Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes

NCT ID: NCT03268005

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-19
• Study Completion Date: 2019-01-29

Brief Summary

The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks).

Conditions

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Faster aspart + insulin degludec with or without metformin

Group Type: EXPERIMENTAL

Faster-acting insulin aspart

Intervention Type: DRUG

Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Insulin degludec

Intervention Type: DRUG

Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Metformin

Intervention Type: DRUG

Only participants who took metformin before the study should take metformin tablets, same dose as before the study

NovoRapid/NovoLog + insulin degludec with or without metformin

Group Type: ACTIVE_COMPARATOR

Insulin aspart

Intervention Type: DRUG

Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Insulin degludec

Intervention Type: DRUG

Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Metformin

Intervention Type: DRUG

Only participants who took metformin before the study should take metformin tablets, same dose as before the study

Interventions

Faster-acting insulin aspart

Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Intervention Type: DRUG

Insulin aspart

Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Intervention Type: DRUG

Insulin degludec

Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.

Intervention Type: DRUG

Metformin

Only participants who took metformin before the study should take metformin tablets, same dose as before the study

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: - Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen. - Treated with or without oral antidiabetic drugs including extended release formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1).

Exclusion Criteria

Exclusion Criteria: - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1). - Subjects presently classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1). - Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novo Nordisk Investigational Site

Concord, California, United States

Novo Nordisk Investigational Site

Fresno, California, United States

Novo Nordisk Investigational Site

Fullerton, California, United States

Novo Nordisk Investigational Site

Lancaster, California, United States

Novo Nordisk Investigational Site

Norco, California, United States

Novo Nordisk Investigational Site

Sacramento, California, United States

Novo Nordisk Investigational Site

Ventura, California, United States

Novo Nordisk Investigational Site

Walnut Creek, California, United States

Novo Nordisk Investigational Site

Denver, Colorado, United States

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Golden, Colorado, United States

Novo Nordisk Investigational Site

Waterbury, Connecticut, United States

Novo Nordisk Investigational Site

Boynton Beach, Florida, United States

Novo Nordisk Investigational Site

Bradenton, Florida, United States

Novo Nordisk Investigational Site

Fort Lauderdale, Florida, United States

Novo Nordisk Investigational Site

Miami, Florida, United States

Novo Nordisk Investigational Site

Tampa, Florida, United States

Novo Nordisk Investigational Site

Alpharetta, Georgia, United States

Novo Nordisk Investigational Site

Lawrenceville, Georgia, United States

Novo Nordisk Investigational Site

Roswell, Georgia, United States

Novo Nordisk Investigational Site

Honolulu, Hawaii, United States

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Novo Nordisk Investigational Site

Peoria, Illinois, United States

Novo Nordisk Investigational Site

Springfield, Illinois, United States

Novo Nordisk Investigational Site

Valparaiso, Indiana, United States

Novo Nordisk Investigational Site

West Des Moines, Iowa, United States

Novo Nordisk Investigational Site

Topeka, Kansas, United States

Novo Nordisk Investigational Site

Lexington, Kentucky, United States

Novo Nordisk Investigational Site

Lexington, Kentucky, United States

Novo Nordisk Investigational Site

Rockville, Maryland, United States

Novo Nordisk Investigational Site

Waltham, Massachusetts, United States

Novo Nordisk Investigational Site

Worcester, Massachusetts, United States

Novo Nordisk Investigational Site

Henderson, Nevada, United States

Novo Nordisk Investigational Site

Las Vegas, Nevada, United States

Novo Nordisk Investigational Site

Nashua, New Hampshire, United States

Novo Nordisk Investigational Site

Northport, New York, United States

Novo Nordisk Investigational Site

West Seneca, New York, United States

Novo Nordisk Investigational Site

Asheville, North Carolina, United States

Novo Nordisk Investigational Site

Chapel Hill, North Carolina, United States

Novo Nordisk Investigational Site

Mentor, Ohio, United States

Novo Nordisk Investigational Site

Oklahoma City, Oklahoma, United States

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

Novo Nordisk Investigational Site

Greenville, South Carolina, United States

Novo Nordisk Investigational Site

Chattanooga, Tennessee, United States

Novo Nordisk Investigational Site

Chattanooga, Tennessee, United States

Novo Nordisk Investigational Site

Nashville, Tennessee, United States

Novo Nordisk Investigational Site

Amarillo, Texas, United States

Novo Nordisk Investigational Site

Austin, Texas, United States

Novo Nordisk Investigational Site

Austin, Texas, United States

Novo Nordisk Investigational Site

Beaumont, Texas, United States

Novo Nordisk Investigational Site

Dallas, Texas, United States

Novo Nordisk Investigational Site

Dallas, Texas, United States

Novo Nordisk Investigational Site

Dallas, Texas, United States

Novo Nordisk Investigational Site

Longview, Texas, United States

Novo Nordisk Investigational Site

Pearland, Texas, United States

Novo Nordisk Investigational Site

Round Rock, Texas, United States

Novo Nordisk Investigational Site

Ogden, Utah, United States

Novo Nordisk Investigational Site

Bennington, Vermont, United States

Novo Nordisk Investigational Site

South Burlington, Vermont, United States

Novo Nordisk Investigational Site

Chesapeake, Virginia, United States

Novo Nordisk Investigational Site

Winchester, Virginia, United States

Novo Nordisk Investigational Site

Olympia, Washington, United States

Novo Nordisk Investigational Site

Seattle, Washington, United States

Novo Nordisk Investigational Site

Spokane, Washington, United States

Novo Nordisk Investigational Site

Green Bay, Wisconsin, United States

Novo Nordisk Investigational Site

CABA, , Argentina

Novo Nordisk Investigational Site

CABA, , Argentina

Novo Nordisk Investigational Site

Córdoba, , Argentina

Novo Nordisk Investigational Site

Córdoba, , Argentina

Novo Nordisk Investigational Site

Kozloduy, , Bulgaria

Novo Nordisk Investigational Site

Razgrad, , Bulgaria

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Novo Nordisk Investigational Site

Edmonton, Alberta, Canada

Novo Nordisk Investigational Site

Victoria, British Columbia, Canada

Novo Nordisk Investigational Site

Halifax, Nova Scotia, Canada

Novo Nordisk Investigational Site

Barrie, Ontario, Canada

Novo Nordisk Investigational Site

Concord, Ontario, Canada

Novo Nordisk Investigational Site

Etobicoke, Ontario, Canada

Novo Nordisk Investigational Site

Hamilton, Ontario, Canada

Novo Nordisk Investigational Site

Newmarket, Ontario, Canada

Novo Nordisk Investigational Site

Thunder Bay, Ontario, Canada

Novo Nordisk Investigational Site

Toronto, Ontario, Canada

Novo Nordisk Investigational Site

Montreal, Quebec, Canada

Novo Nordisk Investigational Site

Karlovac, , Croatia

Novo Nordisk Investigational Site

Osijek, , Croatia

Novo Nordisk Investigational Site

Varaždin, , Croatia

Novo Nordisk Investigational Site

Zagreb, , Croatia

Novo Nordisk Investigational Site

Hradec Králové, , Czechia

Novo Nordisk Investigational Site

Pilsen, , Czechia

Novo Nordisk Investigational Site

Pilsen, , Czechia

Novo Nordisk Investigational Site

Trutnov, , Czechia

Novo Nordisk Investigational Site

Dresden, , Germany

Novo Nordisk Investigational Site

Essen, , Germany

Novo Nordisk Investigational Site

Falkensee, , Germany

Novo Nordisk Investigational Site

Lingen, , Germany

Novo Nordisk Investigational Site

Münster, , Germany

Novo Nordisk Investigational Site

Saint Ingbert-Oberwürzbach, , Germany

Novo Nordisk Investigational Site

Schweinfurt, , Germany

Novo Nordisk Investigational Site

Athens, , Greece

Novo Nordisk Investigational Site

Athens, , Greece

Novo Nordisk Investigational Site

Ioannina, , Greece

Novo Nordisk Investigational Site

Larissa, , Greece

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Novo Nordisk Investigational Site

Thessaloniki, , Greece

Novo Nordisk Investigational Site

Catanzaro, , Italy

Novo Nordisk Investigational Site

Chieti, , Italy

Novo Nordisk Investigational Site

Cittadella (PD), , Italy

Novo Nordisk Investigational Site

Milano (MI), , Italy

Novo Nordisk Investigational Site

Olbia, , Italy

Novo Nordisk Investigational Site

Palermo, , Italy

Novo Nordisk Investigational Site

Bialystok, , Poland

Novo Nordisk Investigational Site

Skorzewo, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

Novo Nordisk Investigational Site

Ponce, , Puerto Rico

Novo Nordisk Investigational Site

Baia Mare, Maramureş, Romania

Novo Nordisk Investigational Site

Târgu Mureş, Mureș County, Romania

Novo Nordisk Investigational Site

Timișoara, Timiș County, Romania

Novo Nordisk Investigational Site

Brasov, , Romania

Novo Nordisk Investigational Site

Brasov, , Romania

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Bucharest, , Romania

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Arkhangelsk, , Russia

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Kazan', , Russia

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Moscow, , Russia

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Penza, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Tyumen, , Russia

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Voronezh, , Russia

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Belgrade, , Serbia

Novo Nordisk Investigational Site

Kragujevac, , Serbia

Novo Nordisk Investigational Site

Niš, , Serbia

Novo Nordisk Investigational Site

Novi Sad, , Serbia

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Zaječar, , Serbia

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Košice, , Slovakia

Novo Nordisk Investigational Site

Kysucké Nové Mesto, , Slovakia

Novo Nordisk Investigational Site

Lučenec, , Slovakia

Novo Nordisk Investigational Site

Ľubochňa, , Slovakia

Novo Nordisk Investigational Site

Žilina, , Slovakia

Novo Nordisk Investigational Site

Bucheon-si, , South Korea

Novo Nordisk Investigational Site

Daegu, , South Korea

Novo Nordisk Investigational Site

Seongnam-si, , South Korea

Novo Nordisk Investigational Site

Seoul, , South Korea

Novo Nordisk Investigational Site

Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

Novo Nordisk Investigational Site

Wŏnju, , South Korea

Novo Nordisk Investigational Site

A Coruña, , Spain

Novo Nordisk Investigational Site

Alcobendas, , Spain

Novo Nordisk Investigational Site

Almería, , Spain

Novo Nordisk Investigational Site

Girona, , Spain

Novo Nordisk Investigational Site

Pozuelo de Alarcón, , Spain

Novo Nordisk Investigational Site

Sabadell, , Spain

Novo Nordisk Investigational Site

Seville, , Spain

Novo Nordisk Investigational Site

Seville, , Spain

Novo Nordisk Investigational Site

Dnipro, , Ukraine

Novo Nordisk Investigational Site

Kharkiv, , Ukraine

Novo Nordisk Investigational Site

Kyiv, , Ukraine

Novo Nordisk Investigational Site

Lviv, , Ukraine

Novo Nordisk Investigational Site

Ternopil, , Ukraine

Novo Nordisk Investigational Site

Vinnytsia, , Ukraine

Countries

United States; Argentina; Bulgaria; Canada; Croatia; Czechia; Germany; Greece; Italy; Poland; Puerto Rico; Romania; Russia; Serbia; Slovakia; South Korea; Spain; Ukraine

References

Lane WS, Favaro E, Rathor N, Jang HC, Kjaersgaard MIS, Oviedo A, Rose L, Senior P, Sesti G, Soto Gonzalez A, Franek E. A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (ONSET 9). Diabetes Care. 2020 Aug;43(8):1710-1716. doi: 10.2337/dc19-2232. Epub 2020 Mar 24.

Reference Type: RESULT

PMID: 32209647 (View on PubMed)

Lane W, Favaro E, Jodar E, Kelkar P, Oviedo A, Sivarathinasami R, Senior PA, Sesti G, Franek E. Effective Overall Glycaemic Control with Fast-Acting Insulin Aspart Across Patients with Different Baseline Characteristics: A Post Hoc Analysis of the Onset 9 Trial. Diabetes Ther. 2022 Apr;13(4):761-774. doi: 10.1007/s13300-022-01213-3. Epub 2022 Mar 15.

Reference Type: DERIVED

PMID: 35290624 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1180-0636

Identifier Type: OTHER

Identifier Source: secondary_id

2016-000878-38

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN1218-4113

Identifier Type: -

Identifier Source: org_study_id