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

Conditions

Diabetes, Diabetes Mellitus, Type 1

Brief 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.

Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T.

2019-05-016 citations

10.1007/s40262-018-0718-6

A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes.

Heise T, Pieber TR, Danne T, Erichsen L, Haahr H.

2017-05-01112 citations

10.1007/s40262-017-0514-8

A Comparison of Pharmacokinetic and Pharmacodynamic Properties Between Faster-Acting Insulin Aspart and Insulin Aspart in Elderly Subjects with Type 1 Diabetes Mellitus

Tim Heise, Ulrike Hövelmann, Eric Zijlstra, Kirstine L. Stender-Petersen, Jacob Jacobsen et al. (6 authors)

Drugs & Aging2016-11-2138 citations

10.1007/s40266-016-0418-6

Interventions

DRUGFaster-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).

DRUGinsulin aspart

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Area under the glucose infusion rate curve	From 0 to 12 hours

Secondary

Measure	Time frame
Area under the serum insulin aspart concentration-time curve	From 0 to 12 hours
Maximum observed serum insulin aspart concentration	From 0 to 12 hours

Countries

Germany

Outcome results

None listed