Designer insulins regimens in clinical practice--pilot multicenter Indian study.
BACKGROUND
Newer insulin analogues viz., premix insulin analogue (biphasic insulin aspart) and insulin glargine are now available in India. A multicenter all-India study was done to document the patient profile and responses to these analogues in routine clinical practice.


METHODS
The study was conducted prospectively at 4 diabetes care clinics in different regions of India and collected data on the use of either of the two regimens A. Premix insulin analogue given twice-daily B. Basal-bolus analogue regimen (insulin aspart with every meal and insulin glargine once-a-day at bedtime). The centers collected all data at 3 time-points--baseline, 4 weeks later and end of 12 weeks. The study measures were FPG (fasting plasma glucose), PPPG (postprandial plasma glucose), HbA1c and insulin dose. FPG and PPPG were recorded at each of the three time points. HbA1c was recorded at baseline and end of study. Safety was assessed based on reported adverse drug reactions and occurrence of hypoglycaemias.


RESULTS
Data of 145 patients was available for analysis (n=114 on premix insulin analogue and n=31 on basal-bolus analogue regimen). Baseline demography was comparable in the two groups. Both the regimens lowered all blood glucose parameters including HbA1c significantly as compared to baseline. However, the premix insulin analogue fared better than the basal-bolus regimen in lowering HbA1c (1.58 vs. 1.16% respectively; p<0.05). Also 41% more patients in the premix group could achieve target HbA1c of < 7% at the end of study. The mean insulin dose was lower with the premix analogue group at the end of 12 weeks. There was no significant difference between the two groups in terms of change in body weight. No major hypoglycaemias were reported and the percentage of patients experiencing a minor episode was lower with the premix analogue than the basal-bolus regimen both at 4 and 12 weeks (11.4 vs. 35.48%; 16.7 vs. 58.06% respectively). No adverse drug reactions were reported throughout the study.


CONCLUSIONS
We conclude that both premix analogue administered twice a day and four times a day basal bolus regimen appear to be a convenient, safe and effective way of initiating insulin therapy in people with type-2 diabetes. The premix analogues achieves target better than the basal bolus regimen as has better compliance.
Joshi
S R
SR
Dept of Medicine and Endocrinology, Grant Medical College and Sir JJ Groups of Hospital, Mumbai.
Kalra
S
S
Badgandi
M
M
Rao
Y S
YS
Chawla
M
M
D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D015195:Drug Design; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis / Q000187:drug effects; D006801:Humans; D007194:India; D007328:Insulin / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D016896:Treatment Outcome
D006442:Glycated Hemoglobin; D007328:Insulin