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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Insulin Aspart
* Drug: Insulin Aspart 30
* Drug: Insulin Aspart 70


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Biphasic Insulin Aspart 30<br>35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch | Drug: Insulin Aspart 30<br>* Patients received biphasic insulin aspart 30 before breakfast and before lunch.<br>* Other names: Novomix 30;|
| Active Comparator: Biphasic Insulin Aspart 70<br>35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch | Drug: Insulin Aspart 70<br>* Patients received biphasic insulin aspart 70 before breakfast and before lunch.<br>* Other names: Novomix 70;|
| Active Comparator: Insulin Aspart<br>35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch | Drug: Insulin Aspart<br>* Patients received insulin aspart before breakfast and before lunch.<br>* Other names: Novorapid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Over Basal for Postprandial Glucose From 0 to 600min | 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. | 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 | 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. | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Glucose Increase | Maximum glucose increase from baseline to 600min after baseline | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) | 
| Maximum Triglyceride Increase | Maximum trigylceride increase from Baseline to 600min after Baseline | 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 | 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. | 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 | 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. | 0,30,60,90,120,180,240,270,300,330,360,420,480,540,600 minutes post-dose (daily study start) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin aspart 30, insulin aspart 70, insulin aspart, postprandial glucose and lipid metabolism, consecutive mixed meals