Different Insulin Regimens and Postprandial Coagulation Activation
Effects of Standardised Meals on Postprandial Coagulation Activation in Patients With Type 2 Diabetes Treated With Two Different Insulin Regimens
1 other identifier
interventional
78
1 country
1
Brief Summary
The purpose of this study in patients with type 2 diabetes was to investigate the acute effect of postprandial blood glucose levels modified by two different insulin treatment regimens on coagulation activation, inflammation and endothelial cell function. The investigators hypothesized that the rapid-acting insulin analogue aspart has a beneficial postprandial effect on coagulation, endothelial dysfunction and inflammation compared with the intermediate-acting insulin NPH due to its ability to lower postprandial glycaemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Feb 2007
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 20, 2010
CompletedFirst Posted
Study publicly available on registry
January 21, 2010
CompletedOctober 19, 2022
October 1, 2022
3 months
January 20, 2010
October 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prothrombin fragment 1+2
7.40; 9.30; 11.30; 13.30; 15.30
Secondary Outcomes (1)
C-reactive protein
7.40; 9.30; 11.30; 13.30; 15.30
Study Arms (2)
Insulin aspart
EXPERIMENTALNPH insulin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- age 30-75 years
- 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.
You may not qualify if:
- creatinine \> 120 µmol/l
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Esbjerg Hospital - University Hospital of Southern Denmarklead
- Ribe County Hospitalcollaborator
- Novo Nordisk A/Scollaborator
Study Sites (1)
Hospital of South West Denmark
Esbjerg, 6700, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeppe Gram, Ph.D
Department of Medicine, Hospital of South West Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 20, 2010
First Posted
January 21, 2010
Study Start
February 1, 2007
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
October 19, 2022
Record last verified: 2022-10