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Comparison of Two Insulin Aspart Formulations in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01698697
First received: September 28, 2012
Last updated: October 2, 2012
Last verified: September 2012
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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) [ Designated as safety issue: No ]
  • Area under the glucose infusion rate curve [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum plasma concentration) [ Designated as safety issue: No ]
  • Time to reach maximum (tmax) [ Designated as safety issue: No ]
  • Terminal half-life (t½) [ Designated as safety issue: No ]
  • Incidence of hypoglycemic events [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • GIRmax: The maximal GIR (glucose infusion rate) [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2002
Study Completion Date: October 2002
Primary Completion Date: October 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
Genders 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
Bloemfontein, South Africa, 9324
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Birgitte Bentz Damholt, Ph.D. Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, 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: October 2, 2012
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Insulin
Insulin Aspart
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014