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

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Insulin Aspart 30; Drug: Insulin Aspart 70; Drug: Insulin Aspart

Study type: Interventional

Funder types: Other

Identifiers

NCT01293396

2008-008486-35 (EudraCT Number)

ENM-DA-008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Biphasic Insulin Aspart 30

Active Comparator group

Description:

35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

Treatment:

Drug: Insulin Aspart 30

Biphasic Insulin Aspart 70

Active Comparator group

Description:

35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

Treatment:

Drug: Insulin Aspart 70

Insulin Aspart

Active Comparator group

Description:

35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

Treatment:

Drug: Insulin Aspart