Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes mellitus, Biphasic human insulin thrice a day, Basal bolus insulin
Brief 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.
Interventions
None listed
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycaemic control | 3months |
Secondary
| Measure | Time frame |
|---|---|
| Weight gain Hypoglycaemic episodes Adverse effects Cost effectiveness | 3 months |
Countries
India
Outcome results
None listed