PMID- 27867889
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200930
IS  - 2230-8210 (Print)
IS  - 2230-9500 (Electronic)
IS  - 2230-9500 (Linking)
VI  - 20
IP  - 6
DP  - 2016 Nov-Dec
TI  - Liraglutide effect and action in diabetes-In (LEAD-In): A prospective 
      observational study assessing safety and effectiveness of liraglutide in patients 
      with type 2 diabetes mellitus treated under routine clinical practice conditions 
      in India.
PG  - 838-845
AB  - BACKGROUND: This 26-week, open-label observational study assessed the incidence 
      and type of adverse events (AEs) associated with liraglutide use according to the 
      standard clinical practice settings and the local label in India. MATERIALS AND 
      METHODS: A total of 1416 adults with type 2 diabetes (T2D) treated with 
      liraglutide in 125 sites across India were included in the study. Participants 
      were newly diagnosed or already receiving antidiabetic medications. Safety and 
      efficacy data were collected at baseline and at approximately weeks 13 and 26. 
      The primary outcome was incidence and type of AEs while using liraglutide, with 
      events classified by Medical Dictionary for Regulatory Activities system organ 
      class and preferred term. The secondary objective was to assess other clinical 
      parameters related to effective T2D management. RESULTS: Twenty AEs, 
      predominately gastrointestinal, were reported in 1.3% of the study population in 
      scheduled visits up to week 26. No serious AEs, including death, were reported. 
      Hypoglycemic episodes were reported in 7.3% of participants at baseline and 0.7% 
      at week 26. No major hypoglycemic events were reported up to week 26 (baseline: 
      0.4%). Glycated hemoglobin was reduced from baseline (8.8 +/- 1.3%) to week 26 by 
      1.6 +/- 1.1% (P < 0.0001); significant improvements in fasting blood glucose, and 
      2-h postprandial blood glucose (post-breakfast, -lunch, and -dinner) were also 
      observed. Mean body weight decreased by 8.1 +/- 6.5 kg from baseline (92.5 +/- 14.6 
      kg; P < 0.0001). CONCLUSIONS: From the number of AEs reported, it is suggested 
      that liraglutide was well tolerated in subjects with T2D treated under standard 
      clinical practice conditions in India. Liraglutide was effective, and no new 
      safety concerns were identified.
FAU - Wangnoo, Subhash Kumar
AU  - Wangnoo SK
AD  - Apollo Centre of Obesity, Diabetes and Endocrinology, Indraprastha Apollo 
      Hospital, New Delhi, India.
FAU - Kumar, Surender
AU  - Kumar S
AD  - Department of Endocrinology and Metabolism, Sir Ganga Ram Hospital, New Delhi, 
      India.
FAU - Bhattacharyya, Arpandev
AU  - Bhattacharyya A
AD  - Department of Endocrinology, Manipal Hospital, Bengaluru, Karnataka, India.
FAU - Tripathi, Sudhir
AU  - Tripathi S
AD  - Clinical, Medical and Regulatory Department, Novo Nordisk Pharma Gulf FZ-LLC, 
      Dubai, United Arab Emirates.
FAU - Akhtar, Shahid
AU  - Akhtar S
AD  - Clinical, Medical and Regulatory Department, Novo Nordisk Pharma Gulf FZ-LLC, 
      Dubai, United Arab Emirates.
FAU - Shetty, Raman
AU  - Shetty R
AD  - Clinical, Medical and Regulatory Department, Novo Nordisk Pharma Gulf FZ-LLC, 
      Dubai, United Arab Emirates.
FAU - Ghosal, Samit
AU  - Ghosal S
AD  - Department of Diabetology, Nightingale Hospital, Kolkata, West Bengal, India.
LA  - eng
PT  - Journal Article
PL  - India
TA  - Indian J Endocrinol Metab
JT  - Indian journal of endocrinology and metabolism
JID - 101555690
PMC - PMC5105570
OTO - NOTNLM
OT  - Adverse events
OT  - India
OT  - liraglutide
OT  - real-world
OT  - routine clinical practice
OT  - type 2 diabetes
EDAT- 2016/11/22 06:00
MHDA- 2016/11/22 06:01
PMCR- 2016/11/01
CRDT- 2016/11/22 06:00
PHST- 2016/11/22 06:00 [entrez]
PHST- 2016/11/22 06:00 [pubmed]
PHST- 2016/11/22 06:01 [medline]
PHST- 2016/11/01 00:00 [pmc-release]
AID - IJEM-20-838 [pii]
AID - 10.4103/2230-8210.189232 [doi]
PST - ppublish
SO  - Indian J Endocrinol Metab. 2016 Nov-Dec;20(6):838-845. doi: 
      10.4103/2230-8210.189232.