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

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ClinicalTrials.gov Identifier: NCT01293396
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : September 23, 2011
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Tracking Information
First Submitted Date  ICMJE February 9, 2011
First Posted Date  ICMJE February 10, 2011
Last Update Posted Date September 23, 2011
Study Start Date  ICMJE June 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2011)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2011)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: February 9, 2011)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01293396
Other Study ID Numbers  ICMJE ENM-DA-008
2008-008486-35 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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