A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart 15 in Subjects With Type 1 Diabetes

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes
• Interventions: Drug: insulin degludec/insulin aspart; Drug: insulin degludec/insulin aspart 15; Drug: insulin degludec; Drug: insulin aspart; Drug: placebo

• Registration Number: NCT01773798
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) and the pharmacokinetic (exposure of the trial drug in the body) properties of insulin degludec/insulin aspart 15 in subjects with type 1 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-18
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-23
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Body mass index 18.0-28.0 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)
• Not able or willing to refrain from smoking, use of nicotine substitute products or transdermal nicotine patches during the inpatient period
• Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, condom with spermizide, sexual abstinence or vasectomised partner)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IDegAsp	insulin degludec/insulin aspart	-
IDegAsp 15	placebo	-
IDegAsp 15	insulin degludec/insulin aspart 15	-
IDegAsp	placebo	-
IDeg + IAsp	insulin degludec	-
IDeg	insulin degludec	-
IAsp	insulin aspart	-
IDeg + IAsp	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
Area under the glucose infusion rate curve	From 0 to 6 hours after single dose (IDegAsp 15, IDeg and IDegAsp)

Secondary Outcome Measures

Name	Time	Method
Area under the serum IDeg concentration-time curve	From 0 to 120 hours after single dose
Area under the serum IAsp concentration-time curve	From 0 to 12 hours after single dose