Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes - Full Text View

Sponsored by:	IKFE Institute for Clinical Research and Development
Information provided by:	IKFE Institute for Clinical Research and Development
ClinicalTrials.gov Identifier:	NCT00562133

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glulisine

U.S. FDA Resources

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
1: Experimental One Day Treatment with Insulin Glulisine	Drug: Insulin Glulisine 100 IU/ml, 0.10 U/kg immediately before ingestion of a standardised liquid meal
2: Active Comparator One day Treatment with Human insulin	Drug: Insulin 100 IU/ml, 0.10 U/kg 15 Minutes before ingestion of a standardised liquid meal

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:

Type 2 Diabetes mellitus according to the ADA criteria
HbA1c between 6.5 % and 9.9 %
Monotherapy with sulfonylurea or combined with Metformin in a stable dosage within the last 3 months
Age between 40 and 70 years
BMI < 40

Exclusion Criteria:

Type 1 Diabetes mellitus
Pre-Treatment with insulin within the last 6 months prior to screening
Treatment with glitazones within the last 6 months prior to screening
Pre-Treatment with PPARy-agonists, glinides or glucosidase inhibitors within the last 4 weeks prior to screening
Untreated hypertension stage II-III according to WHO criteria
Planned or anticipated change in antidiabetic and/or concomitant medication during study participation
Total Cholesterol > 300 mg/dl (anamnestically)
Hypokalemia (K < 3.5 mmol /l)
Major micro- or macrovascular complications as judged by the investigator
Tobacco use within the last 12 months prior to screening
Drugs with major impact on endothelial function like nitrates etc.
History of drug or alcohol abuse within the last five years prior to screening
Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
History of severe or multiple allergies
Treatment with any other investigational drug within 3 months prior to screening
Progressive fatal disease
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
Pregnancy or breast feeding
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
Lack of compliance or other similar reason, that according to investigator, precludes satisfactory participation in the study

Contacts and Locations

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

Locations

Germany, Rhineland-Palatinate
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

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

Study placed in the following topic categories:

Hypoglycemic Agents
Insulin glulisine
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Stress
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Insulin glulisine
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 10, 2009