INSUlin Regimens and VASCular Functions

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The aim of this pilot study is, in type 2 diabetic patients now requiring insulin, to compare the effects of improving glycemic control on these parameters with 3 different insulin regimens which will act especially at fasting or in post-prandial periods or both. Non invasive explorations will be performed before randomization and after 4 to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Insulin; Insulin Aspart; Insulin Detemir; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Consent patient

• Adults from 30 to 72 years old

• type 2 diabetic patients for at least 1 year

• able to self measure capillary blood glucose

• body mass index 20-37 kg/m²,

• HbA1c 7.1-12% under Metformin and SULFUNYREAS therapy for at least 2 months

• anti-hypertensive treatment or dyslipidemic treatment unchanged for 3 months

Exclusion criteria:

• pregnancy

• other antidiabetic medication in the previous 2 months,

• anti-hypertensive or lipid-lowering therapies having been changed in the previous 2 months,

• insulin allergy,

• uncontrolled preproliferative or proliferative diabetic retinopathy

• uncontrolled hypertension

• renal failure(creatinin clearance <40 ml/min)

• hepatocellular deficiency (prothrombin time <70%)

• anemia

• peripheral occlusive arterial disease

• cardiac arrhythmia