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

February 9, 2011
September 22, 2011
June 2010
February 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01293396 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
March 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01293396
ENM-DA-008, 2008-008486-35
No
Medical University of Graz
Medical University of Graz
Not Provided
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
Medical University of Graz
September 2011

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