Metabolic Effect of Insulin Aspart and Human Insulin in Different Doses

NCT00513643 | Completed Phase 1

• 1 other identifier: ISPS_Dose-ranging
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus

Keywords

euglycaemic glucose clamp; duration of action; late metabolic activity; hypoglycaemia

Outcome Measures

Primary Outcomes (1)

• AUC GIR 360-720 min

  at each dosing (6 times during the trial)

Secondary Outcomes (2)

• 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)

• 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)

Study Arms (6)

1

EXPERIMENTAL

6 U insulin aspart

Drug: insulin aspart

2

EXPERIMENTAL

12 U insulin aspart

Drug: insulin aspart

3

EXPERIMENTAL

24 U insulin aspart

Drug: insulin aspart

4

ACTIVE COMPARATOR

6 IU human regular insulin

Drug: human regular insulin

5

ACTIVE COMPARATOR

12 IU human regular insulin

Drug: human regular insulin

6

ACTIVE COMPARATOR

24 IU human regular insulin

Drug: human regular insulin

Interventions

insulin aspart DRUG

6, 12, 24 U s.c.

Also known as: Novorapid

1; 2; 3

human regular insulin DRUG

6, 12 and 24 IU sc

Also known as: Actrapid

4; 5; 6

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Profil Institut für Stoffwechselforschung GmbH: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Related Links

• Profil Institut für Stoffwechselforschung

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia

Interventions

Insulin Aspart; Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Officials

• Tim Heise, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 9, 2007
• Study Start: April 1, 2002
• Study Completion: June 1, 2002
• Last Updated: August 9, 2007

Record last verified: 2007-08

Locations

DE (1)