Biphasic insulin Aspart 30 vs. NPH plus regular human insulin in type 2 diabetes patients; a cost-effectiveness study.
BACKGROUND
The aim of this study was to compare the efficacy, safety, costs, and cost-effectiveness of biphasic insulin aspart 30 (BIAsp 30) with NPH plus regular human insulin (NPH/Reg) in patients with type 2 diabetes mellitus (T2DM).


METHODS
It was a Single-center, parallel-group, randomized, clinical trial (Trial Registration: NCT01889095). One hundred and seventy four T2DM patients with poorly controlled diabetes (HbA1c ≥ 8 % (63.9 mmol/mol)) were randomly assigned to trial arms (BIAsp 30 and NPH/Reg) and were followed up for 48 weeks. BIAsp 30 was started at an initial dose of 0.2-0.6 IU/Kg in two divided doses and was titrated according to the glycemic status of the patient. Similarly, NPH/Reg insulin was initiated at a dose of 0.2-0.6 IU/Kg with a 2:1 ratio and was subsequently titrated. Level of glycemic control, hypoglycemic events, direct and indirect costs, quality adjusted life year (QALY) and incremental cost-effectiveness ratio have been assessed.


RESULTS
HbA1c, Fasting plasma glucose (FPG), and two-hour post-prandial glucose (PPG) were improved in both groups during the study (P < 0.05 for all analyses). Lower frequencies of minor, major, and nocturnal hypoglycemic episodes were observed with BIAsp 30 (P < 0.05). Additionally, BIAsp 30 was associated with less weight gain and also higher QALYs (P < 0.05). Total medical and non-medical costs were significantly lower with BIAsp 30 as compared with NPH/Reg (930.55 ± 81.43 USD vs. 1101.24 ± 165.49 USD, P = 0.004). Moreover, BIAsp 30 showed lower ICER as a dominant alternative.


CONCLUSIONS
Despite being more expensive, BIAsp 30 offers the same glycemic control as to NPH/Reg dose-dependently and also appears to cause fewer hypoglycemic events and to be more cost-effective in Iranian patients with type 2 diabetes.
Department of Pharmacoeconomics and Pharmaceutical Administration, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Amir
A
Farshchi
Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran.
Rokhsareh
R
Aghili
Pharmaceutical Sciences branch, Islamic Azad University, Tehran, Iran.
Maryam
M
Oskuee
Pharmaceutical Sciences branch, Islamic Azad University, Tehran, Iran.
Marjan
M
Rashed
Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, P.O. Box 13145-784, Tehran, Iran.
Sina
S
Noshad
Department of Pharmacoeconomics and Pharmaceutical Administration, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Abbas
A
Kebriaeezadeh
Department of Internal Medicine, Dr. Ziaeian Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Maryam
M
Kia
Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, P.O. Box 13145-784, Tehran, Iran. esteghamati@tums.ac.ir.
Alireza
A
Esteghamati
D061265:Biphasic Insulins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001786:Blood Glucose; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D016527:Drug Costs; D006442:Glycated Hemoglobin / Q000378:metabolism; D007003:Hypoglycemia / Q000453:epidemiology; D061267:Insulin Aspart / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007336:Insulin, Isophane / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D061265:Biphasic Insulins; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D061267:Insulin Aspart; D007336:Insulin, Isophane; C517652:hemoglobin A1c protein, human; C557564:insulin aspart, insulin aspart protamine drug combination 30:70
Biphasic insulin aspart 30; Cost; Cost-effectiveness and QALY; Insulin; Type 2 diabetes mellitus