The safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) in Iranians with type 2 diabetes: an open-label, non-randomised, multi-centre observational study--the Iran subgroup of the IMPROVE™ study.
BACKGROUND
To evaluate the clinical profile of BIAsp 30 (30% soluble insulin aspart, 70% protamine-crystallized insulin aspart) (NovoMix®)30) in type 2 diabetes patients in routine clinical practice in Iran.


METHODS
IMPROVE™ was a 26-week, multinational, open-label, non-randomized study in patients with type 2 diabetes. The safety and efficacy of BIAsp 30 were assessed at baseline and at 13 and 26 weeks. The titration of BIAsp30 was at the physician's discretion.


RESULTS
In Iran, 478 patients (47% male) previously treated with oral antidiabetic drugs (OADs) (N = 159, 33.3%) and/or insulin other than BIAsp30 (N = 317, 66.3%) or a few who were treatment-naïve (N = 2, 0.4%) participated in the study. After 26 weeks of treatment with BIAsp 30, the rate of reported major hypoglycaemic episodes was reduced by 88.1% from baseline (baseline v. Week 26: 0.303 v. 0.037 episodes/pt-year; p < 0.001). No significant differences in minor hypoglycaemic episodes between baseline and Week 26 were found. Glycaemic control was significantly improved from baseline to Week 26 with a mean HbA(₁c) reduction of 1.2 +/- 1.9%. Patients' quality of life as measured by the DiabMedSat questionnaire significantly improved from baseline (58.1) to the end of the study (75.4, p < 0.001).


CONCLUSIONS
BIAsp 30 therapy appeared safe and effective and improved quality of life in Iranian patients with type 2 diabetes after 26 weeks of treatment.
Esteghamati
Alireza
A
Imam Khomeini Hospital, Endocrine and Metabolism research Department, Tehran, Iran.
Rajabian
Reza
R
Amini
Masoud
M
Bahrami
Amir
A
Khamseh
Mohammad Ebrahim
ME
Afkhami-Ardekani
Mohammad
M
Rizi
Ehsan Parvaresh
EP
D061265:Biphasic Insulins; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D061267:Insulin Aspart; D007336:Insulin, Isophane; D007492:Iran / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life
D061265:Biphasic Insulins; D007004:Hypoglycemic Agents; D007328:Insulin; C557564:insulin aspart, insulin aspart protamine drug combination 30:70; D007336:Insulin, Isophane; D061267:Insulin Aspart