Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-27 @ 2:49 AM
Study NCT ID:
NCT01039532
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2009-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Thrice Daily Biphasic Human Insulin With Basal Bolus Regimen in Type 2 Diabetes Mellitus Patients
Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Organization:
Study Overview
Official Title:
Comparison of Thrice Daily Biphasic Human Insulin Versus Basal Detemir and Bolus Aspart in Patients With Poorly Controlled Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: