A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Geriatric and Younger Adult Subjects With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Geriatric and Younger Adult Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003677
• Other study ID #: NN1218-3891
• Secondary ID: 2011-002626-46U1
• Status: Completed
• Phase: Phase 1
• Start date: November 29, 2013
• Est. completion date: August 14, 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 Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body)properties of FIAsp (faster-acting insulin aspart) in geriatric and younger adult subjects with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 14, 2014
• Est. primary completion date: August 14, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female aged 18-35 years (both inclusive) (younger adult group) or below or equal to 65 years (geriatric group) at the time of signing informed consent

• Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months

• 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
Subjects - in a euglycaemic clamp setting - will receive a single dose. The trial products will be administered subcutaneously (s.c. under the skin).
• insulin aspart
Subjects - in a euglycaemic clamp setting - will receive a single dose. The trial products will be administered subcutaneously (s.c. under the skin).

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

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

Heise T, Hövelmann U, Zijlstra E, Stender-Petersen K, Jacobsen JB, Haahr H. A Comparison of Pharmacokinetic and Pharmacodynamic Properties Between Faster-Acting Insulin Aspart and Insulin Aspart in Elderly Subjects with Type 1 Diabetes Mellitus. Drugs Agi — View Citation

Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. Faster Onset and Greater Early Exposure and Glucose-Lowering Effect with Faster-Acting Insulin Aspart vs. Insulin Aspart: A Pooled Analysis in Subjects with Type 1 Diabetes. Diabetes. 2016; Suppl. 1: A239. doi:10.2337/db16-861-1374 http://dx.doi.org/10.2337/db16-861-1374

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the glucose infusion rate curve		From 0 to 12 hours
Secondary	Area under the serum insulin aspart concentration-time curve		From 0 to 12 hours
Secondary	Maximum observed serum insulin aspart concentration		From 0 to 12 hours

External Links

•   Clinical Trials at Novo Nordisk