Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses

Profil Institut für Stoffwechselforschung

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: human regular insulin; Drug: insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT00513643

ISPS_Dose-ranging

Details and patient eligibility

About

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

Full 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).

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 6 patient groups

1

Experimental group

Description:

6 U insulin aspart

Treatment:

Drug: insulin aspart

2

Experimental group

Description:

12 U insulin aspart

Treatment:

Drug: insulin aspart

3

Experimental group

Description:

24 U insulin aspart

Treatment:

Drug: insulin aspart

4

Active Comparator group

Description:

6 IU human regular insulin

Treatment:

Drug: human regular insulin

5

Active Comparator group

Description:

12 IU human regular insulin

Treatment:

Drug: human regular insulin

6

Active Comparator group

Description:

24 IU human regular insulin

Treatment:

Drug: human regular insulin