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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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00676819
First received: May 9, 2008
Last updated: March 15, 2017
Last verified: March 2017
  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 Blind (masked roles unspecified)
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

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
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: 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
Study First Received: May 9, 2008
Last Updated: March 15, 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

ClinicalTrials.gov processed this record on March 27, 2017