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

NCT ID: NCT01293396

Last Updated: 2021-06-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-03-31

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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biphasic Insulin Aspart 30

35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

Group Type ACTIVE_COMPARATOR

Insulin Aspart 30

Intervention Type DRUG

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

Biphasic Insulin Aspart 70

35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

Group Type ACTIVE_COMPARATOR

Insulin Aspart 70

Intervention Type DRUG

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

Insulin Aspart

35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch

Group Type ACTIVE_COMPARATOR

Insulin Aspart

Intervention Type DRUG

Patients received insulin aspart before breakfast and before lunch.

Interventions

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Insulin Aspart

Patients received insulin aspart before breakfast and before lunch.

Intervention Type DRUG

Insulin Aspart 30

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

Intervention Type DRUG

Insulin Aspart 70

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

Intervention Type DRUG

Other Intervention Names

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Novorapid Novomix 30 Novomix 70

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harald Sourij, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, 8036 Graz, Austria

Locations

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Medical University of Graz, Department for Internal Medicine

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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2008-008486-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ENM-DA-008

Identifier Type: -

Identifier Source: org_study_id

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