title: Efficacy and safety of liraglutide therapy in 195 Indian patients with type 2 diabetes in real world setting.
abstract: BACKGROUND
  GLP-1 analogues has established role in the management of type 2 diabetes mellitus (T2DM). Liraglutide, a human GLP-1 analogue is used as an adjunct to diet and exercise in adults with T2DM for improvement of glycemic control.
  
  
  OBJECTIVE
  To assess the efficacy and safety of liraglutide in Indian patients with T2DM in real-world setting.
  
  
  METHODS
  A prospective, open label, single arm, single centre, observational study of 24 weeks duration in a real-world setting. Subjects with T2DM with impaired glucose control despite of antidiabetic therapy and clinically suitable for liraglutide therapy were enrolled and managed. All subjects received liraglutide therapy in addition to their existing anti-diabetic therapy. Starting dose of liraglutide (Victoza) was 0.6 mg/day for 7 days followed by 1.2 mg/day for next 7 days and finally 1.8 mg/day for 22 weeks. Subjects were evaluated at baseline and at 24 weeks. Adverse events (AE) noted during course of therapy were recorded. Student t test (two tailed, dependent) was performed for assessment of statistical significance.
  
  
  RESULTS
  Total 195 subjects were studied over 24 weeks. Mean fasting plasma glucose (FPG) was decreased from 163.81 mg/dL to 111.6 (P<0.001); similarly HbA1c was reduced from 8.14% to 6.96% (P=0.006) at 24 weeks. At week 24, 49.23% and 41.03% subjects treated with liraglutide reached an HbA1c<7.0% and ≤6.5%, respectively. Mean weight was reduced from 86.41 kg to 82.37 kg (P<0.001). Additionally mean systolic and diastolic blood pressure was reduced from 129.31 and 76.18 mm of Hg to 119.59 (P=0.90) and 70.88 (P<0.001) mm of Hg, respectively. Serum cholesterol was reduced from 166.68 mg/dL to 124.86 mg/dL (P<0.001). Twenty-two (11.28%) subjects reported adverse events (AE), the most common AEs being vomiting, tiredness, loose motion and nausea. All AEs were mild to moderate in nature without any serious AE.
  
  
  CONCLUSIONS
  In 195 Indian patients with T2DM receiving anti-diabetic drugs, addition of liraglutide resulted in significant improvement in glycemic parameters and was well tolerated. Clinically significant reduction in weight, blood pressure and serum cholesterol were also noted.
authors.affiliation: Jothydev's Diabetes Research Centre, Trivandrum, Kerala, India(1). Electronic address: jothydev@gmail.com.
authors.forename: Jothydev
authors.initials: J
authors.lastname: Kesavadev
authors.affiliation: Jothydev's Diabetes Research Centre, Trivandrum, Kerala, India(1).
authors.forename: Arun
authors.initials: A
authors.lastname: Shankar
authors.affiliation: Jothydev's Diabetes Research Centre, Trivandrum, Kerala, India(1).
authors.forename: Gopikakrishnan
authors.initials: G
authors.lastname: Gopalakrishnan
authors.affiliation: Jothydev's Diabetes Research Centre, Trivandrum, Kerala, India(1).
authors.forename: Sunitha
authors.initials: S
authors.lastname: Jothydev
mesh_terms: D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D001794:Blood Pressure; D002784:Cholesterol / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000453:epidemiology; D004038:Diet, Reducing / Q000379:methods*; D004334:Drug Administration Schedule; D015444:Exercise; D005260:Female; D052216:Glucagon-Like Peptide 1 / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006442:Glycated Hemoglobin / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007194:India / Q000453:epidemiology; D000069450:Liraglutide; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects; D044465:White People
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D002784:Cholesterol; D052216:Glucagon-Like Peptide 1; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000069450:Liraglutide; C517652:hemoglobin A1c protein, human
keywords: India; Liraglutide; Type 2 Diabetes