Bioequivalence of Two Insulatard® Formulations in Healthy Subjects

Healthy Clinical Trial

Official title:

A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulatard® (600 Nmol/ml) and Insulatard® (1998 Nmol/ml) in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486901
• Other study ID #: EX1000-1736
• Secondary ID: 2005-006049-18
• Status: Completed
• Phase: Phase 1
• First received: December 5, 2011
• Last updated: April 27, 2015
• Start date: May 2006
• Est. completion date: July 2006

Study information

• Verified date: April 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 2006
• Est. primary completion date: July 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 18.0 and 27.0 kg/m^2, inclusive

• Non-smoker, defined as no nicotine consumption for at least one year

• Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)

Exclusion Criteria:

• Previous participation in this trial or other clinical trials within the last 3 months

• Body weight above 87.5 kg

• 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, or sterilisation, or the oral contraceptive pill, which should have been taken without difficulty for at least 3 months, an approved hormonal implant)

• History of alcohol or drug abuse

Study Design

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• isophane human insulin
Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin concentration-time curve (AUC 0-24 hours)			No
Primary	Maximum serum insulin concentration (Cmax)			No
Secondary	Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)			No
Secondary	Time to maximum serum insulin concentration (tmax)			No
Secondary	Terminal serum insulin half life (t½)			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk