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

NCT00676819 | Completed Phase 4

• 1 other identifier: ANA-1416
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Glucose infusion rate

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

Secondary Outcomes (10)

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

  in the interval 0-300 minutes post dosing

• AUCGIR(0 min-end of clamp) the area under the GIR profile

  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

  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

  tmax, GIR: the time to maximal GIR value

• early and late t50%, GIR

  the time to early and late half-maximal GIR value

Interventions

insulin aspart DRUG

Also known as: ANA, NovoRapid

human insulin DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Cologne, 50825, Germany

Location

Related Publications (1)

• Krones R, Schutte C, Heise T. The rapid-acting properties of insulin aspart are preserved in elderly people with type 2 diabetes. Diabetes Obes Metab. 2009 Jan;11(1):41-4. doi: 10.1111/j.1463-1326.2008.00988.x.

  PMID: 19120432 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Aspart; Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2008
• First Posted: May 13, 2008
• Study Start: January 10, 2002
• Primary Completion: July 19, 2002
• Study Completion: July 19, 2002
• Last Updated: March 16, 2017

Record last verified: 2017-03

Locations

DE (1)