PMID- 38355814
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240318
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 15
IP  - 3
DP  - 2024 Mar
TI  - Real-World Study on Effectiveness of Insulin Glargine U300 After Oral 
      Antidiabetic Drug Failure in Patients with Type 2 Diabetes in the Gulf Region.
PG  - 691-704
LID - 10.1007/s13300-024-01537-2 [doi]
AB  - INTRODUCTION: The effectiveness and safety of long-acting insulin glargine U300 
      (Gla-300), in patients with type 2 diabetes mellitus (T2DM) requiring insulin, 
      has not been reported in the Gulf region. METHODS: Insulin-naive patients with 
      T2DM, uncontrolled on OADs, and prescribed Gla-300 were followed up in a 12-month 
      prospective observational study. Gla-300 was titrated to glycemic targets. The 
      primary endpoint (achieving glycemic targets) was evaluated at month 6 of 
      treatment. The need for treatment intensification, safety, and patient-reported 
      outcomes (PRO) were also reported. RESULTS: The study included 412 patients 
      (61.7% men; age 52.2 +/- 11.1 years and T2DM duration 10.7 +/- 6.8 years). Almost 50% 
      were on more than 3 OADs, mostly biguanides, sulfonylureas, and 
      dipeptidyl-peptidase-4 inhibitors. Baseline HbA1c level was 9.2% +/- 1.1% and 
      targets were set at 6.9% +/- 0.4%. Baseline fasting plasma glucose was 
      11.5 +/- 3.8 mmol/l. Fifty-seven patients (13.8%) achieved glycemic targets at 
      month 6, hindered by baseline HbA1c >/= 10%, frequent co-morbidities, older age, 
      suburban/rural residence, and full-time employment. Levels of HbA1c dropped 
      progressively by 0.96% +/- 0.07% (month 3), 1.29% +/- 0.08% (month 6), and 
      1.76% +/- 0.06% (month 12). Gla-300 dose was 17.0 +/- 9.0 IU/day at baseline, 
      24.6 +/- 9.6 IU/day at month 3, 28.5 +/- 9.9 IU/day at month 6, and 
      30.7 +/- 10.7 IU/day at month 12. Three patients experienced non-severe 
      hypoglycemia and a slight decrease in body weight and PROs improved. CONCLUSIONS: 
      In the Gulf, Gla-300 in patients with T2DM uncontrolled on OADs improved glycemic 
      control, with low rates of hypoglycemia and improved PROs. Gla-300 dose 
      up-titration from baseline to month 6 did not, however, result in a vast 
      proportion of patients achieving their pre-determined HbA1c targets. TRIAL 
      REGISTRATION: ClinicalTrials.gov identifier: NCT03703869.
CI  - (c) 2024. The Author(s).
FAU - Khan, Niaz E
AU  - Khan NE
AD  - Imperial College London Diabetes Centre, Al Ain, United Arab Emirates.
FAU - Al Shaikh, AbdulRahman A M
AU  - Al Shaikh AAM
AD  - King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
FAU - Hassoun, Ahmed A K
AU  - Hassoun AAK
AD  - Dubai Diabetes Center, Dubai, United Arab Emirates.
FAU - Hassan, Amr M
AU  - Hassan AM
AD  - Sanofi, Dubai, United Arab Emirates.
FAU - Salah, Mona M
AU  - Salah MM
AD  - Al Garhoud Hospital, Dubai, United Arab Emirates.
FAU - Al Abdella, Nabeela A
AU  - Al Abdella NA
AD  - Taiba Hospital, Jabriya, Kuwait.
FAU - Safarini, Saher S M
AU  - Safarini SSM
AD  - Dallah Hospital, An Nakheel, Riyadh, Saudi Arabia.
FAU - Al Dahi, Waleed A
AU  - Al Dahi WA
AD  - Mubarak Hospital, Jabriya, Kuwait.
FAU - Akil, Yasser A
AU  - Akil YA
AUID- ORCID: 0000-0002-1472-6721
AD  - Sanofi, Gulf Countries, Jeddah, Saudi Arabia. Yasser.Akil@sanofi.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT03703869
PT  - Journal Article
DEP - 20240215
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC10942942
OTO - NOTNLM
OT  - Gla-300
OT  - Gulf region
OT  - Individualized HbA1c targets
OT  - Insulin-naive patients
OT  - Treatment satisfaction
OT  - Type 2 diabetes mellitus
COIS- Amr M. Hassan and Yasser A. Akil are Sanofi employees, with financial interests 
      in the Company. Authors Niaz E. Khan, AbdulRahman A. M. Al Shaikh, Ahmed A. K. 
      Hassoun, Mona M. Salah, Nabeela A. Al Abdella, Saher S. M. Safarini, and Waleed 
      A. Al Dahi declare no conflict of interest.
EDAT- 2024/02/15 00:42
MHDA- 2024/02/15 00:43
PMCR- 2024/02/15
CRDT- 2024/02/14 23:55
PHST- 2023/11/24 00:00 [received]
PHST- 2024/01/19 00:00 [accepted]
PHST- 2024/02/15 00:43 [medline]
PHST- 2024/02/15 00:42 [pubmed]
PHST- 2024/02/14 23:55 [entrez]
PHST- 2024/02/15 00:00 [pmc-release]
AID - 10.1007/s13300-024-01537-2 [pii]
AID - 1537 [pii]
AID - 10.1007/s13300-024-01537-2 [doi]
PST - ppublish
SO  - Diabetes Ther. 2024 Mar;15(3):691-704. doi: 10.1007/s13300-024-01537-2. Epub 2024 
      Feb 15.