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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1
• Interventions: Drug: insulin degludec

• Registration Number: NCT01865318
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-05-27
• Study First Posted: 2013-05-30
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-21
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part 2 (Twice-daily dosing regimen, high concentration)	insulin degludec	-
Part 1 (Once-daily dosing regimen, high concentration)	insulin degludec	-
Part 3 (Once-daily dosing regimen, low concentration)	insulin degludec	-

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve	0-24 hours after dosing

Secondary Outcome Measures

Name	Time	Method
Time to maximum glucose infusion rate (tGIRmax)	0-24 hours after dosing
Maximum glucose infusion rate (GIRmax)	0-24 hours after dosing
Area under the serum insulin degludec curve	0-96 hours after dosing