Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate the postprandial time course of
      nitrotyrosine after injection of insulin glulisine compared with regular human insulin.

      The secondary objectives are to evaluate the postprandial time course of the following
      efficacy parameters after injection of insulin glulisine compared with regular insulin on

        -  Blood Glucose

        -  Insulin

        -  Intact proinsulin

        -  Asymmetric dimethylarginine (ADMA)

        -  Metal matrix proteasis (MMP-9)

        -  Oxidative status (per ox)

        -  Interleukin 18 (IL-18)

        -  Free fatty acids (FFA)

        -  Oxidised LDL (ox-LDL)

        -  Microvascular blood circulation measured with laser Doppler at 37 °C (LDF37)

        -  Microvascular blood circulation measured with laser Doppler at 44 °C (LDF44)
    

Detailed description: 
      Phase III b Indication Type 2 Diabetes Trial Objectives 1) Primary objective: The primary
      objective of the study is to evaluate the postprandial time course of nitrotyrosine after
      injection of insulin glulisine compared with regular human insulin. 2) Secondary objectives:
      The secondary objectives are to evaluate the postprandial time course of blood glucose,
      insulin, intact proinsulin, asymmetric dimethylarginine (ADMA), metal matrix proteasis
      (MMP-9), free fatty acids (FFA), oxidised LDL (ox-LDL), oxidative status (per ox), IL-18 as
      well as postprandial time course of microvascular blood circulation measured with
      laserdopplerflux at 37 °C (LDF37) and 44 C (LDF44).

      Efficacy Variables Primary efficacy variablePostprandial time course of
      nitrotyrosineSecondary efficacy variablePostprandial time course of glucose, insulin, intact
      proinsulin, ADMA, MMP-9, FFA, ox-LDL, per-ox, and IL-18 as well as postprandial time course
      of laserdopplerflux at 37 °C and 44 °C Safety Variables Incidence and frequency of adverse
      events and evaluation of safety laboratory parameters Medication/Dosage Insulin glulisine,
      dose 0.10 U/kg and Regular Human Insulin, dose 0.10 U/kg Study Duration Duration of study
      participation for one patient: 5 - 43 days Overall duration of the study: 6 months Design
      Single-centre, open label, randomized, 2-way-crossover trial Population Male and female type
      2 diabetic patients between 40 and 70 years with HbA1c between 6.5 % and 9.9 % and treated
      with sulfonyurea alone or in combination with Metformin in a stable dosage within the last 3
      months Sample Size N = 15
    

Intervention name(s): Insulin Glulisine; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): 100 IU/ml, 0.10 U/kg immediately before ingestion of a standardised liquid meal; 100 IU/ml, 0.10 U/kg 15 Minutes before ingestion of a standardised liquid meal
Other intervention name(s): Apidra; Insuman
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment