A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic Properties of FIAsp in Japanese Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934712
• Other study ID #: NN1218-3918
• Secondary ID: U1111-1121-2896J
• Status: Completed
• Phase: Phase 1
• Start date: August 30, 2013
• Est. completion date: January 28, 2014

Study information

• Verified date: December 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Japan. The aim of the trial is to evaluate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the trial drug on the body) properties of FIAsp (faster-acting insulin aspart) and the currently marketed insulin aspart (NovoRapid®) in Japanese subjects with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 28, 2014
• Est. primary completion date: January 28, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus (as diagnosed clinically) for 12 months or longer

• Body mass index (BMI) 18.5-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

• Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)

• Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Faster-acting insulin aspart
Single dose injected subcutaneously (s.c, under the skin)
• insulin aspart
Single dose injected subcutaneously (s.c, under the skin)

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (3)

Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subje — View Citation

Shiramoto M, Nishida T, Hansen AK, Haahr H. Fast-acting insulin aspart in Japanese patients with type 1 diabetes: Faster onset, higher early exposure and greater early glucose-lowering effect relative to insulin aspart. J Diabetes Investig. 2018 Mar;9(2): — View Citation

Shiramoto M, Nishida T, Hansen AK, Haahr H. Higher early insulin exposure and greater early glucose-lowering effect with faster-acting insulin aspart vs insulin aspart in Japanese patients with T1D. Diabetes 2015; 64 (Suppl. 1): A249 (983-P)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum insulin aspart concentration-time curve		From 0-1 hour
Secondary	Area under the serum insulin aspart concentration-time curve		From 0-12 hours
Secondary	Area under the glucose infusion rate (GIR) curve		From 0-1 hour
Secondary	Area under the glucose infusion rate (GIR) curve		From 0-12 hours

External Links

•   Clinical Trials at Novo Nordisk