Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01498926
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 11.2

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomised, Single Centre, Two-period, Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Two Insulin Detemir Formulations Containing Mannitol and Glycerol as Isotonic Agents Respectively, in Healthy Subjects
• Study Start Date: Nov 1, 2005
• Actual Primary Completion Date: Feb 1, 2006
• Actual Study Completion Date: Feb 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glycerol	Drug: insulin detemir; Single dose containing glycerol as isotonic agent. Administered subcutaneously (s.c., under the skin)
Active Comparator: Mannitol	Drug: insulin detemir; Single dose containing mannitol as isotonic agent. Administered subcutaneously (s.c., under the skin)

Outcome Measures

Primary Outcome Measures

1. Area under the serum insulin detemir concentration curve []

2. Maximum serum insulin concentration []

Secondary Outcome Measures

1. Area under the glucose infusion rate curve []

2. Time to maximum serum insulin concentration []

3. Terminal serum insulin half life []

4. Area under the serum insulin detemir concentration curve []

5. Maximum glucose infusion rate []

6. Time to maximum glucose infusion rate []

7. 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 and 27 kg/m^2, inclusive

• Non-smoker

• Fasting plasma glucose maximum 6 mmol/L

Exclusion Criteria:

• Known or suspected allergy to trial products or related products

• Previous participation in this trial

• 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)

• The receipt of any investigational drug within the last 3 months prior to this trial

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.

• ClinicalTrials.gov Identifier: NCT01498926
• Other Study ID Numbers: NN304-1685; 2005-002481-11
• First Posted: Dec 26, 2011
• Last Update Posted: Jan 14, 2015
• Last Verified: Jan 1, 2015

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

Study Results

No Results Posted as of Jan 14, 2015