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

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

Completed

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AnilBhansali

Chandigarh, 160012, India

About this study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Glycaemic control

Time frame: 3months

Secondary outcomes

Weight gain Hypoglycaemic episodes Adverse effects Cost effectiveness

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Dec 25, 2009
Registry last updated: Oct 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed