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Different Insulin Regimens and Postprandial Coagulation Activation

M

Modulex

Status

Completed

Conditions

Endothelial Function
Hemostasis
Inflammation
Cardiovascular Risk
Type 2 Diabetes

Treatments

Dietary Supplement: Standardised meals

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01053234
RRS 2006-1032

Details and patient eligibility

About

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.

Enrollment

78 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

78 participants in 2 patient groups

Insulin aspart
Experimental group
Treatment:
Dietary Supplement: Standardised meals
NPH insulin
Experimental group
Treatment:
Dietary Supplement: Standardised meals

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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