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A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus

NCT ID: NCT01835431

Last Updated: 2019-06-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-17

Study Completion Date

2014-11-07

Brief Summary

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This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of insulin degludec/insulin aspart once daily plus insulin aspart for the remaining meals 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/insulin aspart

Intervention Type DRUG

Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.

insulin aspart

Intervention Type DRUG

Administered s.c. with the remaining meals. Dose individually adjusted.

Insulin detemir

Group Type ACTIVE_COMPARATOR

insulin detemir

Intervention Type DRUG

Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing.

insulin aspart

Intervention Type DRUG

Administered s.c. at meal-times. Dose individually adjusted.

Interventions

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insulin degludec/insulin aspart

Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.

Intervention Type DRUG

insulin aspart

Administered s.c. with the remaining meals. Dose individually adjusted.

Intervention Type DRUG

insulin detemir

Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing.

Intervention Type DRUG

insulin aspart

Administered s.c. at meal-times. Dose individually adjusted.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Subjects diagnosed with type 1 diabetes mellitus - HbA1c below or equal to 11.

Exclusion Criteria

0% Exclusion Criteria: - Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator - More than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 (Screening) - Any chronic disorder or significant concomitant disease, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
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

Phoenix, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Tucson, Arizona, United States

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Novo Nordisk Investigational Site

Sacramento, California, United States

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Novo Nordisk Investigational Site

Aurora, Colorado, 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

Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Idaho Falls, Idaho, United States

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Springfield, Illinois, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Worcester, Massachusetts, United States

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Kansas City, Missouri, United States

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Buffalo, New York, United States

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Tulsa, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Brussels, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Vancouver, British Columbia, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Zagreb, , Croatia

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Zagreb, , Croatia

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Olomouc, , Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Hyderabad, Andhra Pradesh, India

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Bangalore, Karnataka, India

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Mumbai, Maharashtra, India

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Mumbai, Maharashtra, India

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New Dehli, New Delhi, India

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Chennai, Tamil Nadu, India

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Beersheba, , Israel

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Haifa, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Ẕerifin, , Israel

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Skopje, , North Macedonia

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Gdansk, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Moscow, , Russia

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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Tomsk, , Russia

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Ufa, , Russia

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Novo Nordisk Investigational Site

Belgrade, , Serbia

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Niš, , Serbia

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Novi Sad, , Serbia

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Ljubljana, , Slovenia

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Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Pretoria, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Mayville, KwaZulu-Natal, South Africa

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Novo Nordisk Investigational Site

Barcelona, , Spain

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Novo Nordisk Investigational Site

Esplugues Llobregat(Barcelona), , Spain

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Novo Nordisk Investigational Site

Leganés, , Spain

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Novo Nordisk Investigational Site

Madrid, , Spain

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Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Countries

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United States Belgium Brazil Canada Croatia Czechia India Israel North Macedonia Poland Russia Serbia Slovenia South Africa Spain

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)

Battelino T, Deeb LC, Ekelund M, Kinduryte O, Klingensmith GJ, Kocova M, Kovarenko M, Shehadeh N. Efficacy and safety of a fixed combination of insulin degludec/insulin aspart in children and adolescents with type 1 diabetes: A randomized trial. Pediatr Diabetes. 2018 Nov;19(7):1263-1270. doi: 10.1111/pedi.12724. Epub 2018 Aug 16.

Reference Type RESULT
PMID: 30014589 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2012-003566-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1133-0958

Identifier Type: OTHER

Identifier Source: secondary_id

PIP no. be confirmed

Identifier Type: OTHER

Identifier Source: secondary_id

NN5401-3816

Identifier Type: -

Identifier Source: org_study_id

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