Different Insulin Regimens and Postprandial Coagulation Activation
NCT ID: NCT01053234
Last Updated: 2022-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2007-02-28
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin aspart
Standardised meals
NPH insulin
Standardised meals
Interventions
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Standardised meals
Eligibility Criteria
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Inclusion Criteria
* BMI \> 25 kg/m2
* type 2 diabetes for more than 4 years
* pharmacological anti-diabetic treatment with insulin NPH at bedtime or insulin aspart at meals for more than 24 months
* metformin with stable dose \>1000 mg/d for more than 12 weeks
* acetylsalicylic acid (75 mg/d) for more than 2 weeks
* no other anti-diabetic treatment 3 month previously
* HbA1c\<8.5% at recruitment.
Exclusion Criteria
* ALAT /ASAT \> 2.5 x upper reference limit
* use of anticoagulants within 1 month previously
* any changes in dose of statins within 1 month previously
* night work
* present or planned pregnancy
* mental sickness or alcohol abuse
* clinically relevant major organ or systemic illness
* uncontrolled hypertension \>180/110 mmHg
* steroid treatment
* known or suspected allergy to trial medications.
30 Years
75 Years
ALL
No
Sponsors
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Ribe County Hospital
OTHER
Novo Nordisk A/S
INDUSTRY
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Responsible Party
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Department of Medicine, Hospital of South West Denmark
Principal Investigators
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Jeppe Gram, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, Hospital of South West Denmark
Locations
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Hospital of South West Denmark
Esbjerg, , Denmark
Countries
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Other Identifiers
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RRS 2006-1032
Identifier Type: -
Identifier Source: org_study_id
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