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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anil Bhansali, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01039532
First received: December 24, 2009
Last updated: October 23, 2015
Last verified: October 2015

December 24, 2009
October 23, 2015
July 2008
January 2010   (final data collection date for primary outcome measure)
Glycaemic control [ Time Frame: 3months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01039532 on ClinicalTrials.gov Archive Site
Weight gain Hypoglycaemic episodes Adverse effects Cost effectiveness [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparison of Thrice Daily Biphasic Human Insulin With Basal Bolus Regimen in Type 2 Diabetes Mellitus Patients
Comparison of Thrice Daily Biphasic Human Insulin Versus Basal Detemir and Bolus Aspart in Patients With Poorly Controlled Type 2 Diabetes Mellitus

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

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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.
Diabetes Mellitus, Type 2
Not Provided
  • Basal Bolus regimen
    Basal Bolus regimen
  • Biphasic human insulin
    Biphasic human insulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01039532
BHI3
Yes
Not Provided
Not Provided
Anil Bhansali, Postgraduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research
Not Provided
Principal Investigator: Anil Bhansali, DM Postgraduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP