Different Insulin Regimens and Postprandial Coagulation Activation

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)

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78 participants in 2 patient groups

Insulin aspart

Experimental group

Treatment:

Dietary Supplement: Standardised meals

NPH insulin

Experimental group

Treatment:

Dietary Supplement: Standardised meals