PMID- 25483023
OWN - NLM
STAT- MEDLINE
DCOM- 20160302
LR  - 20150608
IS  - 1878-1780 (Electronic)
IS  - 1262-3636 (Linking)
VI  - 41
IP  - 3
DP  - 2015 Jun
TI  - Similar glucose control with basal-bolus regimen of insulin detemir plus insulin 
      aspart and thrice-daily biphasic insulin aspart 30 in insulin-naive patients with 
      type 2 diabetes: Results of a 50-week randomized clinical trial of stepwise 
      insulin intensification.
PG  - 223-30
LID - S1262-3636(14)00176-1 [pii]
LID - 10.1016/j.diabet.2014.11.002 [doi]
AB  - OBJECTIVE: This study aimed to demonstrate the non-inferiority of 50-week 
      treatment with stepwise insulin intensification of basal-bolus insulin analogues 
      [insulin detemir (IDet) and aspart (IAsp)] versus biphasic insulin aspart 30 
      (BIAsp30) in insulin-naive type 2 diabetes mellitus (T2DM) patients not 
      controlled by oral glucose-lowering drugs (OGLDs). RESEARCH DESIGN AND METHODS: 
      In this open-label multicentre, multinational, randomized, parallel-arm 
      treat-to-target trial, 403 insulin-naive patients with T2DM in four African 
      countries were randomized to either an IDet+IAsp (n = 200) or BIAsp1-2-3 (n = 
      203) treatment group. Stepwise insulin intensification was performed at the end 
      of 14, 26 and 38 weeks, depending on HbA1c values. The primary endpoint was 
      change in HbA1c after 50 weeks of treatment. Safety variables were hypoglycaemia 
      incidence, occurrence of adverse events and weight gain. RESULTS: Non-inferiority 
      of the IDet+IAsp versus BIAsp1-2-3 treatment regimen was demonstrated by their 
      similar HbA1c levels at the end of trial (IDet+IAsp: baseline 8.6%, 50 weeks 
      7.4%; BIAsp1-2-3: baseline 8.7%, 50 weeks 7.3%; full analysis set difference: 
      0.1% [95% CI: -0.1, 0.3]; per protocol: 0.2% [95% CI: -0.1, 0.4]). At week 50, 
      40.3 and 44.9% of patients achieved HbA1c <7.0% with IDet+IAsp and BIAsp1-2-3, 
      respectively. The rate of overall hypoglycaemia during the trial was also similar 
      in both groups (IDet+IAsp: 9.4 events/patient-year; BIAsp1-2-3: 9.8 
      events/patient-year). CONCLUSION: Insulin initiation and intensification using 
      IDet+IAsp was not inferior to BIAsp1-2-3 in insulin-naive patients with T2DM not 
      controlled by OGLDs. Both regimens led to similar reductions in HbA1c values 
      after 50 weeks of treatment.
CI  - Copyright (c) 2014 Elsevier Masson SAS. All rights reserved.
FAU - Malek, R
AU  - Malek R
AD  - Internal Medicine Department, Saadna University Hospital, Setif, Algeria. 
      Electronic address: rmalekdz@gmail.com.
FAU - Ajili, F
AU  - Ajili F
AD  - Department of Internal Medicine, Military Hospital of Tunis, Tunis, Tunisia.
FAU - Assaad-Khalil, S H
AU  - Assaad-Khalil SH
AD  - Faculty of Medicine, Alexandria University, Alexandria, Egypt.
FAU - Shinde, A
AU  - Shinde A
AD  - Novo Nordisk Pharma Gulf, FZ LLC, Dubai, United Arab Emirates.
FAU - Chen, J W
AU  - Chen JW
AD  - Novo Nordisk Region International Operations A/S, Zurich, Switzerland.
FAU - Van den Berg, E
AU  - Van den Berg E
AD  - Zuid-Afrikaanse Hospital, Muckleneuk, Pretoria, South Africa.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20141204
PL  - France
TA  - Diabetes Metab
JT  - Diabetes & metabolism
JID - 9607599
RN  - 0 (Biphasic Insulins)
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (insulin aspart, insulin aspart protamine drug combination 30:70)
RN  - 4FT78T86XV (Insulin Detemir)
RN  - 53027-39-7 (Insulin, Isophane)
RN  - D933668QVX (Insulin Aspart)
SB  - IM
MH  - Adult
MH  - Africa
MH  - Biphasic Insulins/administration & dosage/pharmacology/*therapeutic use
MH  - Blood Glucose/*drug effects
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/pharmacology/*therapeutic use
MH  - Insulin Aspart/administration & dosage/pharmacology/*therapeutic use
MH  - Insulin Detemir/administration & dosage/pharmacology/*therapeutic use
MH  - Insulin, Isophane/administration & dosage/pharmacology/*therapeutic use
MH  - Male
MH  - Middle Aged
OTO - NOTNLM
OT  - Basal-bolus insulin
OT  - Biphasic insulin aspart
OT  - Insulin detemir
OT  - Insulin intensification
OT  - Premixed insulin
OT  - Type 2 diabetes
EDAT- 2014/12/09 06:00
MHDA- 2016/03/05 06:00
CRDT- 2014/12/09 06:00
PHST- 2014/07/03 00:00 [received]
PHST- 2014/10/31 00:00 [revised]
PHST- 2014/11/07 00:00 [accepted]
PHST- 2014/12/09 06:00 [entrez]
PHST- 2014/12/09 06:00 [pubmed]
PHST- 2016/03/05 06:00 [medline]
AID - S1262-3636(14)00176-1 [pii]
AID - 10.1016/j.diabet.2014.11.002 [doi]
PST - ppublish
SO  - Diabetes Metab. 2015 Jun;41(3):223-30. doi: 10.1016/j.diabet.2014.11.002. Epub 
      2014 Dec 4.