (T2DM) patients who fail to achieve glycemic control 
      with commonly used premixed insulin analogs, insulin lispro mix 75/25 (LM75/25) 
      and biphasic insulin aspart 70/30 (BIAsp70/30) BID. OBJECTIVE: The aim of this 
      work was to compare the efficacy and safety of 3-times daily insulin lispro mix 
      50/50 (TID group) with progressive titration of twice-daily LM75/25 or BIAsp70/30 
      (BID group) administered along with metformin in T2DM patients. METHODS: This was 
      an open-label, 16-week, multicenter, randomized, parallel trial. End point 
      glycosylated hemoglobin (HbA(1c)) was the primary efficacy measure; HbA(1c) 
      reduction from baseline to end point, percentage of patients reaching target 
      HbA(1c) (<7.0% and </=6.5%), postprandial blood glucose (BG), and BG excursions 
      after lunch were secondary measures. Safety was evaluated by collecting adverse 
      events. RESULTS: A total of 302 patients with mean (SD) age 57.7 (9.27) years, 
      diabetes duration 11.2 (6.47) years, HbA(1c) 8.5% (1.23), fasting BG 184.0 
      (53.04) mg/dL, body weight 86.8 (14.79) kg, body mass index 31.7 (4.23) kg/m(2), 
      and daily insulin dose  approximately 48 IU were randomized. No significant difference was 
      observed in end point HbA(1c) between the 2 groups. Seven-point BG profiles 
      showed lower fasting and postbreakfast BG in the BID group but lower postlunch BG 
      in the TID group. Daily insulin dose change was similar in both groups, with more 
      weight gain in the TID group (P = 0.0009). Overall hypoglycemic rates were 
      similar in both groups, but nocturnal hypoglycemia was more frequent in the BID 
      group (P = 0.0063). CONCLUSIONS: In patients with T2DM who have not achieved 
      adequate glycemic control with LM75/25 and BiAsp70/30 BID plus metformin and who 
      are not candidates for basal bolus therapy, switching either to treatment with 
      LM50/50 TID or to progressive titration of premix insulin analogs BID did not 
      produce sufficient evidence of a difference of overall glycemic control between 
      the 2 treatment groups. Short study duration and less intensive dose adjustments 
      might have contributed to these results.
CI  - Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.
FAU - Farcasiu, Eugenia
AU  - Farcasiu E
AD  - NC Paulescu National Diabetes, Nutrition, and Metabolic Diseases Institute, 
      Bucharest, Romania.
FAU - Ivanyi, Tibor
AU  - Ivanyi T
FAU - Mozejko-Pastewka, Barbara
AU  - Mozejko-Pastewka B
FAU - Birkus, Zita
AU  - Birkus Z
FAU - Csog, Jozsef
AU  - Csog J
FAU - Kowalska, Irina
AU  - Kowalska I
FAU - Coetzer, Thomas Frederic
AU  - Coetzer TF
FAU - Bulgurlu, Sami
AU  - Bulgurlu S
FAU - Schinzel, Birgit
AU  - Schinzel B
FAU - Kiljanski, Jacek
AU  - Kiljanski J
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20111027
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin Lispro)
RN  - D933668QVX (Insulin Aspart)
SB  - IM
MH  - Blood Glucose/analysis
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Drug Administration Schedule
MH  - Eating
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Insulin Aspart/administration & dosage/adverse effects/*therapeutic use
MH  - Insulin Lispro/administration & dosage/adverse effects/*therapeutic use
MH  - Male
EDAT- 2011/11/01 06:00
MHDA- 2012/03/14 06:00
CRDT- 2011/11/01 06:00
PHST- 2011/09/29 00:00 [accepted]
PHST- 2011/11/01 06:00 [entrez]
PHST- 2011/11/01 06:00 [pubmed]
PHST- 2012/03/14 06:00 [medline]
AID - S0149-2918(11)00672-2 [pii]
AID - 10.1016/j.clinthera.2011.10.001 [doi]
PST - ppublish
SO  - Clin Ther. 2011 Nov;33(11):1682-93. doi: 10.1016/j.clinthera.2011.10.001. Epub 
      2011 Oct 27.