Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes

NCT ID: NCT02670915

Last Updated: 2019-06-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

834 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-04

Study Completion Date

2018-03-03

Brief Summary

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This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents 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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Meal-time faster-acting insulin aspart and insulin degludec

Group Type EXPERIMENTAL

Faster-acting insulin aspart

Intervention Type DRUG

For subcutaneous (s.c., under the skin) injection once daily.

insulin degludec

Intervention Type DRUG

For subcutaneous (s.c., under the skin) injection once daily.

Meal-time NovoRapid® (insulin aspart) and insulin degludec

Group Type ACTIVE_COMPARATOR

insulin aspart

Intervention Type DRUG

For subcutaneous (s.c., under the skin) injection once daily.

insulin degludec

Intervention Type DRUG

For subcutaneous (s.c., under the skin) injection once daily.

Post-meal faster-acting insulin aspart and insulin degludec

Group Type EXPERIMENTAL

Faster-acting insulin aspart

Intervention Type DRUG

For subcutaneous (s.c., under the skin) injection once daily.

insulin degludec

Intervention Type DRUG

For subcutaneous (s.c., under the skin) injection once daily.

Interventions

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Faster-acting insulin aspart

For subcutaneous (s.c., under the skin) injection once daily.

Intervention Type DRUG

insulin aspart

For subcutaneous (s.c., under the skin) injection once daily.

Intervention Type DRUG

insulin degludec

For subcutaneous (s.c., under the skin) injection once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Male or female, 1 year above or equal to age below 18 years at the time of signing informed consent and below 18 years at the time of randomisation - Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) - Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or Neutral Protamine Hagedorn (NPH) insulin for at least 90 days prior to the screening visit - HbA1c (glycosylated haemoglobin) below or equal 9.

Exclusion Criteria

5% (80 mmol/mol) analysed by the central laboratory at the screening visit Exclusion Criteria: - More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
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

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Tucson, Arizona, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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Ventura, California, United States

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Aurora, Colorado, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Orlando, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Boise, Idaho, United States

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Idaho Falls, Idaho, United States

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Springfield, Illinois, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Las Vegas, Nevada, United States

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Neptune City, New Jersey, United States

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Buffalo, New York, United States

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Mineola, New York, United States

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Raleigh, North Carolina, United States

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Fargo, North Dakota, United States

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Columbus, Ohio, 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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Pittsburgh, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Salt Lake City, Utah, United States

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Pleven, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Hradec Králové, , Czechia

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Opava, , Czechia

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Ostrava - Poruba, , Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Ústí nad Labem, , Czechia

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Tallinn, , Estonia

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Tartu, , Estonia

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Espoo, , Finland

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OYS, , Finland

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Seinäjoki, , Finland

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Bochum, , Germany

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Freiburg im Breisgau, , Germany

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Hanover, , Germany

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Ludwigshafen, , Germany

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Münster, , Germany

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Neuwied, , Germany

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Oldenburg, , Germany

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Saint Ingbert-Oberwürzbach, , Germany

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Hyderabad, Andhra Pradesh, India

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Hyderabad, Andhra Pradesh, India

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Ahmedabad, Gujarat, India

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Kochi, Kerala, India

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Indore, Madhya Pradesh, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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Chennai, Tamil Nadu, India

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Kolkata, , India

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New Delhi, , India

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Beersheba, , Israel

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Haifa, , Israel

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Holon, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Ẕerifin, , Israel

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Ancona, , Italy

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Catanzaro, , Italy

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Chieti, , Italy

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Napoli, , Italy

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Verona, , Italy

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Amagasaki-shi, Hyogo, , Japan

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Chuo-shi, Yamanashi, , Japan

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Fukuoka, , Japan

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Hiroshima-shi, Hiroshima, , Japan

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Iruma-gun, Saitama, , Japan

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Kitakyushu,Fukuoka, , Japan

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Kitakyushu-shi, Fukuoka, , Japan

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Kobe-shi, Hyogo, , Japan

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Kobe-shi, Hyogo, , Japan

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Kochi-shi, Kochi, , Japan

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Kofu, Yamanashi, , Japan

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Kumamoto-shi, Kumamoto, , Japan

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Kure-shi, Hiroshima, , Japan

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Kyoto, , Japan

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Maebashi-shi, Gunma, , Japan

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Matsumoto-shi, Nagano,, , Japan

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Matsuyama-shi, Ehime, , Japan

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Musashino-shi, Tokyo, , Japan

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Niigata-shi, Niigata, , Japan

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Niigata-shi, Niigata, , Japan

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Okayama Kita-ku, Okayama, , Japan

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Okayama-shi, Okayama, , Japan

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Okayama-shi, Okayama, , Japan

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Osaka-shi, Osaka, , Japan

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Ota-shi, Gunma, , Japan

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Otsu-shi, Shiga, , Japan

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Saga-shi, Saga, , Japan

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Sendai-shi, Miyagi, , Japan

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Suzaka-shi ,Nagano, , Japan

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Tochigi, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tsu-shi, Mie, , Japan

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Yokohama-shi, Kanagawa, , Japan

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Yokosuka-shi, Kanagawa, , Japan

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Riga, , Latvia

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Kaunas, , Lithuania

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Gdansk, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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San Juan, , Puerto Rico

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Kazan', , Russia

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Moscow, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Saratov, , Russia

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Tomsk, , Russia

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Ufa, , Russia

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Belgrade, , Serbia

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Belgrade, , Serbia

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Niš, , Serbia

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Novi Sad, , Serbia

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Adana, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Samsun, , Turkey (Türkiye)

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Dnipro, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhzhia, , Ukraine

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Countries

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United States Bulgaria Czechia Estonia Finland Germany India Israel Italy Japan Latvia Lithuania Poland Puerto Rico Russia Serbia Turkey (Türkiye) Ukraine

References

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Bode BW, Iotova V, Kovarenko M, Laffel LM, Rao PV, Deenadayalan S, Ekelund M, Larsen SF, Danne T. Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial. Diabetes Care. 2019 Jul;42(7):1255-1262. doi: 10.2337/dc19-0009. Epub 2019 May 10.

Reference Type BACKGROUND
PMID: 31076415 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2014-002568-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1158-1170

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-163248

Identifier Type: OTHER

Identifier Source: secondary_id

NN1218-4101

Identifier Type: -

Identifier Source: org_study_id

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