PMID- 29183844
OWN - NLM
STAT- MEDLINE
DCOM- 20180504
LR  - 20221207
IS  - 1872-8227 (Electronic)
IS  - 0168-8227 (Linking)
VI  - 135
DP  - 2018 Jan
TI  - Original paper: Efficacy and safety analysis of insulin degludec/insulin aspart 
      compared with biphasic insulin aspart 30: A phase 3, multicentre, international, 
      open-label, randomised, treat-to-target trial in patients with type 2 diabetes 
      fasting during Ramadan.
PG  - 218-226
LID - S0168-8227(17)31598-X [pii]
LID - 10.1016/j.diabres.2017.11.027 [doi]
AB  - AIMS: To compare the efficacy and safety of insulin degludec/insulin aspart 
      (IDegAsp) and biphasic insulin aspart 30 (BIAsp 30) before, during and after 
      Ramadan in patients with type 2 diabetes mellitus (T2DM) who fasted during 
      Ramadan. METHODS: In this multinational, randomised, treat-to-target trial, 
      patients with T2DM who intended to fast and were on basal, pre- or self-mixed 
      insulin +/- oral antidiabetic drugs for >/=90 days were randomised (1:1) to IDegAsp 
      twice daily (BID) or BIAsp 30 BID. Treatment period included pre-Ramadan 
      treatment initiation (with insulin titration for 8-20 weeks), Ramadan (4 weeks) 
      and post-Ramadan (4 weeks). Insulin doses were reduced by 30-50% for the pre-dawn 
      meal (suhur) on the first day of Ramadan, and readjusted to the pre-Ramadan 
      levels at the end of Ramadan. Hypoglycaemia was analysed as overall (severe or 
      plasma glucose <3.1 mmol/L [56 mg/dL]), nocturnal (00:01-05:59) or severe 
      (requiring assistance of another person). RESULTS: During the treatment period, 
      IDegAsp (n = 131) had significantly lower overall and nocturnal hypoglycaemia 
      rates with similar glycaemic efficacy, versus BIAsp 30 (n = 132). During Ramadan, 
      despite achieving significantly lower pre-iftar (meal at sunset) self-measured 
      plasma glucose (estimated treatment difference: -0.54 mmol/L [-1.02; -0.07](95% 
      CI), p = .0247; post hoc) with similar overall glycaemic efficacy, IDegAsp showed 
      significantly lower overall and nocturnal hypoglycaemia rates versus BIAsp 30. 
      CONCLUSIONS: IDegAsp is a suitable therapeutic agent for patients who need 
      insulin for sustained glucose control before, during and after Ramadan fasting, 
      with a significantly lower risk of hypoglycaemia, versus BIAsp 30, an existing 
      premixed insulin analogue.
CI  - Copyright (c) 2017. Published by Elsevier B.V.
FAU - Hassanein, Mohamed
AU  - Hassanein M
AD  - Endocrine Department, Dubai Hospital, Dubai Health Authority, Dubai, United Arab 
      Emirates. Electronic address: mhassanein148@hotmail.com.
FAU - Echtay, Akram Salim
AU  - Echtay AS
AD  - Internal Medicine Department, Head Division of Endocrinology, Rafic Hariri 
      University Hospital, Bir Hassan, Jinah, POB: 5244, 2833-7401, Beirut, Lebanon. 
      Electronic address: akramechtay2@gmail.com.
FAU - Malek, Rachid
AU  - Malek R
AD  - Department of Internal Medicine, CHU Setif, 19000, Algeria. Electronic address: 
      rmalekdz@gmail.com.
FAU - Omar, Mahomed
AU  - Omar M
AD  - Department of Diabetes and Endocrinology, University of KwaZulu Natal, Durban, 
      South Africa. Electronic address: momars@telkomsa.net.
FAU - Shaikh, Shehla Sajid
AU  - Shaikh SS
AD  - Department of Endocrinology, Prince Aly Khan Hospital, Mumbai, India. Electronic 
      address: drshehla@rediffmail.com.
FAU - Ekelund, Magnus
AU  - Ekelund M
AD  - Novo Nordisk A/S, Vandtaarnsvej 114, DK 2860, Soborg, Denmark. Electronic 
      address: muek@novonordisk.com.
FAU - Kaplan, Kadriye
AU  - Kaplan K
AD  - Novo Nordisk A/S, Vandtaarnsvej 114, DK 2860, Soborg, Denmark. Electronic 
      address: kdka@novonordisk.com.
FAU - Kamaruddin, Nor Azmi
AU  - Kamaruddin NA
AD  - UKM Medical Centre, National University of Malaysia, Jalan Yaacob Latif, Bandar 
      Tun Razal, Cheras Kuala Lumpur, Malaysia. Electronic address: 
      dr.nor.azmi@gmail.com.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20171126
PL  - Ireland
TA  - Diabetes Res Clin Pract
JT  - Diabetes research and clinical practice
JID - 8508335
RN  - 0 (Drug Combinations)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin, Long-Acting)
RN  - 0 (insulin degludec, insulin aspart drug combination)
RN  - D933668QVX (Insulin Aspart)
SB  - IM
MH  - Adult
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Drug Administration Schedule
MH  - Drug Combinations
MH  - Fasting/*blood
MH  - Female
MH  - Glycated Hemoglobin/analysis/*drug effects/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/pharmacology/*therapeutic use
MH  - Insulin Aspart/pharmacology/*therapeutic use
MH  - Insulin, Long-Acting/pharmacology/*therapeutic use
MH  - Male
MH  - Middle Aged
OTO - NOTNLM
OT  - Biphasic insulin aspart 30
OT  - Hypoglycaemia
OT  - Insulin degludec/insulin aspart
OT  - Ramadan fasting
OT  - Type 2 diabetes
EDAT- 2017/12/01 06:00
MHDA- 2018/05/05 06:00
CRDT- 2017/11/30 06:00
PHST- 2017/10/05 00:00 [received]
PHST- 2017/11/08 00:00 [accepted]
PHST- 2017/12/01 06:00 [pubmed]
PHST- 2018/05/05 06:00 [medline]
PHST- 2017/11/30 06:00 [entrez]
AID - S0168-8227(17)31598-X [pii]
AID - 10.1016/j.diabres.2017.11.027 [doi]
PST - ppublish
SO  - Diabetes Res Clin Pract. 2018 Jan;135:218-226. doi: 
      10.1016/j.diabres.2017.11.027. Epub 2017 Nov 26.