Clinical trial NCT01039532: Comparison of Thrice Daily Biphasic Human Insulin With Basal Bolus Regimen in Type 2 Diabetes Mellitus Patients
Official title: Comparison of Thrice Daily Biphasic Human Insulin Versus Basal Detemir and Bolus Aspart in Patients With Poorly Controlled Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes mellitus
Biphasic human insulin thrice a day
Basal bolus insulin
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2009-12-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 type 2 diabetes mellitus patients inadequately controlled patients treated with human premixed insulin twice daily for at least 3months along with metformin 2g/d and pioglitazone 30mg/d.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycaemic control
timeFrame: 3months
Secondary outcomes:
measure: Weight gain Hypoglycaemic episodes Adverse effects Cost effectiveness
timeFrame: 3 months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: AnilBhansali
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Anil Bhansali, DM
role: PRINCIPAL_INVESTIGATOR
References: