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Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01698697
First received: September 28, 2012
Last updated: February 28, 2017
Last verified: February 2017
  Purpose
This trial is conducted in Africa. The aim of this trial is to determine if a new formulation (U200) of insulin aspart containing 200 U/mL is bioequivalent to that of a marketed insulin aspart formulation (U100).

Condition Intervention Phase
Diabetes Healthy Drug: insulin aspart Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: A Single Centre, Randomized, Balanced Double-blind, Cross-Over Trial Investigating the Bioequivalence of a Continuous Subcutaneous Infusion of a Marketed NovoRapid Formulation Containing 100 U/ml and a New NovoRapid Formulation Containing 200 U/ml in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the curve (AUC)
  • Area under the glucose infusion rate curve

Secondary Outcome Measures:
  • Cmax (maximum plasma concentration)
  • Time to reach maximum (tmax)
  • Terminal half-life (t½)
  • Incidence of hypoglycemic events
  • Adverse events
  • GIRmax: The maximal GIR (glucose infusion rate)

Enrollment: 24
Actual Study Start Date: September 2, 2002
Study Completion Date: October 18, 2002
Primary Completion Date: October 18, 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: U100 Drug: insulin aspart
Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion
Experimental: U200 Drug: insulin aspart
Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
  • Normal laboratory values, electrocardiogram (ECG), and vital signs unless the investigator considers any abnormality to be clinically irrelevant
  • Body mass index (BMI) 18-26 kg/m^2 (both inclusive)
  • Weight 60-90 kg
  • Non-smoker

Exclusion Criteria:

  • Any condition requiring the regular use of any medication
  • Known or suspected allergy to the trial product or related products
  • Family history of type 1 diabetes mellitus
  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: NCT01698697

Locations
South Africa
Novo Nordisk Investigational Site
Bloemfontein, South Africa, 9324
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01698697     History of Changes
Other Study ID Numbers: NN248-1494
Study First Received: September 28, 2012
Last Updated: February 28, 2017

Additional relevant MeSH terms:
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 July 21, 2017