Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes: A randomized, open-label clinical trial

Autor: Gregory T. Golm, Roy Eldor, Wendy L. Carofano, Priscilla Hollander, Raymond L. H. Lam, Baptist Gallwitz, Julio Rosenstock, Michael F. Crutchlow, Marc Rendell, Philip Home, Michael C. Marcos
Rok vydání: 2018
Předmět:
Blood Glucose
Male
medicine.medical_specialty
Endocrinology
Diabetes and Metabolism
medicine.medical_treatment
Insulin Antibodies
Insulin Glargine
030209 endocrinology & metabolism
Type 2 diabetes
030204 cardiovascular system & hematology
Gastroenterology
03 medical and health sciences
0302 clinical medicine
Endocrinology
Internal medicine
Internal Medicine
medicine
Humans
Hypoglycemic Agents
cardiovascular diseases
Least-Squares Analysis
Adverse effect
Aged
Glycated Hemoglobin
Insulin glargine
business.industry
Insulin
nutritional and metabolic diseases
Type 2 Diabetes Mellitus
Middle Aged
medicine.disease
Hypoglycemia
Clinical trial
Treatment Outcome
Tolerability
Diabetes Mellitus
Type 2
lipids (amino acids
peptides
and proteins)
Female
Open label
business
hormones
hormone substitutes
and hormone antagonists
Algorithms
medicine.drug
Zdroj: Diabetes, obesitymetabolism. 20(9)
ISSN: 1463-1326
Popis: Aim To compare the efficacy and safety of MK-1293 insulin glargine (Mk-Gla) and Lantus (Sa-Gla) in people with type 2 diabetes mellitus (T2DM). Materials and methods This Phase 3, randomized, active-controlled, open-label, 24-week clinical trial (ClinicalTrials.gov number NCT02059187) enrolled 531 participants with T2DM (HbA1c ≤11.0%) either eligible for or currently taking basal insulin (≥10 U/day). Participants were randomized 1:1 to once-daily Mk-Gla (n = 263) or Sa-Gla (n = 263). Titration of insulin was guided by a fasting plasma glucose (FPG)-based dosing algorithm. The primary efficacy objective was to demonstrate the non-inferiority of change from baseline in HbA1c (margin of 0.40% [4.4 mmol/mol]) with Mk-Gla versus Sa-Gla after 24 weeks. The primary safety objective was anti-insulin antibody development after 24 weeks. Results For Mk-Gla and Sa-Gla, the least squares (LS) mean HbA1c change from baseline (95% CI) was -1.28 (-1.41, -1.15)% (-14.0 [-15.4, -12.6] mmol/mol) and -1.30 (-1.43, -1.18)% (-14.2 [-15.6, -12.8] mmol/mol). The LS mean HbA1c difference (Mk-Gla minus Sa-Gla) was 0.03 (-0.12, 0.18)% (0.3 [-1.4, 1.9] mmol/mol), meeting non-inferiority and equivalence (secondary objective) criteria. Insulin doses, FPG, and seven-point plasma glucose profiles were similar between groups. Safety and tolerability, including anti-insulin antibody responses, hypoglycaemia, adverse events and body weight, were similar between insulins. The efficacy and safety of Mk-Gla and Sa-Gla were similar both in participants who were insulin-treated or insulin-naive at baseline. Conclusions Mk-Gla and Sa-Gla demonstrated similar efficacy and safety over 24 weeks of treatment in people with T2DM.
Databáze: OpenAIRE
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