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A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus

NCT ID: NCT01513473

Last Updated: 2019-06-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-16

Study Completion Date

2013-07-30

Brief Summary

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This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.

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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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin Degludec + Insulin Aspart

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

insulin aspart

Intervention Type DRUG

Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.

Insulin Detemir +Insulin Aspart

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.

insulin aspart

Intervention Type DRUG

Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.

Interventions

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insulin degludec

Injected subcutaneously (under the skin) once daily. Dose individually adjusted.

Intervention Type DRUG

insulin detemir

Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.

Intervention Type DRUG

insulin aspart

Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent, and child assent as age-appropriate, obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The parents or legal representative of the child must sign and date the Informed Consent Form according to local requirements. The child, if possible, parents or legal representative of the child must sign and date the Child Assent Form according to local requirements
* Male or female diagnosed with type 1 diabetes mellitus (T1DM) (based on clinical judgement and supported by laboratory analysis as per local guidelines)
* Ongoing daily treatment with insulin (any regimen) for at least 3 months prior to Visit 1 (screening). No OADs (oral anti-diabetic drugs) are allowed
* HbA1c (glycosylated haemoglobin) maximum 11%

Exclusion Criteria

* Known or suspected hypersensitivity to trial product(s) or related products
* Previous participation in this trial. Participation is defined as randomisation
* Girls who are pregnant, breastfeeding or intend to become pregnant
* Girls who have had menarche and are not using adequate contraceptive measures according to local requirements
* Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the Investigator (trial physician)
* More than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1
* Significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the Investigator's opinion could interfere with the trial
* The receipt of any investigational drug within 1 month prior to Visit 1
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 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

Little Rock, Arkansas, United States

Site Status

Novo Nordisk Investigational Site

Orange, California, United States

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Novo Nordisk Investigational Site

San Diego, California, United States

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Novo Nordisk Investigational Site

Aurora, Colorado, United States

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Novo Nordisk Investigational Site

New Haven, Connecticut, United States

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Novo Nordisk Investigational Site

Gainesville, Florida, United States

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Novo Nordisk Investigational Site

Jacksonville, Florida, United States

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Novo Nordisk Investigational Site

Maitland, Florida, United States

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Novo Nordisk Investigational Site

Melbourne, Florida, United States

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Novo Nordisk Investigational Site

Tallahassee, Florida, United States

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Novo Nordisk Investigational Site

Atlanta, Georgia, United States

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Novo Nordisk Investigational Site

Atlanta, Georgia, United States

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Novo Nordisk Investigational Site

Lexington, Kentucky, United States

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Novo Nordisk Investigational Site

Louisville, Kentucky, United States

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Novo Nordisk Investigational Site

Baltimore, Maryland, United States

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Novo Nordisk Investigational Site

Baltimore, Maryland, United States

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Novo Nordisk Investigational Site

Boston, Massachusetts, United States

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Novo Nordisk Investigational Site

Worcester, Massachusetts, United States

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Novo Nordisk Investigational Site

Buffalo, New York, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Novo Nordisk Investigational Site

Sofia, , Bulgaria

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Novo Nordisk Investigational Site

Varna, , Bulgaria

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Novo Nordisk Investigational Site

Espoo, , Finland

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Novo Nordisk Investigational Site

Kuopio, , Finland

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Mikkeli, , Finland

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OYS, , Finland

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Pori, , Finland

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Bron, , France

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Paris, , France

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Rennes, , France

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Toulouse, , France

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Berlin, , Germany

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Hanover, , Germany

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Novo Nordisk Investigational Site

Ludwigshafen, , Germany

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Münster, , Germany

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Novo Nordisk Investigational Site

Chieti, , Italy

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Novo Nordisk Investigational Site

Genova, , Italy

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Roma, , Italy

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Novo Nordisk Investigational Site

Chuo-shi, Yamanashi, , Japan

Site Status

Novo Nordisk Investigational Site

Fukushima, , Japan

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Novo Nordisk Investigational Site

Iruma-gun, Saitama, , Japan

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Novo Nordisk Investigational Site

Kobe-shi, Hyogo, , Japan

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Novo Nordisk Investigational Site

Kochi-shi, Kochi, , Japan

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Novo Nordisk Investigational Site

Kumamoto-shi, Kumamoto, , Japan

Site Status

Novo Nordisk Investigational Site

Maebashi-shi, Gunma, , Japan

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Novo Nordisk Investigational Site

Musashino-shi, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Niigata-shi, Niigata, , Japan

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Novo Nordisk Investigational Site

Osaka-shi, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Sendai-shi, Miyagi, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Toyonaka-city, Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Tsu-shi, Mie, , Japan

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Novo Nordisk Investigational Site

Almere Stad, , Netherlands

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Novo Nordisk Investigational Site

Amersfoort, , Netherlands

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Eindhoven, , Netherlands

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Skopje, , North Macedonia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Saratov, , Russia

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Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Cape Town, Western Cape, South Africa

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Novo Nordisk Investigational Site

Aberdeen, , United Kingdom

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Novo Nordisk Investigational Site

Birmingham, , United Kingdom

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Novo Nordisk Investigational Site

Manchester, , United Kingdom

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Novo Nordisk Investigational Site

Norwich, , United Kingdom

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Novo Nordisk Investigational Site

Sheffield, , United Kingdom

Site Status

Countries

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United States Bulgaria Finland France Germany Italy Japan Netherlands North Macedonia Russia South Africa United Kingdom

References

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Thalange N, Deeb L, Klingensmith G, Franco DR, Bardtrum L, Tutkunkardas D, Danne T. The rate of hyperglycemia and ketosis with insulin degludec-based treatment compared with insulin detemir in pediatric patients with type 1 diabetes: An analysis of data from two randomized trials. Pediatr Diabetes. 2019 May;20(3):314-320. doi: 10.1111/pedi.12821. Epub 2019 Feb 10.

Reference Type BACKGROUND
PMID: 30666772 (View on PubMed)

Thalange N, Deeb L, Iotova V, Kawamura T, Klingensmith G, Philotheou A, Silverstein J, Tumini S, Ocampo Francisco AM, Kinduryte O, Danne T. Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2015 May;16(3):164-76. doi: 10.1111/pedi.12263. Epub 2015 Feb 12.

Reference Type RESULT
PMID: 25683037 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2011-003148-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P/44/2010

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1122-4758

Identifier Type: OTHER

Identifier Source: secondary_id

NN1250-3561

Identifier Type: -

Identifier Source: org_study_id

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