Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT00513643
First received: August 8, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00513643     History of Changes
Other Study ID Numbers: ISPS_Dose-ranging
Study First Received: August 8, 2007
Last Updated: August 8, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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 aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014