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Completed

NCT Number: NCT00676819

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site

Cologne, 50825, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin aspart

Drug

Other names: ANA, NovoRapid

human insulin

Drug

Primary outcomes

  1. Glucose infusion rate

    Time frame: in the time period from 0 to 120 min after administration of trial products (AUCGIR(0-120 min))

Secondary outcomes

  1. AUCGIR(0-300 min) the area under the GIR profile

    Time frame: in the interval 0-300 minutes post dosing

  2. 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)

  3. 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)

  4. GIRmax: the maximal GIR value

    Time frame: tmax, GIR: the time to maximal GIR value

  5. early and late t50%, GIR

    Time frame: the time to early and late half-maximal GIR value

  6. 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

  7. 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

  8. 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)

  9. 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)

  10. Cmax,ins: the maximal serum insulin (or serum insulin aspart) concentration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Comparison of the Pharmacodynamics and Pharmacokinetics of Insulin Aspart and Human Soluble Insulin in Geriatric Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2002
Primary completion
2002
Study completion
2002
First posted
May 13, 2008
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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