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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:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00676819
First received: May 9, 2008
Last updated: June 5, 2012
Last verified: September 2011
History of Changes
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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)) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUCGIR(0-300 min) the area under the GIR profile [ Time Frame: in the interval 0-300 minutes post dosing ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • GIRmax: the maximal GIR value [ Time Frame: tmax, GIR: the time to maximal GIR value ] [ Designated as safety issue: No ]
  • early and late t50%, GIR [ Time Frame: the time to early and late half-maximal GIR value ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Cmax,ins: the maximal serum insulin (or serum insulin aspart) concentration [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: January 2002
Study Completion Date: July 2002
Primary Completion Date: July 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676819

Locations
Germany
Köln, Germany, 50825
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Julius Vaz, MD Novo Nordisk Canada Inc.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, 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: June 5, 2012
Health Authority: Germany: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013