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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293396
First Posted: February 10, 2011
Last Update Posted: September 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medical University of Graz
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Drug: Insulin Aspart Drug: Insulin Aspart 30 Drug: Insulin Aspart 70 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Biphasic Insulin Aspart 30 Drug: Insulin Aspart 30
Patients received biphasic insulin aspart 30 before breakfast and before lunch.
Other Name: Novomix 30
Active Comparator: Biphasic Insulin Aspart 70 Drug: Insulin Aspart 70
Patients received biphasic insulin aspart 70 before breakfast and before lunch.
Other Name: Novomix 70
Active Comparator: Insulin Aspart Drug: Insulin Aspart
Patients received insulin aspart before breakfast and before lunch.
Other Name: Novorapid

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.
  Eligibility

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293396


Locations
Austria
Medical University of Graz, Department for Internal Medicine
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
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
  More Information

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01293396     History of Changes
Other Study ID Numbers: ENM-DA-008
2008-008486-35 ( EudraCT Number )
First Submitted: February 9, 2011
First Posted: February 10, 2011
Last Update Posted: September 23, 2011
Last Verified: September 2011

Keywords provided by Medical University of Graz:
insulin aspart 30
insulin aspart 70
insulin aspart
postprandial glucose and lipid metabolism
consecutive mixed meals

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs


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