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Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01698697
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Healthy Drug: insulin aspart Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (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
Actual Study Start Date : September 2, 2002
Actual Primary Completion Date : October 18, 2002
Actual Study Completion Date : October 18, 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Area under the curve (AUC)
  2. Area under the glucose infusion rate curve

Secondary Outcome Measures :
  1. Cmax (maximum plasma concentration)
  2. Time to reach maximum (tmax)
  3. Terminal half-life (t½)
  4. Incidence of hypoglycemic events
  5. Adverse events
  6. GIRmax: The maximal GIR (glucose infusion rate)


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01698697     History of Changes
Other Study ID Numbers: NN248-1494
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 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