Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01448070
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.2
• Patients Per Site Per Month: 12.9

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Healthy	Drug: human insulin	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 Actrapid® Produced by the Current Process and Human Insulin With the Same Formulation as Actrapid®, Produced by the NN729 Process
• Actual Study Start Date: Oct 15, 2002
• Actual Primary Completion Date: Dec 20, 2002
• Actual Study Completion Date: Dec 20, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NN729 manufacturing process	Drug: human insulin; Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)
Active Comparator: Current manufacturing process	Drug: human insulin; Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)

Outcome Measures

Primary Outcome Measures

1. AUC (area under the curve) 0-8h (human insulin) []

2. Cmax (maximum plasma concentration) []

3. Area under the curve (glucose infusion rate (GIR)), 0-8h []

Secondary Outcome Measures

1. tmax (time to reach maximum) []

2. t½ (terminal half-life) []

3. GIR (glucose infusion rate) max []

4. tGIR (glucose infusion rate) max []

5. Area under the curve (C-peptide, 0-8h) []

6. Physical examinations and vital signs []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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 1 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: NCT01448070
• Other Study ID Numbers: NN729-1511
• First Posted: Oct 7, 2011
• Last Update Posted: Feb 27, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Insulin; Insulin, Globin Zinc

Study Results

No Results Posted as of Feb 27, 2017