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

NCT01269606 | Completed Phase 1

• 3 other identifiers: ANA-3877U1111-1117-1353JapicCTI-111383
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

Study Arms (4)

Treatment sequence 1 - IM treatment group

EXPERIMENTAL

Drug: insulin aspart

Treatment sequence 2 - IM treatment group

EXPERIMENTAL

Drug: insulin human

Treatment sequence 1 - IV treatment group

EXPERIMENTAL

Drug: insulin aspart

Treatment sequence 2 - IV treatment group

EXPERIMENTAL

Drug: insulin human

Interventions

insulin aspart DRUG

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.

Treatment sequence 1 - IM treatment group

insulin human DRUG

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.

Treatment sequence 2 - IM treatment group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Fukuoka, 812-0025, Japan

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Aspart; Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

JP (1)