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Different Insulin Regimens and Postprandial Coagulation Activation

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ClinicalTrials.gov Identifier: NCT01053234
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : January 21, 2010
Ribe County Hospital
Novo Nordisk A/S
Information provided by:
Hospital of South West Denmark

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.

Condition or disease Intervention/treatment
Type 2 Diabetes Cardiovascular Risk Hemostasis Inflammation Endothelial Function Dietary Supplement: Standardised meals

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Standardised Meals on Postprandial Coagulation Activation in Patients With Type 2 Diabetes Treated With Two Different Insulin Regimens
Study Start Date : February 2007
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Insulin aspart Dietary Supplement: Standardised meals
Experimental: NPH insulin Dietary Supplement: Standardised meals

Primary Outcome Measures :
  1. Prothrombin fragment 1+2 [ Time Frame: 7.40; 9.30; 11.30; 13.30; 15.30 ]

Secondary Outcome Measures :
  1. C-reactive protein [ Time Frame: 7.40; 9.30; 11.30; 13.30; 15.30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053234

Hospital of South West Denmark
Esbjerg, Denmark, 6700
Sponsors and Collaborators
Hospital of South West Denmark
Ribe County Hospital
Novo Nordisk A/S
Principal Investigator: Jeppe Gram, Ph.D Department of Medicine, Hospital of South West Denmark

Responsible Party: Chief physician, Ph.D Jeppe Gram, Department of Medicine, Hospital of South West Denmark
ClinicalTrials.gov Identifier: NCT01053234     History of Changes
Other Study ID Numbers: RRS 2006-1032
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: January 21, 2010
Last Verified: January 2010

Keywords provided by Hospital of South West Denmark:
Type 2 diabetes
Cardiovascular risk markers

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs