Open-label, randomized study comparing basal insulin peglispro and insulin glargine, in combination with oral antihyperglycemic medications, in insulin-naïve Asian patients with type 2 diabetes.

Abstract

INTRODUCTION:

The present phase 3, randomized, open-label study compared the efficacy and safety of basal insulin peglispro with insulin glargine after 26 weeks of treatment when added to oral antihyperglycemic medications in insulin-naïve Asian patients with type 2 diabetes.

MATERIALS AND METHODS:

The primary objective was to show non-inferiority of the change in glycated hemoglobin from baseline to 26 weeks.

RESULTS:

At 26 weeks, insulin peglispro was non-inferior to glargine, meeting the primary objective. Patients receiving insulin peglispro (n = 192) showed a greater reduction in glycated hemoglobin from baseline compared with glargine (n = 196); -1.6 vs -1.4%, P = 0.005) and in fasting serum glucose (-61.2 vs -54.8 mg/dL, P = 0.02). A significantly higher proportion of patients receiving insulin peglispro achieved glycated hemoglobin <7% (57 vs 44%, P = 0.012). Insulin peglispro patients showed significantly less weight gain from baseline (1.1 vs 1.6 kg, P = 0.03). Relative rates (insulin peglispro/glargine) of total and nocturnal hypoglycemia through 26 weeks were 1.06 (P = 0.67) and 0.7 (P = 0.10), respectively. Significantly more insulin peglispro-treated patients experienced adverse events compared with glargine-treated patients (P = 0.042). Alanine aminotransferase and aspartate aminotransferase were significantly increased from baseline with insulin peglispro compared with glargine at week 26 (3.5 vs -4.6 IU/L and 2.8 vs -1.5 IU/L, respectively; P < 0.001). The incidence of injection site reactions was low and did not differ between the treatments.

DISCUSSION:

Insulin peglispro provided better glycemic control vs glargine with no differences in hypoglycemia and increased aminotransferases in insulin-naïve Asian patients with type 2 diabetes.

• Authors: Takahisa Hirose, Zhihong Cai, Kwee Poo Yeo, Makoto Imori, Kenji Ohwaki, Takeshi Imaoka
• Journal: Journal of diabetes investigation (J Diabetes Investig) Vol. 9 Issue 1 Pg. 100-107 (Jan 2018) ISSN: 2040-1124 [Electronic] Japan
• PMID: 28371567 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Chemical References

• Hypoglycemic Agents
• Insulin Lispro
• basal insulin peglispro
• Insulin Glargine
• Polyethylene Glycols

Topics

• Administration, Oral
• Asian People
• Diabetes Mellitus, Type 2 (drug therapy)
• Drug Therapy, Combination
• Female
• Humans
• Hypoglycemic Agents (administration & dosage, therapeutic use)
• Insulin Glargine (therapeutic use)
• Insulin Lispro (analogs & derivatives, therapeutic use)
• Male
• Middle Aged
• Polyethylene Glycols (therapeutic use)
• Treatment Outcome