Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes

Phase 1

Completed

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

• Registration Number: NCT01269606
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at which rate the body eliminates the substance from the body) of insulin aspart with fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection in Japanese subjects with type 1 diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-13
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
• Treated with multiple daily insulin injections for at least 12 months
• Current daily basal insulin requirement above or equal to 0.3 U/kg/day
• Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0%
• Body Mass Index (BMI) 18.0-28.0 kg/m^2

Exclusion Criteria

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start (screening)
• Surgery or trauma with significant blood loss (more than 500 mL) within 3 months prior to trial start (screening)
• Subject who smokes more than 10 cigarettes or the equivalent per day
• Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment sequence 1 - IM treatment group	insulin aspart	-
Treatment sequence 2 - IM treatment group	insulin human	-
Treatment sequence 1 - IV treatment group	insulin aspart	-
Treatment sequence 2 - IV treatment group	insulin human	-

Primary Outcome Measures

Name	Time	Method
Clearance at steady state (CLss) for IV treatment group	from 180 min to 240 min
Area under the curve (AUC) for IM treatment group	from 0 to 480 min after intramuscular injection

Secondary Outcome Measures

Name	Time	Method
Area under the curve (AUC) for IM treatment group	from 0 minutes to infinite time after intramuscular injection
Steady state concentration (Css) for IV treatment group	from 180 min to 240 min
Hypoglycaemic episodes	from screening (visit 1) to follow-up visit (2-21 days after last trial product administration)
Adverse Events (AEs)	from first trial related activity to follow-up visit (2-21 days after last trial product administration)