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Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Insulin in Elderly People With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00676819
First Posted: May 13, 2008
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Europe. The aim of this trial is to investigate if the pharmacodynamic / pharmacokinetic properties of insulin aspart and human soluble insulin are different in elderly (65 years of age or older) with type 2 diabetes.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin aspart Drug: human insulin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Soluble Insulin in Geriatric Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Glucose infusion rate [ Time Frame: in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min)) ]

Secondary Outcome Measures:
  • AUCGIR(0-300 min) the area under the GIR profile [ Time Frame: in the interval 0-300 minutes post dosing ]
  • AUCGIR(0 min-end of clamp) the area under the GIR profile [ Time Frame: in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values) ]
  • AUCGIR(300min-end of clamp) the area under the GIR profile [ Time Frame: in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values) ]
  • GIRmax: the maximal GIR value [ Time Frame: tmax, GIR: the time to maximal GIR value ]
  • early and late t50%, GIR [ Time Frame: the time to early and late half-maximal GIR value ]
  • AUCINS(0-60 min) the area under the serum insulin (or serum insulin aspart) profile [ Time Frame: in the interval 0-60 minutes post dosing ]
  • AUCINS(0-300 min) the area under the serum insulin (or serum insulin aspart) profile [ Time Frame: in the interval 0-300 minutes post dosing ]
  • AUCINS(0min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile [ Time Frame: in the interval 0-600 minutes post dosing (or 0 min until termination of the glucose clamp if abandoned early because of high blood glucose values) ]
  • AUCINS(300min-end of clamp) the area under the serum insulin (or serum insulin aspart) profile [ Time Frame: in the interval 300-600 minutes post dosing (or 300 min until termination of the glucose clamp if abandoned early because of high blood glucose values) ]
  • Cmax,ins: the maximal serum insulin (or serum insulin aspart) concentration

Enrollment: 19
Actual Study Start Date: January 10, 2002
Study Completion Date: July 19, 2002
Primary Completion Date: July 19, 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: insulin aspart
    Other Names:
    • ANA
    • NovoRapid
    Drug: human insulin
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Duration of diabetes for at least 12 months
  • Current treatment with human insulin or insulin analogues for at least 6 months
  • BMI equal to or below 35 kg/m2
  • HbA1c equal to or greater than 10.0 %
  • No clinically significant cardiovascular event as judged by the Investigator within the last 6 months prior to the study

Exclusion Criteria:

  • History of any illness that, in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the trial products to the subject
  • Current treatment with systemic corticosteroids
  • Any positive reaction of drug of abuse or alcohol screen
  • Cardiac problems defined as: decompensated heart failure and/or angina pectoris
  • Uncontrolled treated/untreated hypertension as judged by the Investigator or blood pressure > 180 mm Hg systolic and/or > 110 mm Hg diastolic
  • Known or suspected allergy to trial product or related products
  • Blood donation of more than 500 ml within the last 12 weeks
  • The receipt of any investigational drug within 4 weeks prior to this trial
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676819


Locations
Germany
Novo Nordisk Investigational Site
Köln, Germany, 50825
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00676819     History of Changes
Other Study ID Numbers: ANA-1416
First Submitted: May 9, 2008
First Posted: May 13, 2008
Last Update Posted: March 16, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs


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