NCT00562133

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_3 diabetes-mellitus

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_3 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
Last Updated

November 21, 2007

Status Verified

November 1, 2007

First QC Date

November 20, 2007

Last Update Submit

November 20, 2007

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • the postprandial time course of nitrotyrosine after injection of insulin glulisine compared with regular human insulin

    1 day

Secondary Outcomes (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

Study Arms (2)

1

EXPERIMENTAL

One Day Treatment with Insulin Glulisine

Drug: Insulin Glulisine

2

ACTIVE COMPARATOR

One day Treatment with Human insulin

Drug: Insulin

Interventions

Insulin GlulisineDRUG

100 IU/ml, 0.10 U/kg immediately before ingestion of a standardised liquid meal

Also known as: Apidra
1
InsulinDRUG

100 IU/ml, 0.10 U/kg 15 Minutes before ingestion of a standardised liquid meal

Also known as: Insuman
2

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ikfe

Mainz, Rhineland-Palatinate, 55116, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin glulisineInsulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Thomas A Forst, Prof, MD

    Institute for Clinical Research and Development

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 21, 2007

Study Start

December 1, 2006

Study Completion

March 1, 2007

Last Updated

November 21, 2007

Record last verified: 2007-11

Locations

DE(1)