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Completed

NCT Number: NCT01053234

Different Insulin Regimens and Postprandial Coagulation Activation

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.

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Key information

Conditions

Type 2 Diabetes Cardiovascular Risk Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Endothelial Function Glucose Metabolism Disorders Hemostasis Hyperglycemia Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of South West Denmark

Esbjerg, 6700, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standardised meals

Dietary Supplement

Primary outcomes

  1. Prothrombin fragment 1+2

    Time frame: 7.40; 9.30; 11.30; 13.30; 15.30

Secondary outcomes

  1. C-reactive protein

    Time frame: 7.40; 9.30; 11.30; 13.30; 15.30

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • Novo Nordisk A/S
  • Ribe County Hospital

Registry information

Official study title

Effects of Standardised Meals on Postprandial Coagulation Activation in Patients With Type 2 Diabetes Treated With Two Different Insulin Regimens

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 21, 2010
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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