NCT00969592

Brief Summary

The purpose of this study was to compare the pharmacodynamics (course of the blood glucose-lowering effect and duration of effect) and pharmacokinetics (course of the concentration of study medication in the blood) of a single subcutaneous dose of 0.2 units/kg of insulin glulisine and insulin aspart in a direct head-to-head comparison during two euglycemic glucose clamps in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Nov 2007

Typical duration for phase_1 diabetes

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

November 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
Last Updated

September 2, 2009

Status Verified

September 1, 2009

Enrollment Period

1 month

First QC Date

August 31, 2009

Last Update Submit

September 1, 2009

Conditions

Diabetes

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

  • fractional and total glucose infusion rates

    0-1 hours, 0-2 hours, and time to 10% of GIRmax

Secondary Outcomes (1)

  • fractional and total insulin areas under the curve (AUC)

    0-1 hours, 0-2 hours, 0-10 hours

Study Arms (2)

insulin glulisine, insulin aspart

ACTIVE COMPARATOR

insulin glulisine administration during first glucose clamp, insulin aspart administration during second glucose clamp

Drug: insulin glulisine, insulin aspart

insulin aspart, insulin glulisine

ACTIVE COMPARATOR

insulin aspart administration during first euglycemic clamp, insulin glulisine administration during second clamp

Drug: insulin aspart, insulin glulisine

Interventions

insulin glulisine, insulin aspartDRUG

single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during second euglycemic glucose clamp

Also known as: Apidra, NovoRapid
insulin glulisine, insulin aspart
insulin aspart, insulin glulisineDRUG

single subcutaneous dose of 0.2 units per kg body weight of insulin aspart during first euglycemic glucose clamp, single subcutaneous dose of 0.2 units per kg body weight of insulin glulisine during second euglycemic glucose clamp

Also known as: NovoRapid, Apidra
insulin aspart, insulin glulisine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overtly healthy males or females (Women: contraception, Pearl Index \<1%)
  • Between the ages of 18 and 65 years
  • Body Mass Index of \<= 27 kg/m²
  • Safety lab within reference range
  • Normal blood pressure and heart rate
  • Sufficient venous access
  • Written informed consent approved by the Ethical Review Board
  • HbA1c and fasting plasma glucose in the normal range

You may not qualify if:

  • Investigative site personnel directly affiliated with this study and their immediate families or the sponsor´s employees
  • Within 30 days of the initial dose of study drug had received treatment with a drug that had not received regulatory approval
  • Known allergies to insulin or related compounds
  • Regular treatment with any drug, both over-the-counter or prescribed
  • an abnormality in the 12-lead ECG increasing the risk for participation
  • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
  • Significant active neuropsychiatric disease
  • Regular use of drugs of abuse and or positive findings on urinary drug screening
  • Evidence of HIV and/or positive antibodies 1 or 2 and or HIV1 antigen
  • Evidence of hepatitis B and/or positive hepatitis C antibody
  • Evidence of hepatitis B and/or positive hepatitis B surface antigen
  • Women with a positive pregnancy test or breastfeeding women
  • Blood donation more than 500 mL within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, D-41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin glulisineInsulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Sabine Arnolds, MD

    Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 1, 2009

Study Start

November 1, 2007

Primary Completion

December 1, 2007

Study Completion

June 1, 2008

Last Updated

September 2, 2009

Record last verified: 2009-09

Locations

DE(1)