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

This study has been completed.
Sponsor:
Information provided by:
IKFE Institute for Clinical Research and Development
ClinicalTrials.gov Identifier:
NCT00562133
First received: November 20, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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 Intervention Phase
Diabetes Mellitus
Drug: Insulin Glulisine
Drug: Insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by IKFE Institute for Clinical Research and Development:

Primary Outcome Measures:
  • the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 1 day ]

Enrollment: 15
Study Start Date: December 2006
Study Completion Date: March 2007
Arms Assigned Interventions
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 Name: 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 Name: Insuman

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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562133

Locations
Germany
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00562133     History of Changes
Other Study ID Numbers: APIDR_L_01896, EudraCT Number 2006-005127-42
Study First Received: November 20, 2007
Last Updated: November 20, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin glulisine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014