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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014