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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: insulin human

Study type: Interventional

Funder types: Industry

Identifiers

NCT01269606

ANA-3877

JapicCTI-111383 (Other Identifier)

U1111-1117-1353 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 4 patient groups

Treatment sequence 1 - IM treatment group

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin aspart

Treatment sequence 2 - IM treatment group

Experimental group

Treatment:

Drug: insulin human

Drug: insulin human

Treatment sequence 1 - IV treatment group

Experimental group

Treatment:

Drug: insulin aspart

Drug: insulin aspart

Treatment sequence 2 - IV treatment group

Experimental group

Treatment:

Drug: insulin human

Drug: insulin human