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

NCT ID: NCT02500706

Last Updated: 2019-06-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-04

Study Completion Date

2017-08-16

Brief Summary

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This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults 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

DOUBLE

Participants Investigators

Study Groups

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Mealtime faster-acting insulin aspart and insulin degludec

Group Type EXPERIMENTAL

Faster-acting insulin aspart

Intervention Type DRUG

Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.

insulin degludec

Intervention Type DRUG

Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted

Mealtime NovoRapid® and insulin degludec

Group Type ACTIVE_COMPARATOR

insulin aspart

Intervention Type DRUG

Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal.

insulin degludec

Intervention Type DRUG

Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted

Postmeal faster-acting insulin aspart and insulin degludec

Group Type EXPERIMENTAL

Faster-acting insulin aspart

Intervention Type DRUG

Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.

insulin degludec

Intervention Type DRUG

Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted

Interventions

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Faster-acting insulin aspart

Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.

Intervention Type DRUG

insulin aspart

Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal.

Intervention Type DRUG

insulin degludec

Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Male or female, age greater than or equal to 18 years ( for Japan and Taiwan: age greater than or equal to 20 years) at the time of signing informed consent - Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index less than or equal to 35.

Exclusion Criteria

0 kg/m\^2 Exclusion Criteria: - Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack - Subjects presently classified as being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (Visit 1) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of three months before screening (Visit 1)
Minimum Eligible Age

18 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

Locations

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Novo Nordisk Investigational Site

Tucson, Arizona, United States

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Concord, California, United States

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Encino, California, United States

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Escondido, California, United States

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Fresno, California, United States

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Fullerton, California, United States

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Huntington Beach, California, United States

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Monterey, California, United States

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Newport Beach, California, United States

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Santa Barbara, California, United States

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Walnut Creek, California, United States

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Denver, Colorado, United States

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Golden, Colorado, United States

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Palm Harbor, Florida, United States

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Tampa, Florida, United States

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Roswell, Georgia, United States

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Idaho Falls, Idaho, United States

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Topeka, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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Flint, Michigan, United States

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Kalamazoo, Michigan, United States

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Minneapolis, Minnesota, United States

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Jefferson City, Missouri, United States

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Las Vegas, Nevada, United States

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Nashua, New Hampshire, United States

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Hamilton, New Jersey, United States

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Lawrenceville, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Rochester, New York, United States

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Chapel Hill, North Carolina, United States

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Greenville, North Carolina, United States

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Wilmington, North Carolina, United States

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Bend, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Chattanooga, Tennessee, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Mesquite, Texas, United States

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Round Rock, Texas, United States

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Murray, Utah, United States

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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Federal Way, Washington, United States

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Renton, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Graz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Dimitrovgrad, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Calgary, Alberta, Canada

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Halifax, Nova Scotia, Canada

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Concord, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, , Canada

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Québec, , Canada

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Berlin, , Germany

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Berlin, , Germany

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Dresden, , Germany

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Falkensee, , Germany

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Lingen, , Germany

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Münster, , Germany

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Neuwied, , Germany

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Schweinfurt, , Germany

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Hyderabad, Andhra Pradesh, India

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Visakhapatnam, Andhra Pradesh, India

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Ahmedabad, Gujarat, India

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Ahmedabad, Gujarat, India

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Rohtak, Haryana, India

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Kozhikode, Kerala, India

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Indore, Madhya Pradesh, India

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Indore, Madhya Pradesh, India

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Pune, Maharashtra, India

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Bhubaneswar, Odisha, India

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Chennai, Tamil Nadu, India

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Chennai, Tamil Nadu, India

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Vellore, Tamil Nadu, India

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Chandigarh, , India

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New Dehli, , India

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New Delhi, , India

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Pune, , India

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Haifa, , Israel

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Holon, , Israel

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Jerusalem, , Israel

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Jerusalem, , Israel

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Petah Tikva, , Israel

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Rishon LeZiyyon, , Israel

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Ancona, , Italy

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Bergamo, , Italy

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Catanzaro, , Italy

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Milan, , Italy

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Rome, , Italy

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Sesto San Giovanni (MI), , Italy

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Amagasaki-shi, Hyogo, , Japan

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Chuo-ku, Tokyo, , Japan

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Ebina-shi, Kanagawa, , Japan

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Fukuoka, , Japan

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Fukushima, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Ibaraki, , Japan

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Ibaraki, , Japan

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Izumisano, , Japan

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Kanagawa, , Japan

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Kobe-shi, Hyogo, , Japan

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Kumamoto, , Japan

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Matsumoto-shi, Nagano, , Japan

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Mito-shi, Ibaraki, , Japan

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Miyazaki, , Japan

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Osaka, , Japan

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Osaka-shi, Osaka, , Japan

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Ota-ku, Tokyo, , Japan

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Ōita, , Japan

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Sapporo-shi, Hokkaido, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Ponce, , Puerto Rico

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Barnaul, , Russia

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Kazan', , Russia

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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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Novosibirsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Tyumen, , Russia

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Belgrade, , Serbia

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Countries

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United States Austria Bulgaria Canada Germany India Israel Italy Japan Puerto Rico Russia Serbia Taiwan

References

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Rose L, Kadowaki T, Pieber TR, Buchholtz K, Ekelund M, Gorst-Rasmussen A, Philis-Tsimikas A. Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials. Diabetes Ther. 2019 Jun;10(3):1029-1041. doi: 10.1007/s13300-019-0608-4. Epub 2019 Apr 4.

Reference Type BACKGROUND
PMID: 30949906 (View on PubMed)

Buse JB, Carlson AL, Komatsu M, Mosenzon O, Rose L, Liang B, Buchholtz K, Horio H, Kadowaki T. Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial. Diabetes Obes Metab. 2018 Dec;20(12):2885-2893. doi: 10.1111/dom.13545. Epub 2018 Oct 10.

Reference Type RESULT
PMID: 30259644 (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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2015-001047-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1167-9495

Identifier Type: OTHER

Identifier Source: secondary_id

NN1218-4131

Identifier Type: -

Identifier Source: org_study_id

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