Clinical trial NCT01293396: Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids
Official title: Comparison of the Impact of Biphasic Insulin Aspart 30 (BiAsp 30), Biphasic Insulin Aspart 70 (BiAsp 70) and Insulin Aspart on Postprandial Glucose and Lipid Metabolism During Two Consecutive Meals in Type 2 Diabetics.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: insulin aspart 30
insulin aspart 70
insulin aspart
postprandial glucose and lipid metabolism
consecutive mixed meals
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 (remixed Insulin Aspart 30, Aspart 70 and Aspart) have been shown before, their specific glucose and lipid lowering capacities have so far not been investigated in a simulated physiological situation.

Eligibility 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
* Alaninaminotranferase or Aspartataminotransferase \> 3x Upper Limit of Normal
* 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

Primary outcomes:
measure: Area Over Basal for Postprandial Glucose From 0 to 600min
timeFrame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
measure: Area Over Basal for Postprandial Triglycerides
timeFrame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Secondary outcomes:
measure: Maximum Glucose Increase
timeFrame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
measure: Maximum Triglyceride Increase
timeFrame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
measure: Area Over Basal for Postprandial Insulin
timeFrame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
measure: Area Over Basal for Postprandial C-peptide
timeFrame: 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Department for Internal Medicine
Study officials:
affiliation: Medical University of Graz, 8036 Graz, Austria
name: Harald Sourij, MD
role: PRINCIPAL_INVESTIGATOR
References: