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

NCT ID: NCT02003677

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-29

Study Completion Date

2014-08-14

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FIAsp followed by NovoRapid®

Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days

Group Type EXPERIMENTAL

Faster-acting insulin aspart

Intervention Type DRUG

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

NovoRapid® followed by Insulin aspart

Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days

Group Type ACTIVE_COMPARATOR

insulin aspart

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

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).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Neuss, , Germany

Site Status

Countries

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Germany

References

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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

Reference Type BACKGROUND

Heise T, Hovelmann 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 Aging. 2017 Jan;34(1):29-38. doi: 10.1007/s40266-016-0418-6.

Reference Type RESULT
PMID: 27873152 (View on PubMed)

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 Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.

Reference Type RESULT
PMID: 30402720 (View on PubMed)

Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet. 2017 May;56(5):551-559. doi: 10.1007/s40262-017-0514-8.

Reference Type DERIVED
PMID: 28205039 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2011-002626-46

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1121-8758

Identifier Type: OTHER

Identifier Source: secondary_id

NN1218-3891

Identifier Type: -

Identifier Source: org_study_id