Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids (HUCKEPACK2)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Medical University of Graz

ClinicalTrials.gov Identifier:

NCT01293396

First received: February 9, 2011

Last updated: September 22, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 9, 2011

Last Updated Date

September 22, 2011

Start Date ^ICMJE

June 2010

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Area over basal for postprandial glucose at each meal alone and in combination [ Time Frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 min ] [ Designated as safety issue: No ]
Area over basal for postprandial triglycerides and free fatty acids at each meal alone and in combination [ Time Frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 min ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01293396 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

maximum glucose increase at each meal alone and in combination [ Time Frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 min ] [ Designated as safety issue: No ]
maximum triglyceride increase at each meal alone and in combination [ Time Frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 min ] [ Designated as safety issue: No ]
Area over basal for postprandial insulin at each meal alone and in combination [ Time Frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 min ] [ Designated as safety issue: No ]
Area over basal for postprandial c-peptide at each meal alone and in combination [ Time Frame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 min ] [ Designated as safety issue: No ]

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 Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids

Official Title ^ICMJE

Comparison of the Impact of Biphasic Insulin Aspart 30(BiAsp30), Biphasic Insulin Aspart 70 (BiAsp 70) and Insulin Aspart on Postprandial Glucose and Lipid Metabolism During Two Consecutive Meals in Type 2 Diabetics.

Brief Summary

The aim of the study is to investigate meal-related treatment with either premixed Insulin Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free fatty acids excursions after a standard breakfast and lunch.

Detailed Description

Whereas the effects of each of the established types of insulin (BiAsp30, BiAsp70, Insulin Aspart) have been shown before, their specific glucose and lipid lowering capacities have so far not been investigated in a simulated physiological situation.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Drug: Insulin Aspart
Patients received insulin aspart before breakfast and before lunch.

Other Name: Novorapid
Drug: Insulin Aspart 30
Patients received biphasic insulin aspart 30 before breakfast and before lunch.

Other Name: Novomix 30
Drug: Insulin Aspart 70
Patients received biphasic insulin aspart 70 before breakfast and before lunch.

Other Name: Novomix 70

Study Arm (s)

Active Comparator: Biphasic Insulin Aspart 30
Intervention: Drug: Insulin Aspart 30
Active Comparator: Biphasic Insulin Aspart 70
Intervention: Drug: Insulin Aspart 70
Active Comparator: Insulin Aspart
Intervention: Drug: Insulin Aspart

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

Completed

Enrollment ^ICMJE

Completion Date

March 2011

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type-II Diabetes
BMI > 27 kg/m2
age 35 to 75 years
HbA1c < 8.5%
informed consent
treatment with pre-mixed insulin
stabile dose of insulin for at least 4 weeks

Exclusion Criteria:

Type-I Diabetes mellitus
HbA1c > 8.5 %
Serum Creatinine > 1.7 mg/dl
ALT or AST > 3x ULN
treatment with sulfonylurea or gliptins
treatment with glitazones
manifest clinical infections
treatment with glucocorticoids or antipsychotic drugs
psychiatric diseases
alcohol abuse
myocardial infarction or stroke within the previous 3 months
surgery within the previous 3 months

Gender

Both

Ages

35 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT01293396

Other Study ID Numbers ^ICMJE

ENM-DA-008, 2008-008486-35

Has Data Monitoring Committee

Responsible Party

Medical University of Graz

Study Sponsor ^ICMJE

Medical University of Graz

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thomas R Pieber, MD, Prof.

Medical University of Graz, Dept. of Internal Medicine, Div. of Endocrinology and Metabolism, Auenbruggerpl. 15, 8036 Graz, Austria

Information Provided By

Medical University of Graz

Verification Date

September 2011

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

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