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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

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Insulin Aspart Drug: Insulin Aspart 30 Drug: Insulin Aspart 70 Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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.
Study Start Date : June 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
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

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

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 Posted: February 10, 2011    Key Record Dates
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