Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses

Diabetes Mellitus Clinical Trial

Official title:

Pharmacodynamic and Pharmacokinetic Properties of Insulin Aspart: Dose - Ranging vs. Human Soluble Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513643
• Other study ID #: ISPS_Dose-ranging
• Status: Completed
• Phase: Phase 1
• First received: August 8, 2007
• Last updated: August 8, 2007
• Start date: April 2002
• Est. completion date: June 2002

Study information

• Verified date: August 2007
• Source: Profil Institut für Stoffwechselforschung GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• insulin aspart
6, 12, 24 U s.c.
• human regular insulin
6, 12 and 24 IU sc

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (2)

Lead Sponsor	Collaborator
Profil Institut für Stoffwechselforschung GmbH	Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC GIR 360-720 min		at each dosing (6 times during the trial)
Secondary	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		at each dosing visit (6 times during the study)
Secondary	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		at each dosing visit (6 times during the study)

External Links

•   Profil Institut für Stoffwechselforschung