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

Type 2 Diabetes Clinical Trial

— HUCKEPACK2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293396
• Other study ID #: ENM-DA-008
• Secondary ID: 2008-008486-35
• Status: Completed
• Phase: Phase 4
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2021
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• Insulin Aspart
Patients received insulin aspart before breakfast and before lunch.
• Insulin Aspart 30
Patients received biphasic insulin aspart 30 before breakfast and before lunch.
• Insulin Aspart 70
Patients received biphasic insulin aspart 70 before breakfast and before lunch.

Locations

Country	Name	City	State
Austria	Medical University of Graz, Department for Internal Medicine	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)