Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Comparison of Thrice Daily Biphasic Human Insulin Versus Basal Detemir and Bolus Aspart in Patients With Poorly Controlled Type 2 Diabetes Mellitus
It is a proven fact that Basal Bolus insulin regimen is the near- physiological regimen &
Thrice daily Biphasic Insulin Aspart is a comparable alternative for glycemic control in
type 2 diabetes mellitus patients. In this study the investigators evaluated whether
Biphasic Human Insulin can be used in a thrice daily regimen in place of BIAsp.
As the regimen is less expensive and one prick less than the basal-bolus regimen, it can be
a good alternative for a diabetics in India.
This is a 12 week Open labelled parallel-Randomised controlled pilot study - 50 patients
with type 2 Diabetes mellitus was selected after satisfying the inclusion and exclusion
criteria's .Metformin and pioglitazone were continued and they are randomised into 2 groups
at base line and was allotted into any of the two regimens.
1. Basal detemir + bolus aspart or
2. Thrice Daily Biphasic Human Insulin Regimen.
The two regimens were compared by the following variables:
Primary endpoint:
Glycaemic control
Secondary endpoint:
Weight gain, Hypoglycaemic episodes, Adverse effects and Cost effectiveness
It is a proven fact that Basal Bolus insulin regimen is the near- physiological regimen & Thrice daily Biphasic Insulin Aspart is a comparable alternative for glycemic control in type 2 diabetes mellitus patients. In this study the investigators evaluated whether Biphasic Human Insulin can be used in a thrice daily regimen in place of BIAsp. ;
Observational Model: Case Control, Time Perspective: Prospective
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