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Completed

NCT Number: NCT01293396

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Graz, Department for Internal Medicine

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin aspart

Drug

Patients received insulin aspart before breakfast and before lunch.

Other names: Novorapid

Insulin Aspart 30

Drug

Patients received biphasic insulin aspart 30 before breakfast and before lunch.

Other names: Novomix 30

Insulin Aspart 70

Drug

Patients received biphasic insulin aspart 70 before breakfast and before lunch.

Other names: Novomix 70

Primary outcomes

  1. Area Over Basal for Postprandial Glucose From 0 to 600min

    Time frame: 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.

  2. Area Over Basal for Postprandial Triglycerides

    Time frame: 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 outcomes

  1. Maximum Glucose Increase

    Time frame: 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

  2. Maximum Triglyceride Increase

    Time frame: 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

  3. Area Over Basal for Postprandial Insulin

    Time frame: 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.

  4. Area Over Basal for Postprandial C-peptide

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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.

Acronym: HUCKEPACK2

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2011
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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