Comparison of Two Insulin Detemir Formulations in Healthy Volunteers

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: insulin detemir

• Registration Number: NCT01498926
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-26
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glycerol	insulin detemir	-
Mannitol	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Maximum serum insulin concentration
Area under the serum insulin detemir concentration curve

Secondary Outcome Measures

Name	Time	Method
Terminal serum insulin half life
Area under the serum insulin detemir concentration curve
Maximum glucose infusion rate
Area under the glucose infusion rate curve
Time to maximum glucose infusion rate
Adverse events
Time to maximum serum insulin concentration