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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ 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 ]

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 ] [ 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 ]

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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01293396     History of Changes
Other Study ID Numbers: ENM-DA-008, 2008-008486-35
Study First Received: February 9, 2011
Last Updated: September 22, 2011
Health Authority: Austria: Ethikkommission

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:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013