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Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00513643
First Posted: August 9, 2007
Last Update Posted: August 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novo Nordisk A/S
Information provided by:
Profil Institut für Stoffwechselforschung GmbH
  Purpose
The metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique.

Condition Intervention Phase
Diabetes Mellitus Drug: insulin aspart Drug: human regular insulin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacodynamic and Pharmacokinetic Properties of Insulin Aspart: Dose - Ranging vs. Human Soluble Insulin

Resource links provided by NLM:


Further study details as provided by Profil Institut für Stoffwechselforschung GmbH:

Primary Outcome Measures:
  • AUC GIR 360-720 min [ Time Frame: at each dosing (6 times during the trial) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 16
Study Start Date: April 2002
Study Completion Date: June 2002
Arms Assigned Interventions
Experimental: 1
6 U insulin aspart
Drug: insulin aspart
6, 12, 24 U s.c.
Other Name: Novorapid
Experimental: 2
12 U insulin aspart
Drug: insulin aspart
6, 12, 24 U s.c.
Other Name: Novorapid
Experimental: 3
24 U insulin aspart
Drug: insulin aspart
6, 12, 24 U s.c.
Other Name: Novorapid
Active Comparator: 4
6 IU human regular insulin
Drug: human regular insulin
6, 12 and 24 IU sc
Other Name: Actrapid
Active Comparator: 5
12 IU human regular insulin
Drug: human regular insulin
6, 12 and 24 IU sc
Other Name: Actrapid
Active Comparator: 6
24 IU human regular insulin
Drug: human regular insulin
6, 12 and 24 IU sc
Other Name: Actrapid

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).

  Eligibility

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00513643


Locations
Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
Novo Nordisk A/S
Investigators
Principal Investigator: Tim Heise, MD Profil Institut für Stoffwechselforschung GmbH
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00513643     History of Changes
Other Study ID Numbers: ISPS_Dose-ranging
First Submitted: August 8, 2007
First Posted: August 9, 2007
Last Update Posted: August 9, 2007
Last Verified: August 2007

Keywords provided by Profil Institut für Stoffwechselforschung GmbH:
euglycaemic glucose clamp
duration of action
late metabolic activity
hypoglycaemia

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs