TITLE:
Evaluation of Safety and Efficacy of Glaritus® versus Lantus® in Combination with Insulin Lispro among Adults with Type 1 Diabetes Mellitus-Phase IV Study
AUTHORS:
Gaurav Puppalwar, Sandesh Sawant, Bhimsen Silgiri, Kirti Shukla, Hanmant Barkate
KEYWORDS:
Diabetes Mellitus, Insulin Glargine, Insulin Lispro
JOURNAL NAME:
Open Journal of Endocrine and Metabolic Diseases,
Vol.7 No.4,
April
30,
2017
ABSTRACT:
Objective: The present study assessed safety and efficacy of Glaritus® among
adults with Type 1 Diabetes Mellitus (T1DM). Methodology: This prospective,
randomized, multicenter, comparative, non-inferiority, open-label, parallel
group, phase IV study was conducted in 14 study centers in India. Subjects
were randomly allocated to receive either Glaritus® or Lantus® for 12
weeks. Each week, the dose of insulin was titrated to maintain target fasting
blood glucose (FBG) level range of 80 - 120 mg/dL. Results: A total of 171
subjects were randomized (Glaritus® arm-86; Lantus® arm-85) and 161 subjects
completed the study. The mean change in the glycosylated haemoglobin
(HbA1c) levels from visit 3 (baseline) to visit 6 (end of trial) in Glaritus® arm
was -0.69 ± 1.81 and in Lantus® arm was -0.53 ± 1.94. The mean change in
glucose levels between week 1 and end of week 11 in Glaritus® arm was -8.81
± 34.57 and in Lantus® arm was -5.28 ± 30. At least one hypoglycemic episode
was experienced by 27.2% subjects of Glaritus® arm and 28.6% subjects of
Lantus® arm. A total of 24 adverse events (AEs) such as pain, pyrexia, few infection
related including urinary tract infections, metabolic related such as
decreased appetite, musculoskeletal, neurological and skin related were reported
in the study (Lantus® arm: 14 AEs; Glaritus® arm: 10 AEs). Conclusion: In this short term, 12-week study, biosimilar insulin glargine, Glaritus®,
is comparable to the reference product, Lantus®, when combined with Insulin
Lispro® in terms of glycemic control, risk of hypoglycemia and occurrence of
adverse drug reactions among adults with T1DM.