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

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Other

Identifiers

NCT01039532

BHI3

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 Diabetics >/= 18 yrs of age Diabetic for >/= 6months

• Inadequately controlled patients treated with human premixed insulin twice daily for at least 3months along with metformin 2g/d and pio30mg/d

  • Single dose of insulin exceeding 25 units or total insulin dose is more than 0.7u/kg/day with
  • If post lunch blood glucose is not controlled
  • If HbA1c ≥7%

• No major cardiac events in the preceding 6 months.

• NYHA <= Class II.

Exclusion criteria

• Deranged LFT's- AST,ALT or ALP values >= 2 times.
• Deranged RFT Sr. Creatinine >=1.5
• Allergy to Insulin or its products.
• Recent intake of any new medications for sugar control.
• Illiterate to the level that she/he cannot understand the study.
• Any other acute co morbid illness.
• Pregnancy.
• Decompensated heart failure/UsA/MI all within last 12month
• Untreated proliferative retinopathy/ maculopathy
• Drug or alcohol dependence

Trial design

50 participants in 2 patient groups

Basal Bolus regimen

Description:

Basal Bolus regimen

Biphasic human insulin

Description:

Biphasic human insulin