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New fast-acting insulin tested against standard in diabetes trial

NCT ID NCT04588259

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new fast-acting insulin (faster aspart) against a standard insulin (NovoRapid) in 331 adults with type 1 or type 2 diabetes. Both were taken with a long-acting insulin (insulin degludec) for 16 weeks. The goal was to see if the new insulin works better at controlling blood sugar, especially after meals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fast-acting insulin aspart
What this could lead to
If it works, this could offer a faster-acting insulin option for better blood sugar control after meals.
What could go wrong
This is a completed Phase 3 trial, but results may not show meaningful improvement over existing insulins. Risks include low blood sugar and injection site reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

331 people

The number who actually took part.

Started

Oct 2020

Finished

Aug 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female, age above or equal to 18 years at the time of signing informed consent * Diagnosed with Diabetes Mellitus, Type 1 (T1DM) at least or equal to 1 year prior to screening or diagnosed with Diabetes Mellitus, Type 2 (T2DM) at least or equal to 5 years prior to screening * Treated with a basal-bolus insulin regimen or a premix insulin regimen at least or equal to 1 year prior to screening. Insulin regimen must be unchanged within 60 days prior to screening. A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin taken with meals at least thrice daily. A premix insulin regimen is defined as premix insulin twice or thrice daily * For subjects with T1DM: not treated with any oral anti-diabetes drugs (OADs) for at least 90 days prior to screening. For subjects with T2DM: not treated with any OADs or treated with 1-2 OADs within 90 days prior to screening. Allowed OADs are metformin, alpha-glucosidase inhibitor, sodium-glucose co-transporter-2 inhibitors (SGLT2i) and dipeptidyl peptidase-4 inhibitors (DPP4i). Change in OAD and dose prior to screening is allowed. * HbA1c 7.5-9.5% (both inclusive) as assessed by central laboratory at screening Exclusion Criteria: * Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 180 days prior to the day of screening * 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 * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening * 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)

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus type 1 diabetes mellitus 1 type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2 Diabetes mellitus, type 1

Contacts and locations

Locations

  • Anhui Provincial Hospital-Endocrinology

    Hefei, Anhui, 230001, China

  • Beijing Chao-Yang Hospital, Capital Medical University-Endocrinology

    Beijing, Beijing Municipality, 100020, China

  • Beijing Pinggu Hospital-Endocrinology

    Beijing, Beijing Municipality, 101200, China

  • Cangzhou People's Hospital-Endocrinology

    Cangzhou, Hebei, 061000, China

  • Central Hospital of Minhang District, Shanghai-Endocrinology

    Shanghai, Shanghai Municipality, 201199, China

  • Changzhou No.2 People's Hospital, Yanghu Branch

    Changzhou, Jiangsu, 213003, China

  • China-Japan Union Hospital of Jilin University-Endocrinology

    Changchun, Jilin, 130033, China

  • Chinese People's Liberation Army General Hospital-Endocrinology

    Beijing, Beijing Municipality, 100853, China

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000, China

  • First Affiliated Hospital of Kunming Medical University-Endocrinology

    Kunming, Yunnan, 650032, China

  • General Hospital of Tianjin Medical University-Endocrinology

    Tianjin, Tianjin Municipality, 300052, China

  • Hengshui People's Hospital (Harrison International Peace Hospital)-Endocrinology

    Hengshui, Hebei, 053000, China

  • Inner Mongolia People's Hospital-Endocrinology

    Hohhot, Inner Mongolia, 010020, China

  • Jiangsu Province Hospital-Endocrinology

    Nanjing, Jiangsu, 210029, China

  • Jiangxi Provincial People's Hospital-Endocrinology

    Nanchang, Jiangxi, 330006, China

  • Jinan Central Hospital Affiliated to Shandong University

    Jinan, Shandong, 250013, China

  • Master Centre for Hong Kong

    Kowloon, Hong Kong

  • Nanjing Jiangning Hospital-Endocrinology

    Nanjing, Jiangsu, 211199, China

  • Prince of Wales Hospital

    Shatin, New Territories, Hong Kong

  • Qinghai Provincial People's Hospital

    Xining, Qinghai, 810007, China

  • Shanghai Fifth People's Hospital-Endocrinology

    Shanghai, Shanghai Municipality, 200240, China

  • Shanghai Tenth People's Hospital (Tenth People's of Tongji University)-Endocrinology

    Shanghai, Shanghai Municipality, 200072, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120, China

  • Suzhou Municipal Hospital-Endocrinology

    Suzhou, Jiangsu, 215002, China

  • Tangshan Gongren Hospital-Endocrinology

    Tangshan, Hebei, 063000, China

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang, Jiangsu, 212001, China

  • The Fifth Medical Center of PLA General Hospital-Endocrinology

    Beijing, Beijing Municipality, 100071, China

  • The First Affiliated Hospital of Anhui Medical University-Endocrinology

    Hefei, Anhui, 230061, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The First Bethune hospital of Jilin University-Endocrinology

    Changchun, Jilin, 130061, China

  • The First People's Hospital of Yunnan Province-Endocrinology

    Kunming, Yunnan, 650032, China

  • The General Hospital of the PLA Rocket Force-Endocrinology

    Beijing, Beijing Municipality, 100088, China

  • The Second Affiliated Hospital of Guangxi Medical University-Endocrinology

    Nanning, Guangxi, 530006, China

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650101, China

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing, Jiangsu, 210011, China

  • The Second Affiliated Hospital of Shantou University Medical College-Endocrinology

    Shantou, Guangdong, 515065, China

  • The Second Hospital of Hebei Medical University-Endocrinology

    Shijiazhuang, Hebei, 050000, China

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041, China

  • The affiliated Hospital of Inner Mongolia Medical University-Endocrinology

    Hohhot, Inner Mongolia, 010050, China

  • Yueyang Central Hospital-Endocrinology

    Yueyang, Hunan, 414000, China

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