Bioequivalence of Two NovoLog® Formulations in Subjects With Type 1 Diabetes

NCT01464099 | Completed Phase 1

• 1 other identifier: ANA-3501
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the clinical performance of two formulations of insulin aspart (NovoLog®) in subjects with type 1 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• Area under the insulin aspart bolus concentration-time curve

  From 0 and up to 12 hours post bolus dose administration

• Maximum plasma concentration (Cmax) of insulin aspart

  From 0 and up to 12 hours post bolus dose administration

Secondary Outcomes (2)

• Time to maximum concentration (Tmax) of insulin aspart

  From 0-12 hours post bolus dose administration

• AUC (area under the curve) of insulin aspart

  From -4 to 0 hours after dose administration

Study Arms (2)

Insulin aspart 100U/mL

ACTIVE COMPARATOR

Drug: insulin aspart

Insulin aspart 200U/mL

EXPERIMENTAL

Drug: insulin aspart

Interventions

insulin aspart DRUG

An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion

Insulin aspart 100U/mL

Eligibility Criteria

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

You may qualify if:

• Subjects with type 1 diabetes treated with insulin for at least 12 months
• BMI (Body Mass Index) between 18.0-29.0 kg/m\^2
• Negative fasting C-peptide (below or equal to 0.6 ng/mL)
• HbA1c (glycosylated haemoglobin A1c) below or equal to 10.0%
• Current treatment with insulin below or equal to 1.2 U/kg/day
• Subject should be in good health based on medical history, physical examination and routine laboratory data

You may not qualify if:

• Any known/suspected allergies to trial medication or similar products/devices
• A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
• Clinically significant active disease of any kind
• Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
• Blood donation (more than 500 mL) within the previous 9 weeks

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Chula Vista, California, 91911, United States

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

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

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 3, 2011
• Study Start: June 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

US (1)