PMID- 32006641
OWN - NLM
STAT- MEDLINE
DCOM- 20200723
LR  - 20200723
IS  - 1872-8227 (Electronic)
IS  - 0168-8227 (Linking)
VI  - 162
DP  - 2020 Apr
TI  - Effectiveness, safety, and tolerability of vildagliptin or vildagliptin/metformin 
      combination in patients with type 2 diabetes uncontrolled on insulin therapy in a 
      real-world setting in Egypt: The OMEGA study.
PG  - 108042
LID - S0168-8227(19)30846-0 [pii]
LID - 10.1016/j.diabres.2020.108042 [doi]
AB  - PURPOSE: To evaluate the effectiveness and safety of vildagliptin or 
      vildagliptin/metformin combination among patients with type 2 diabetes mellitus 
      (T2DM) uncontrolled on insulin in a real-world setting in Egypt. METHODS: This 
      12-week, prospective, observational study enrolled T2DM patients. Primary 
      endpoint was mean change in glycated hemoglobin (HbA1c) from baseline to Week 12. 
      Secondary endpoints included mean change in body weight, insulin dosage and 
      safety after 12 weeks. RESULTS: Of the 90 patients enrolled, 88 (93.6%) completed 
      the study. The mean age was 54.7 years; men, 51.1%; body mass index (BMI), 
      31.6 kg/m(2); T2DM duration, 89.8 months; insulin dose, 55.14 IU/day. At 
      12 weeks, HbA1c decreased significantly with vildagliptin/metformin (-1.3 +/- 0.9%, 
      p < 0.0001) and vildagliptin (-1.1 +/- 0.9%, p = 0.0001). 27.1% and 11.1% achieved 
      HbA1c <7% in vildagliptin/metformin and vildagliptin groups, respectively. 
      Significant mean (+/-standard deviation [SD]) reduction in body weight 
      (-2.5 +/- 7.3 kg, p = 0.0055) and insulin dose (-24.11 +/- 22.3 IU, p < 0.0001) was 
      observed in the vildagliptin/metformin group. Overall, 8 (8.9%) patients reported 
      11 (12.2%) adverse events (AEs) and no hypoglycemic events. AEs possibly related 
      to the study drug (4.2%, in vildagliptin/metformin) were mild in severity. 
      CONCLUSION: Vildagliptin with/without metformin as an add-on to insulin resulted 
      in good glycemic control and was well tolerated without any hypoglycemic events.
CI  - Copyright (c) 2020. Published by Elsevier B.V.
FAU - El Ebrashy, Ibrahim
AU  - El Ebrashy I
AD  - Faculty of Medicine, Cairo University, Cairo, Egypt.
FAU - El Kafrawy, Nabil
AU  - El Kafrawy N
AD  - Faculty of Medicine, Menoufia University, Al-Menoufia, Egypt. Electronic address: 
      alkafrawy_nabil@hotmail.com.
FAU - Raouf, Rana
AU  - Raouf R
AD  - Novartis Pharma S.A.E., Cairo, Egypt.
FAU - Yousry, Diana
AU  - Yousry D
AD  - Novartis Pharma S.A.E., Cairo, Egypt.
LA  - eng
PT  - Journal Article
DEP - 20200130
PL  - Ireland
TA  - Diabetes Res Clin Pract
JT  - Diabetes research and clinical practice
JID - 8508335
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 9100L32L2N (Metformin)
RN  - I6B4B2U96P (Vildagliptin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/therapeutic use
MH  - Drug Therapy, Combination/*methods
MH  - Egypt
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/pharmacology/*therapeutic use
MH  - Insulin/pharmacology/*therapeutic use
MH  - Male
MH  - Metformin/pharmacology/*therapeutic use
MH  - Middle Aged
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Vildagliptin/pharmacology/*therapeutic use
MH  - Young Adult
OTO - NOTNLM
OT  - Dipeptidyl peptidase-4 inhibitor
OT  - Insulin
OT  - Metformin
OT  - Real-world
OT  - Type 2 diabetes mellitus
OT  - Vildagliptin
COIS- Declaration of Competing Interest EIE: Received honoraria for lectures and 
      advisory boards from Eli Lilly, Novartis Pharmaceuticals, AstraZeneca, Novo 
      Nordisk, Servier, Boehringer Ingelheim, Merck Serono, Merck Sharp & Dohme 
      Limited, Sanofi-Aventis, EVA Pharma, Pfizer and Amgen. KNE: Received honoraria 
      for lectures and advisory boards from Eli Lilly, Novartis Pharmaceuticals, 
      AstraZeneca, Novo Nordisk, Servier, Boehringer Ingelheim, Merck Serono, Merck 
      Sharp & Dohme Limited, Sanofi-Aventis and EVA Pharma. RR is employee of Novartis. 
      DY is currently working as a medical scientific liaison at Sandoz Egypt Pharma 
      S.A.E.
EDAT- 2020/02/02 06:00
MHDA- 2020/07/24 06:00
CRDT- 2020/02/02 06:00
PHST- 2019/06/19 00:00 [received]
PHST- 2020/01/17 00:00 [revised]
PHST- 2020/01/27 00:00 [accepted]
PHST- 2020/02/02 06:00 [pubmed]
PHST- 2020/07/24 06:00 [medline]
PHST- 2020/02/02 06:00 [entrez]
AID - S0168-8227(19)30846-0 [pii]
AID - 10.1016/j.diabres.2020.108042 [doi]
PST - ppublish
SO  - Diabetes Res Clin Pract. 2020 Apr;162:108042. doi: 10.1016/j.diabres.2020.108042. 
      Epub 2020 Jan 30.