Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01490099
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 12.2

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomised, Single Centre, Double-blind, Two-period Cross-over Glucose Clamp Trial to Demonstrate Bioequivalence Between Insulin Detemir Produced by the NN729 Process and Insulin Detemir Produced by the Current Process in Healthy Subjects
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment period 1	Drug: insulin detemir; One single dose of insulin detemir produced by current process and the NN729 process injected subcutaneously on two separate dosing visits in varying order
Active Comparator: Treatment period 2	Drug: insulin detemir; One single dose of insulin detemir produced by current process and the NN729 process injected subcutaneously on two separate dosing visits in varying order

Outcome Measures

Primary Outcome Measures

1. AUC0-36h, area under the serum insulin detemir concentration curve [From 0 to 36 hours]

2. Cmax, maximum serum insulin detemir concentration []

Secondary Outcome Measures

1. AUC, area under the serum insulin detemir concentration curve []

2. Time to maximum concentration (tmax) []

3. Terminal half life (t½) []

4. Area under the Curve Glucose Infusion Rate (AUCGIR) []

5. Adverse events []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator

• Body mass index (BMI) between 18.0 and 27.0 kg/m^2, inclusive

• Non-smoker

• Fasting plasma glucose (FPG) maximum 6.0 mmol/L

Exclusion Criteria:

• Known or suspected allergy to trial products or related products

• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)

• A history of alcohol or drug abuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		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: NCT01490099
• Other Study ID Numbers: EX1729-1784; 2006-001677-17
• First Posted: Dec 12, 2011
• Last Update Posted: Feb 8, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Insulin Detemir

Study Results

No Results Posted as of Feb 8, 2016