Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids
- Conditions
- Type 2 Diabetes
- Interventions
- Registration Number
- NCT01293396
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Biphasic Insulin Aspart 70 Insulin Aspart 70 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch Biphasic Insulin Aspart 30 Insulin Aspart 30 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch Insulin Aspart Insulin Aspart 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch
- Primary Outcome Measures
Name Time Method Area Over Basal for Postprandial Glucose From 0 to 600min 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) Area over basal for postprandial glucose from 0 (Fasting glucose, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Area Over Basal for Postprandial Triglycerides 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) Area over basal for postprandial triglycerides from 0 (Fasting triglycerides, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
- Secondary Outcome Measures
Name Time Method Area Over Basal for Postprandial Insulin 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) Area over basal for postprandial insulin from 0 (Fasting insulin, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Maximum Glucose Increase 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) Maximum glucose increase from baseline to 600min after baseline
Maximum Triglyceride Increase 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) Maximum trigylceride increase from Baseline to 600min after Baseline
Area Over Basal for Postprandial C-peptide 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) Area over basal for postprandial c-peptide from 0 (Fasting c-peptide, measured at daily study start) to 600 min (after breakfast) Area over basal is calculated according to the trapezoidal rule.
Trial Locations
- Locations (1)
Medical University of Graz, Department for Internal Medicine
🇦🇹Graz, Austria