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

P

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Study type

Observational

Funder types

Other

Identifiers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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