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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2008 by Postgraduate Institute of Medical Education and Research.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Postgraduate Institute of Medical Education and Research

ClinicalTrials.gov Identifier:

NCT01039532

First received: December 24, 2009

Last updated: NA

Last verified: July 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

December 24, 2009

Last Updated Date

December 24, 2009

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Glycaemic control [ Time Frame: 3months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Diabetes Mellitus, Type 2 [C19.246.300]

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Basal Bolus regimen
Biphasic human insulin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

January 2010

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT01039532

Other Study ID Numbers ^ICMJE

BHI3

Has Data Monitoring Committee

Yes

Responsible Party

Dr Anil Bhansali, Postgraduate Institute of Medical Education and Research

Study Sponsor ^ICMJE

Postgraduate Institute of Medical Education and Research

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Anil Bhansali, DM

Postgraduate Institute of Medical Education and Research

Information Provided By

Postgraduate Institute of Medical Education and Research

Verification Date

July 2008

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

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