Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01486914
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.2
• Patients Per Site Per Month: 23.7

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare insulin aspart produced by current process and the NN2000 process.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Healthy	Drug: insulin aspart	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 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 NovoRapid® Produced by the Current Process and Insulin Aspart With the Same Formulation as NovoRapid®, Produced by the NN2000 Process
• Actual Study Start Date: Jan 19, 2003
• Actual Primary Completion Date: Feb 24, 2003
• Actual Study Completion Date: Feb 24, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NN2000	Drug: insulin aspart; Single dose of each formulation administrated subcutaneously (s.c., under the skin) at two separate dosing visits
Active Comparator: IAsp	Drug: insulin aspart; Single dose of each formulation administrated subcutaneously (s.c., under the skin) at two separate dosing visits

Outcome Measures

Primary Outcome Measures

1. Area under the Curve (AUC) (insulin aspart) []

Secondary Outcome Measures

1. Cmax (maximum plasma concentration) []

2. Terminal half life (t½) []

3. Incident of hypoglycaemic episodes []

4. Adverse events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Healthy

• Caucasian

• Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant

• Fasting blood glucose below or equal to 6 mmol/L

• Body mass index (BMI) 22.0-27.0 kg/m^2 (both inclusive)

Exclusion Criteria:

• Participated in another clinical study with an investigational drug within the last 4 weeks

• Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable

• Known or suspected allergy to the trial product or related products

• Family history of type 2 diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Manchester		United Kingdom	M15 6SH

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01486914
• Other Study ID Numbers: NN2000-1512
• First Posted: Dec 7, 2011
• Last Update Posted: Mar 1, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Insulin Aspart

Study Results

No Results Posted as of Mar 1, 2017