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Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses

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ClinicalTrials.gov Identifier: NCT00513643
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : August 9, 2007
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Profil Institut für Stoffwechselforschung GmbH

Tracking Information
First Submitted Date  ICMJE August 8, 2007
First Posted Date  ICMJE August 9, 2007
Last Update Posted Date August 9, 2007
Study Start Date  ICMJE April 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2007)
AUC GIR 360-720 min [ Time Frame: at each dosing (6 times during the trial) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2007)
  • PK endpoints such as C max/ins, t max/ins, AUC ins 0-120 min, AUC ins 360-720 min, AUC ins 0-720 min [ Time Frame: at each dosing visit (6 times during the study) ]
  • PD endpoints like GIR max, t max/GIR, AUC GIR 0-120 min, AUC GIR 0-720 min, t >2/GIR, early and late t 50%/GIR [ Time Frame: at each dosing visit (6 times during the study) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses
Official Title  ICMJE Pharmacodynamic and Pharmacokinetic Properties of Insulin Aspart: Dose - Ranging vs. Human Soluble Insulin
Brief Summary The metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique.
Detailed Description

Double-blind, randomized, 6-period cross-over study in 16 healthy subjects. Each patient participates in 6 euglycemic glucose clamp experiments each.

The time interval between the study days is 2 to 28 days. At the clamp visits, subjects are connected to a Biostator (MTB Medizintechnik, Ulm, Germany) and receive an intravenous human insulin infusion (rate of 0.15 mU/kg/min) over the duration of each experiment to prevent a rise in endogenous insulin secretion. After a baseline period of 2 h the trial drug (6, 12, or 24 U of either Insulin Aspart or regular human insulin in random order) are administered s.c. with a syringe into the abdominal wall. Glucose infusion rates (GIR) necessary to keep blood glucose concentrations close to the clamp level of 90 mg/dl (5 mmol/l) are administered and recorded by the Biostator every minute for a period of 12 h post-dosing. Blood samples are drawn at regular intervals for the analysis of C-peptide and (depending on the trial drug administered) serum insulin or serum Insulin Aspart concentrations (measured with specific ELISAs).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • Drug: insulin aspart
    6, 12, 24 U s.c.
    Other Name: Novorapid
  • Drug: human regular insulin
    6, 12 and 24 IU sc
    Other Name: Actrapid
Study Arms  ICMJE
  • Experimental: 1
    6 U insulin aspart
    Intervention: Drug: insulin aspart
  • Experimental: 2
    12 U insulin aspart
    Intervention: Drug: insulin aspart
  • Experimental: 3
    24 U insulin aspart
    Intervention: Drug: insulin aspart
  • Active Comparator: 4
    6 IU human regular insulin
    Intervention: Drug: human regular insulin
  • Active Comparator: 5
    12 IU human regular insulin
    Intervention: Drug: human regular insulin
  • Active Comparator: 6
    24 IU human regular insulin
    Intervention: Drug: human regular insulin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2007)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Signed informed consent obtained before any trial-related activities
  • Healthy subjects between 18 and 45 years inclusive
  • Considered generally healthy upon completion of medical history and physical examination
  • Body mass index (BMI) < 27 kg/m2
  • HbA1c < 6,1 %
  • Non-smoker for at least three months
  • Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD), the oral contraceptive pill or barrier methods.

Exclusion Criteria:

  • Participation in any other clinical trial and receipt of any investigational drug within four weeks prior to this trial
  • Previous participation in this trial
  • Clinically significant abnormal haematology or biochemistry screening test
  • Any disease requiring use of non topical prescription medicines
  • Any serious systemic infectious disease that occurred in the four weeks prior to the first dose of test drug
  • Any intercurrent illness that may affect blood glucose
  • Current addiction to alcohol or substances of abuse as determined by the investigator
  • Known or suspected allergy against insulin or any component of the composition of the trial drug
  • Blood donation > 500 ml within the last nine weeks
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
  • If female, subject is pregnant or lactating
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00513643
Other Study ID Numbers  ICMJE ISPS_Dose-ranging
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Profil Institut für Stoffwechselforschung GmbH
Collaborators  ICMJE Novo Nordisk A/S
Investigators  ICMJE
Principal Investigator: Tim Heise, MD Profil Institut für Stoffwechselforschung GmbH
PRS Account Profil Institut für Stoffwechselforschung GmbH
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP