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Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

NCT ID: NCT02568280

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-06

Study Completion Date

2016-04-25

Brief Summary

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This trial is conducted in Europe. The aim of the trial is to investigate the postprandial glucose metabolism after treatment with faster-acting insulin aspart in 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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Faster aspart

Group Type EXPERIMENTAL

Faster-acting insulin aspart

Intervention Type DRUG

Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.

Insulin aspart

Group Type ACTIVE_COMPARATOR

insulin aspart

Intervention Type DRUG

Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.

Interventions

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Faster-acting insulin aspart

Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.

Intervention Type DRUG

insulin aspart

Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
* Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria

* Smoker (defined as a subject who is smoking at least five cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the inpatient period
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 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

Graz, , Austria

Site Status

Countries

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Austria

References

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Basu A, Pieber TR, Hansen AK, Sach-Friedl S, Erichsen L, Basu R, Haahr H. Greater early postprandial suppression of endogenous glucose production and higher initial glucose disappearance is achieved with fast-acting insulin aspart compared with insulin aspart. Diabetes Obes Metab. 2018 Jul;20(7):1615-1622. doi: 10.1111/dom.13270. Epub 2018 Mar 30.

Reference Type RESULT
PMID: 29493118 (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)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2014-004144-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1162-2053

Identifier Type: OTHER

Identifier Source: secondary_id

NN1218-3922

Identifier Type: -

Identifier Source: org_study_id