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

Condition(s) targeted: Type 2 Diabetes

Intervention: Insulin Aspart (Drug); Insulin Aspart 30 (Drug); Insulin Aspart 70 (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Medical University of Graz

Official(s) and/or principal investigator(s):
Thomas R Pieber, MD, Prof., Principal Investigator, Affiliation: Medical University of Graz, Dept. of Internal Medicine, Div. of Endocrinology and Metabolism, Auenbruggerpl. 15, 8036 Graz, Austria

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.

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Area over basal for postprandial glucose at each meal alone and in combination

Area over basal for postprandial triglycerides and free fatty acids at each meal alone and in combination

Secondary outcome:

maximum glucose increase at each meal alone and in combination

maximum triglyceride increase at each meal alone and in combination

Area over basal for postprandial insulin at each meal alone and in combination

Area over basal for postprandial c-peptide at each meal alone and in combination

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.

Minimum age: 35 Years. Maximum age: 75 Years. Gender(s): Both.

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

Medical University of Graz, Department for Internal Medicine, Graz 8036, Austria

Starting date: June 2010
Last updated: September 22, 2011