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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01053234

Enrollment

Registered

2010-01-21

Start date

2007-02-28

Completion date

2007-05-31

Last updated

2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk, Endothelial Function, Hemostasis, Inflammation, Type 2 Diabetes

Keywords

Hyperglycaemia, Postprandial, Type 2 diabetes, Cardiovascular risk markers

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.

Interventions

DIETARY_SUPPLEMENTStandardised meals

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Prothrombin fragment 1+2	7.40; 9.30; 11.30; 13.30; 15.30

Secondary

Measure	Time frame
C-reactive protein	7.40; 9.30; 11.30; 13.30; 15.30

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026