Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses

NCT ID: NCT00513643

Last Updated: 2007-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2002-06-30

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).

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

6 U insulin aspart

Group Type: EXPERIMENTAL

insulin aspart

Intervention Type: DRUG

6, 12, 24 U s.c.

2

12 U insulin aspart

Group Type: EXPERIMENTAL

insulin aspart

Intervention Type: DRUG

6, 12, 24 U s.c.

3

24 U insulin aspart

Group Type: EXPERIMENTAL

insulin aspart

Intervention Type: DRUG

6, 12, 24 U s.c.

4

6 IU human regular insulin

Group Type: ACTIVE_COMPARATOR

human regular insulin

Intervention Type: DRUG

6, 12 and 24 IU sc

5

12 IU human regular insulin

Group Type: ACTIVE_COMPARATOR

human regular insulin

Intervention Type: DRUG

6, 12 and 24 IU sc

6

24 IU human regular insulin

Group Type: ACTIVE_COMPARATOR

human regular insulin

Intervention Type: DRUG

6, 12 and 24 IU sc

Interventions

insulin aspart

6, 12, 24 U s.c.

Intervention Type: DRUG

human regular insulin

6, 12 and 24 IU sc

Intervention Type: DRUG

Other Intervention Names

Novorapid; Actrapid

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

Sponsor Role: lead

Principal Investigators

Tim Heise, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH

Locations

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Countries

Germany

Related Links

http://www.profil-research.de

Profil Institut für Stoffwechselforschung

Other Identifiers

ISPS_Dose-ranging

Identifier Type: -

Identifier Source: org_study_id