NCT01039532

Comparison of Thrice Daily Biphasic Human Insulin With Basal Bolus Regimen in Type 2 Diabetes Mellitus Patients

Comparison of Thrice Daily Biphasic Human Insulin Versus Basal Detemir and Bolus Aspart in Patients With Poorly Controlled Type 2 Diabetes Mellitus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 2

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-12-25
• Last updated: 2015-10-26

Locations

1 site across 1 country: India