Different Insulin Regimens and Postprandial Coagulation Activation

This study has been completed.
Sponsor:
Collaborators:
Ribe County Hospital
Novo Nordisk A/S
Information provided by:
Hospital of South West Denmark
ClinicalTrials.gov Identifier:
NCT01053234
First received: January 20, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention
Type 2 Diabetes
Cardiovascular Risk
Hemostasis
Inflammation
Endothelial Function
Dietary Supplement: Standardised meals

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hospital of South West Denmark:

Primary Outcome Measures:
  • Prothrombin fragment 1+2 [ Time Frame: 7.40; 9.30; 11.30; 13.30; 15.30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • C-reactive protein [ Time Frame: 7.40; 9.30; 11.30; 13.30; 15.30 ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: February 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin aspart Dietary Supplement: Standardised meals
Experimental: NPH insulin Dietary Supplement: Standardised meals

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053234

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

No publications provided

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
Study First Received: January 20, 2010
Last Updated: January 20, 2010
Health Authority: Denmark: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 21, 2014