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- Title
Comparative evaluation of pharmacokinetics and pharmacodynamics of insulin glargine (Glaritus<sup>®</sup>) and Lantus<sup>®</sup> in healthy subjects: a double-blind, randomized clamp study.
- Authors
Bhatia, Ashima; Tawade, Shraddha; Mastim, Mushtaque; Kitabi, Eliford Ngaimisi; Gopalakrishnan, Mathangi; Shah, Manish; Yeshamaina, Sridhar; Gobburu, Joga; Sahib, Maharaj; Thakur, Dipak; Prasanna Kumar, K. M.
- Abstract
Aims: The objective of the study was to compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties of an insulin glargine formulation, Glaritus® (test) with the innovator’s formulation Lantus® (reference) using the euglycemic clamp technique in a single-dose, double-blind, randomized, two sequences, four-period replicate crossover study in healthy volunteers (<italic>n</italic> = 40).Methods: Subjects received subcutaneous administration of the insulin glargine (0.4 IU/kg) formulation at two occasions for test and reference and a 20% glucose solution was infused at variable rate to maintain euglycemia for 24 h.Results: Both PK [area under the plasma concentration time curve (AUC0-24 h) and maximum insulin concentration (<italic>C</italic>max)] and PD endpoints [area under glucose infusion rate time curve (AUCGIR0-24) and maximum glucose infusion rate (GIRmax)] demonstrated bioequivalence of Glaritus to Lantus with the 90% confidence interval of geometric mean ratio of test to reference entirely contained within 0.80-1.25. Both formulations showed equivalent geometric least-square mean LSM value (0.08 nmol/L) for <italic>C</italic>max. The geometric LSM AUC0-24 h value for Glaritus® (1.09 h nmol/L) was comparable to Lantus (1.05 h nmol/L). Median <italic>T</italic>max values were also identical (12 h for both), and median t1/2 values were also equal (18 h for both). For GIR<italic>T</italic>max, the difference between the means for the two was not statistically significant. No AEs related to study formulations were reported, and both products were well tolerated.Conclusions: The test product (Glaritus) was found to be bioequivalent to the reference product (Lantus).Clinical trial registration number: CTRI/2015/06/005890; <ext-link>http://www.ctri.nic.in/</ext-link>.
- Subjects
PHARMACOKINETICS; PHARMACODYNAMICS; RANDOMIZED controlled trials; DRUG dosage; THERAPEUTIC equivalency in drugs
- Publication
Acta Diabetologica, 2018, Vol 55, Issue 5, p461
- ISSN
0940-5429
- Publication type
Article
- DOI
10.1007/s00592-018-1113-3