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

Study Overview
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Brief Summary
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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. Basal detemir + bolus aspart or 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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basal Bolus regimen<br>Basal Bolus regimen | |
| Biphasic human insulin<br>Biphasic human insulin | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control |  | 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain Hypoglycaemic episodes Adverse effects Cost effectiveness |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Biphasic human insulin thrice a day, Basal bolus insulin