Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Single Centre, Open-Label, Multiple Dose Trial Examining the Pharmacodynamic Characteristics of Insulin 454 Under Single-Dose and Steady-State Conditions in Male Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865318
• Other study ID #: NN5401-1740
• Secondary ID: 2006-002212-97
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2013
• Last updated: October 21, 2015
• Start date: September 2006
• Est. completion date: January 2007

Study information

• Verified date: October 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 investigate the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, under single-dose and steady-state conditions in male subjects with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Male and are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator

• Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months

• Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive)

• Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results

Exclusion Criteria:

• History of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator

• Participation in any other trials involving investigational products within 3 months preceding the start of dosing

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin degludec
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

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the glucose infusion rate curve		0-24 hours after dosing	No
Secondary	Maximum glucose infusion rate (GIRmax)		0-24 hours after dosing	No
Secondary	Time to maximum glucose infusion rate (tGIRmax)		0-24 hours after dosing	No
Secondary	Area under the serum insulin degludec curve		0-96 hours after dosing	No

External Links

•   Clinical Trials at Novo Nordisk