Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes

NCT04588259 | Completed Phase 3 Results

• 2 other identifiers: NN1218-4357U1111-1197-8289
• Study Type: interventional
• Target: 331
• Locations: 2 countries
• Sites: 40

Brief Summary

Fast-acting insulin aspart (faster aspart) will be tested to see how well it works and if it is safe. The study compares 2 medicines for type 1 and type 2 diabetes - faster aspart (a new medicine) and insulin aspart (a medicine doctors can already prescribe). Participants will either get faster aspart or insulin aspart (NovoRapid®) - which treatment is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day: 3 injections 0-2 minutes before breakfast, lunch and dinner and 1 injection at the same time every day. All study medicines are provided in pens. A pen is a tool to inject insulin under the skin.The study will last for about 7 months (30 weeks). Participants will have 11 clinic visits and 17 phone contacts with the study doctor. At 8 clinic visits participants will have blood samples taken. At 3 clinic visits participants cannot eat or drink (water is allowed) 8 hours before the visits - at 2 of these visits participants will be asked to drink a liquid meal and to stay at the clinic for about 5 hours. Participants will fill in a diary the last 3 days before the visits/phone contacts. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])

  Change from baseline (week 0) in HbA1c (%) as evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

  Baseline (week 0), week 16

• Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])

  Change from baseline (week 0) in HbA1c (mmol/mol) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.

  Baseline (week 0), week 16

Secondary Outcomes (27)

• Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test)

  Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)

• Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test)

  Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)

• Change From Baseline in Fasting Plasma Glucose (FPG)

  Baseline (week 0), week 16

• Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) for Mean of the 7-9-7-point Profile

  Baseline (week 0), week 16

• Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal)

  Baseline (week 0), week 16

Study Arms (2)

Faster aspart

EXPERIMENTAL

4 daily injections of faster aspart given with insulin degludec and with or without metformin

Drug: Faster aspart; Drug: Insulin degludec

Insulin aspart

ACTIVE COMPARATOR

4 daily injections of insulin aspart given with insulin degludec and with or without metformin

Drug: Insulin aspart; Drug: Insulin degludec

Interventions

Faster aspart DRUG

Administered s.c. (subcutaneously, under the skin) for 16 weeks

Faster aspart

Insulin aspart DRUG

Administered s.c. (subcutaneously, under the skin) for 16 weeks

Insulin aspart

Insulin degludec DRUG

Administered s.c. (subcutaneously, under the skin) for 16 weeks

Faster aspart; Insulin aspart

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (40)

Anhui Provincial Hospital-Endocrinology

Hefei, Anhui, 230001, China

Location

The First Affiliated Hospital of Anhui Medical University-Endocrinology

Hefei, Anhui, 230061, China

Location

Beijing Chao-Yang Hospital, Capital Medical University-Endocrinology

Beijing, Beijing Municipality, 100020, China

Location

The Fifth Medical Center of PLA General Hospital-Endocrinology

Beijing, Beijing Municipality, 100071, China

Location

The General Hospital of the PLA Rocket Force-Endocrinology

Beijing, Beijing Municipality, 100088, China

Location

Chinese People's Liberation Army General Hospital-Endocrinology

Beijing, Beijing Municipality, 100853, China

Location

Beijing Pinggu Hospital-Endocrinology

Beijing, Beijing Municipality, 101200, China

Location

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, 404000, China

Location

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

Guangzhou, Guangdong, 510120, China

Location

The Second Affiliated Hospital of Shantou University Medical College-Endocrinology

Shantou, Guangdong, 515065, China

Location

The Second Affiliated Hospital of Guangxi Medical University-Endocrinology

Nanning, Guangxi, 530006, China

Location

Cangzhou People's Hospital-Endocrinology

Cangzhou, Hebei, 061000, China

Location

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

Hengshui, Hebei, 053000, China

Location

The Second Hospital of Hebei Medical University-Endocrinology

Shijiazhuang, Hebei, 050000, China

Location

Tangshan Gongren Hospital-Endocrinology

Tangshan, Hebei, 063000, China

Location

Yueyang Central Hospital-Endocrinology

Yueyang, Hunan, 414000, China

Location

Inner Mongolia People's Hospital-Endocrinology

Hohhot, Inner Mongolia, 010020, China

Location

The affiliated Hospital of Inner Mongolia Medical University-Endocrinology

Hohhot, Inner Mongolia, 010050, China

Location

Changzhou No.2 People's Hospital, Yanghu Branch

Changzhou, Jiangsu, 213003, China

Location

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

Nanjing, Jiangsu, 210011, China

Location

Jiangsu Province Hospital-Endocrinology

Nanjing, Jiangsu, 210029, China

Location

Nanjing Jiangning Hospital-Endocrinology

Nanjing, Jiangsu, 211199, China

Location

Suzhou Municipal Hospital-Endocrinology

Suzhou, Jiangsu, 215002, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The Affiliated Hospital of Jiangsu University-Endocrinology

Zhenjiang, Jiangsu, 212001, China

Location

Jiangxi Provincial People's Hospital-Endocrinology

Nanchang, Jiangxi, 330006, China

Location

China-Japan Union Hospital of Jilin University-Endocrinology

Changchun, Jilin, 130033, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

Location

The First Bethune hospital of Jilin University-Endocrinology

Changchun, Jilin, 130061, China

Location

Qinghai Provincial People's Hospital

Xining, Qinghai, 810007, China

Location

Jinan Central Hospital Affiliated to Shandong University

Jinan, Shandong, 250013, China

Location

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

Shanghai, Shanghai Municipality, 200072, China

Location

Shanghai Fifth People's Hospital-Endocrinology

Shanghai, Shanghai Municipality, 200240, China

Location

Central Hospital of Minhang District, Shanghai-Endocrinology

Shanghai, Shanghai Municipality, 201199, China

Location

General Hospital of Tianjin Medical University-Endocrinology

Tianjin, Tianjin Municipality, 300052, China

Location

First Affiliated Hospital of Kunming Medical University-Endocrinology

Kunming, Yunnan, 650032, China

Location

The First People's Hospital of Yunnan Province-Endocrinology

Kunming, Yunnan, 650032, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650101, China

Location

Master Centre for Hong Kong

Kowloon, Hong Kong

Location

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Insulin Aspart; insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Transparency (Dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: October 9, 2020
• Primary Completion: July 5, 2022
• Study Completion: August 5, 2022
• Last Updated: December 4, 2025
• Results First Posted: March 20, 2024

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

HK (2); CN (38)