Different Insulin Regimens and Postprandial Coagulation Activation

NCT ID: NCT01053234

Last Updated: 2022-10-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemostasis Inflammation Endothelial Function Type 2 Diabetes Cardiovascular Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin aspart

Group Type EXPERIMENTAL

Standardised meals

Intervention Type DIETARY_SUPPLEMENT

NPH insulin

Group Type EXPERIMENTAL

Standardised meals

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Standardised meals

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ribe County Hospital

OTHER

Sponsor Role collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role lead

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

Site Status

Countries

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Denmark

Other Identifiers

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RRS 2006-1032

Identifier Type: -

Identifier Source: org_study_id

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