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 A/S
ClinicalTrials.gov Identifier:
NCT00676819
First received: May 9, 2008
Last updated: June 5, 2012
Last verified: September 2011
  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:


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)) ] [ 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
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
Köln, Germany, 50825
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Julius Vaz, MD Novo Nordisk Canada Inc.
  More Information

Additional Information:
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 July 24, 2014