PMID- 34634390
OWN - NLM
STAT- MEDLINE
DCOM- 20211123
LR  - 20211123
IS  - 1872-8227 (Electronic)
IS  - 0168-8227 (Linking)
VI  - 181
DP  - 2021 Nov
TI  - Evaluation of the effectiveness and tolerability of gliclazide modified release 
      60 mg in patients with type 2 diabetes observing fasting during Ramadan in 
      Pakistan: An analysis from the global DIA-RAMADAN study.
PG  - 109086
LID - S0168-8227(21)00445-9 [pii]
LID - 10.1016/j.diabres.2021.109086 [doi]
AB  - AIM: To assess safety and effectiveness of gliclazide MR 60 mg in people with 
      controlled or suboptimal controlled T2DM treated with breakable gliclazide MR 
      60 mg formulation. METHOD: This study data has been extracted from an 
      international, observational study conducted in nine Asian and Middle Eastern 
      countries. Total 220 patients with T2DM were recruited from Pakistan. The primary 
      endpoint was the proportion of patients reporting at least 1 symptomatic HE, 
      whereas secondary endpoints were changes in glycosylated haemoglobin (HbA(1c)) %, 
      fasting plasma glucose (FPG) mg/dL, and body weight (kg) and proportion of 
      patients reporting any HE (confirmed or severe), between inclusion visit (V0) and 
      end of the study visit (V1). RESULTS: During Ramadan, 3.6% (n = 8/220) patients 
      had experienced at least one symptomatic HEs. A significant (p-value < 0.001) 
      reduction was observed in HbA(1c): (mean [SD]) (-0.4 [0.9] %), and body weight 
      (-0.7 [4.8] kg). Thirteen adverse events (AEs) unrelated to gliclazide MR were 
      reported during the study pre-Ramadan and post-Ramadan periods. CONCLUSION: This 
      study shows safety and effectiveness profile of gliclazide MR 60 mg by 
      emphasizing on the low risk of HEs, effective glycaemic control and body weight 
      reduction in T2DM patients, who are inclined to fasting during Ramadan.
CI  - Copyright (c) 2021 The Authors. Published by Elsevier B.V. All rights reserved.
FAU - Raza, Syed Abbas
AU  - Raza SA
AD  - National Hospital & Medical Centre, Lahore, Pakistan. Electronic address: 
      sabbasraza@hotmail.com.
FAU - Akram, Javed
AU  - Akram J
AD  - Akram Medical Complex, Lahore, Pakistan.
FAU - Aamir, Azizul Hasan
AU  - Aamir AH
AD  - Department of Diabetes and Endocrinology, Hayatabad Medical Complex, Peshawar, 
      Pakistan.
FAU - Ahmedani, Yakoob
AU  - Ahmedani Y
AD  - Baqai Institute of Diabetology and Endocrinology, Karachi, Pakistan.
FAU - Hassan, Mohammad Imtiaz
AU  - Hassan MI
AD  - Diabetic's Institute of Pakistan, Lahore, Pakistan.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20211009
PL  - Ireland
TA  - Diabetes Res Clin Pract
JT  - Diabetes research and clinical practice
JID - 8508335
RN  - 0 (Blood Glucose)
RN  - 0 (Hypoglycemic Agents)
RN  - G4PX8C4HKV (Gliclazide)
SB  - IM
MH  - Blood Glucose
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Fasting
MH  - *Gliclazide/adverse effects
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects
MH  - Islam
MH  - Pakistan
OTO - NOTNLM
OT  - Fasting
OT  - Gliclazide MR
OT  - Hypoglycaemia
OT  - Pakistan
OT  - Ramadan
OT  - Type 2 diabetes mellitus
COIS- Declaration of Competing Interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2021/10/12 06:00
MHDA- 2021/11/24 06:00
CRDT- 2021/10/11 20:13
PHST- 2021/06/14 00:00 [received]
PHST- 2021/09/27 00:00 [revised]
PHST- 2021/09/29 00:00 [accepted]
PHST- 2021/10/12 06:00 [pubmed]
PHST- 2021/11/24 06:00 [medline]
PHST- 2021/10/11 20:13 [entrez]
AID - S0168-8227(21)00445-9 [pii]
AID - 10.1016/j.diabres.2021.109086 [doi]
PST - ppublish
SO  - Diabetes Res Clin Pract. 2021 Nov;181:109086. doi: 10.1016/j.diabres.2021.109086. 
      Epub 2021 Oct 9.