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

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.

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Insulin Aspart 30; Drug: Insulin Aspart 70; Drug: Insulin Aspart

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Harald Sourij, MD, Medical University of Graz, 8036 Graz, Austria

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: insulin aspart; insulin aspart 30; insulin aspart 70; postprandial glucose and lipid metabolism; consecutive mixed meals
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin aspart, insulin aspart protamine drug combination 30:70
• Other Study ID Numbers: ENM-DA-008; 2008-008486-35 (EudraCT Number)