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Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes

Sponsor
IKFE Institute for Clinical Research and Development (Other)
Overall Status
Completed
CT.gov ID
NCT00562133
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
3
Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
Phase 3

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

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Prandial Treatment With Insulin Glulisine Compared to Regular Human Insulin on Postprandial Endothelial Function and Microvascular Stress in Type 2 Diabetic Patients
Study Start Date :
Dec 1, 2006
Actual Study Completion Date :
Mar 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

One Day Treatment with Insulin Glulisine

Drug: Insulin Glulisine
100 IU/ml, 0.10 U/kg immediately before ingestion of a standardised liquid meal
Other Names:
  • Apidra

    		•
    Active Comparator: 2

    One day Treatment with Human insulin

    Drug: Insulin
    100 IU/ml, 0.10 U/kg 15 Minutes before ingestion of a standardised liquid meal
    Other Names:
  • Insuman

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin [1 day]

    Secondary Outcome Measures

    1. postprandial time course of blood glucose, insulin, intact proinsulin, ADMA, MMP-9, FFA, ox-LDL, per ox Status, IL-18, postprandial time course of microvascular blood circulation measured with laserdopplerflux at 37 °C and 44 C [1 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Type 2 Diabetes mellitus according to the ADA criteria

    2. HbA1c between 6.5 % and 9.9 %

    3. Monotherapy with sulfonylurea or combined with Metformin in a stable dosage within the last 3 months

    4. Age between 40 and 70 years

    5. BMI < 40

    Exclusion Criteria:

    1. Type 1 Diabetes mellitus

    2. Pre-Treatment with insulin within the last 6 months prior to screening

    3. Treatment with glitazones within the last 6 months prior to screening

    4. Pre-Treatment with PPARy-agonists, glinides or glucosidase inhibitors within the last 4 weeks prior to screening

    5. Untreated hypertension stage II-III according to WHO criteria

    6. Planned or anticipated change in antidiabetic and/or concomitant medication during study participation

    7. Total Cholesterol > 300 mg/dl (anamnestically)

    8. Hypokalemia (K < 3.5 mmol /l)

    9. Major micro- or macrovascular complications as judged by the investigator

    10. Tobacco use within the last 12 months prior to screening

    11. Drugs with major impact on endothelial function like nitrates etc.

    12. History of drug or alcohol abuse within the last five years prior to screening

    13. Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures

    14. History of severe or multiple allergies

    15. Treatment with any other investigational drug within 3 months prior to screening

    16. Progressive fatal disease

    17. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.1 mg/dL in women, > 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator

    18. Pregnancy or breast feeding

    19. Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner

    20. Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ikfe Mainz Rhineland-Palatinate Germany 55116

    Sponsors and Collaborators

    • IKFE Institute for Clinical Research and Development

    Investigators

    • Principal Investigator: Thomas A Forst, Prof, MD, Institute for Clinical Research and Development

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00562133
    Other Study ID Numbers:
    • APIDR_L_01896
    • EudraCT Number 2006-005127-42
    First Posted:
    Nov 21, 2007
    Last Update Posted:
    Nov 21, 2007
    Last Verified:
    Nov 1, 2007
    Additional relevant MeSH terms:
    Insulin
    Insulin, Globin Zinc
    Insulin glulisine

    Study Results

    No Results Posted as of Nov 21, 2007