Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498926
• Other study ID #: NN304-1685
• Secondary ID: 2005-002481-11
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2011
• Last updated: January 13, 2015
• Start date: November 2005
• Est. completion date: February 2006

Study information

• Verified date: January 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• insulin detemir
Single dose containing mannitol as isotonic agent. Administered subcutaneously (s.c., under the skin)
• insulin detemir
Single dose containing glycerol as isotonic agent. Administered subcutaneously (s.c., under the skin)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin detemir concentration curve			No
Primary	Maximum serum insulin concentration			No
Secondary	Area under the glucose infusion rate curve			No
Secondary	Time to maximum serum insulin concentration			No
Secondary	Terminal serum insulin half life			No
Secondary	Area under the serum insulin detemir concentration curve			No
Secondary	Maximum glucose infusion rate			No
Secondary	Time to maximum glucose infusion rate			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk