Baseline characteristics of the Indian cohort from the IMPROVE study: a multinational, observational study of biphasic insulin aspart 30 treatment for type 2 diabetes.
BACKGROUND
The IMPROVE study is an openlabel, nonrandomized, observational study aimed at determining the safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) treatment in subjects with type 2 diabetes from 11 countries. Here, we report the baseline data of the Indian cohort.


METHODS
All subjects with type 2 diabetes requiring insulin and considered suitable for BIAsp 30 therapy based on their physician's clinical judgment were eligible to enter the study. The data recorded at baseline included demographic characteristics, detailed medical histories, physician-cited reasons for starting BIAsp 30 treatment, and the chosen dosage regimens.


RESULTS
The Indian cohort included 17,995 subjects with diabetes. Poor glycemic control (glycated hemoglobin [HbA(1c)], 8.7%-9.6%) was observed at baseline in all four geographical zones (North, South, East, and West) and prestudy treatment groups (no therapy, only oral antidiabetic drug [OAD], OAD +/- insulin, and OAD +/- insulin +/- BIAsp 30). Prevalence of both micro- and macrovascular complications was high, also reflecting poor glycemic control. Improving HbA(1c) and fasting and postprandial blood glucose levels were the most common reasons for starting BIAsp 30 therapy. The subjects were prescribed a mean BIAsp 30 dose of approximately 24 IU, and a twice-daily regimen was employed in almost 80% of subjects.


CONCLUSIONS
The baseline results of the IMPROVE study Indian cohort confirm the poor glycemic control and the delayed initiation and/or inadequacy of treatment in subjects with type 2 diabetes. These results also highlight the need for timely and appropriately intensive insulin-based therapy.
Shah
Siddharth
S
Department of Endocrinology, S. L. Raheja Hospital, Mumbai, India.
Das
A K
AK
Kumar
Ajay
A
Unnikrishnan
A G
AG
Kalra
Sanjay
S
Baruah
M P
MP
Ganapathi
B
B
Sahay
R K
RK
D000368:Aged; D061265:Biphasic Insulins; D001786:Blood Glucose / Q000187:drug effects; D015992:Body Mass Index; D015331:Cohort Studies; D003710:Demography; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D003925:Diabetic Angiopathies / Q000517:prevention & control*; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007194:India; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D061267:Insulin Aspart; D007336:Insulin, Isophane; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction
D061265:Biphasic Insulins; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061267:Insulin Aspart; D007336:Insulin, Isophane; C557564:insulin aspart, insulin aspart protamine drug combination 30:70