Comparison of Thrice Daily Biphasic Human Insulin With Basal Bolus Regimen in Type 2 Diabetes Mellitus Patients
Recruitment status was Active, not recruiting
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.
- Basal detemir + bolus aspart or
- Thrice Daily Biphasic Human Insulin Regimen.
The two regimens were compared by the following variables:
Weight gain, Hypoglycaemic episodes, Adverse effects and Cost effectiveness
Diabetes Mellitus, Type 2 [C19.246.300]
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Comparison of Thrice Daily Biphasic Human Insulin Versus Basal Detemir and Bolus Aspart in Patients With Poorly Controlled Type 2 Diabetes Mellitus|
- Glycaemic control [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
- Weight gain Hypoglycaemic episodes Adverse effects Cost effectiveness [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||January 2010|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
|Basal Bolus regimen|
|Biphasic human insulin|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039532
|Chandigarh, India, 160012|
|Principal Investigator:||Anil Bhansali, DM||Postgraduate Institute of Medical Education and Research|