Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT01039532
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
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:
NCT01039532
Study Brief:
Protocol Section:
NCT01039532