Comparing Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec and Insulin Glargine 300 U/mL at Steady-state Conditions in Subjects With Type 1 Diabetes Mellitus

Phase 1

Completed

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

• Registration Number: NCT02536859
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at steady-state conditions in subjects with type 1 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-28
• Study Start: 2015-08-31
• Study First Posted: 2015-09-01
• Primary Completion: 2016-04-14
• Study Completion: 2016-04-14
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
• Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
• Body mass index 18.5-29.0 kg/m^2 (both inclusive)

Exclusion Criteria

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
• Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the in-patient period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IDeg	insulin degludec	-
IGlar U300	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve	During one dosing interval (0-24h) at steady-state. At day 6, 9 and 12

Secondary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve	During one dosing interval at steady state.At day 6, 9 and 12

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany