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

Diabetes Clinical Trial

Official title:

A Trial Comparing the Pharmacokinetic Properties of Insulin Aspart With Fast-acting Insulin Human Following Intravenous Infusion or Intramuscular Injection in Japanese Subjects With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269606
• Other study ID #: ANA-3877
• Secondary ID: U1111-1117-1353J
• Status: Completed
• Phase: Phase 1
• First received: January 3, 2011
• Last updated: June 13, 2014
• Start date: January 2011
• Est. completion date: March 2011

Study information

• Verified date: June 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labour and Welfare (MHLW)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin aspart
At the first treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. At the second treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.
• insulin human
At the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.At the second treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.
• insulin aspart
At the first treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. At the second treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.
• insulin human
At the first treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. At the second treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance at steady state (CLss) for IV treatment group		from 180 min to 240 min	No
Primary	Area under the curve (AUC) for IM treatment group		from 0 to 480 min after intramuscular injection	No
Secondary	Area under the curve (AUC) for IM treatment group		from 0 minutes to infinite time after intramuscular injection	No
Secondary	Steady state concentration (Css) for IV treatment group		from 180 min to 240 min	No
Secondary	Hypoglycaemic episodes		from screening (visit 1) to follow-up visit (2-21 days after last trial product administration)	No
Secondary	Adverse Events (AEs)		from first trial related activity to follow-up visit (2-21 days after last trial product administration)	No

External Links

•   Clinical Trials at Novo Nordisk