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
  Purpose

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


Condition
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Thrice Daily Biphasic Human Insulin Versus Basal Detemir and Bolus Aspart in Patients With Poorly Controlled Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Glycaemic control [ Time Frame: 3months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Weight gain Hypoglycaemic episodes Adverse effects Cost effectiveness [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: July 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Basal Bolus regimen
Basal Bolus regimen
Biphasic human insulin
Biphasic human insulin

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039532

Locations
India
AnilBhansali
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Anil Bhansali, DM Postgraduate Institute of Medical Education and Research
  More Information

Responsible Party: Anil Bhansali, prof and head, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01039532     History of Changes
Other Study ID Numbers: BHI3 
Study First Received: December 24, 2009
Last Updated: October 23, 2015
Health Authority: India: Institutional Review Board

Keywords provided by Postgraduate Institute of Medical Education and Research:
Type 2 diabetes mellitus
Biphasic human insulin thrice a day
Basal bolus insulin

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2016