A Trial Investigating the Effect of NN1250 in Japanese Subjects With Type 1 Diabetes

NCT01135927 | Completed Phase 1

• 3 other identifiers: NN1250-1996U1111-1113-6722JapicCTI-101158
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Japan. The aim of this clinical trial is to investigate the effect of NN1250 (insulin degludec) in Japanese subjects with type 1 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Area under the NN1250 GIR (glucose infusion rate) curve

  During one dosing interval at steady state

Secondary Outcomes (1)

• Area under the serum insulin detemir concentration-time curve

  During one dosing interval at steady state

Study Arms (2)

A

EXPERIMENTAL

Drug: insulin degludec

B

ACTIVE COMPARATOR

Drug: insulin detemir

Interventions

insulin degludec DRUG

NN1250 (insulin degludec) injected s.c. (under the skin) once daily for 6 days

A

insulin detemir DRUG

Insulin detemir injected s.c. (under the skin) once daily for 6 days

B

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 or continuous subcutaneous insulin infusion (CSII) for at least 12 months
• Current daily basal insulin requirement above or equal to 0.3 (I)U/kg/day
• Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0% (one retest within a week is permitted with the result of the last test being conclusive)

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 screening
• Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening
• Smoker (defined as a subject who is smoking more than 5 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 (only clamp period)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 130-0004, Japan

Location

Related Publications (1)

• Ikushima I, Kaku K, Hirao K, Bardtrum L, Haahr H. Pharmacokinetic and pharmacodynamic properties of insulin degludec in Japanese patients with type 1 diabetes mellitus reflect similarities with Caucasian patients. J Diabetes Investig. 2016 Mar;7(2):270-5. doi: 10.1111/jdi.12399. Epub 2015 Aug 27.

  PMID: 27042281 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

insulin degludec; Insulin Detemir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-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: May 31, 2010
• First Posted: June 3, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

JP (1)