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

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ClinicalTrials.gov Identifier: NCT04588259
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: Faster aspart Drug: Insulin aspart Drug: Insulin degludec Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 353 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Diabetes
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : November 12, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Faster aspart
4 daily injections of faster aspart given with insulin degludec and with or without metformin
 Drug: Faster aspart
Administered s.c. (subcutaneously, under the skin) for 16 weeks

Drug: Insulin degludec
Administered s.c. (subcutaneously, under the skin) for 16 weeks
Active Comparator: Insulin aspart
4 daily injections of insulin aspart given with insulin degludec and with or without metformin
 Drug: Insulin aspart
Administered s.c. (subcutaneously, under the skin) for 16 weeks

Drug: Insulin degludec
Administered s.c. (subcutaneously, under the skin) for 16 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in glycosylated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to week 16 ]
    Percentage points


Secondary Outcome Measures :
  1. Change in 30-minutes, 1-hour, 2-hour and 3-hour post prandial glucose (PPG) increment (meal test) [ Time Frame: From baseline (week 0) to 16 weeks after randomisation ]
    mmol/L

  2. Change in 30-minutes, 1-hour, 2-hour and 3-hour post prandial glucose (PPG) (meal test) [ Time Frame: From baseline (week 0) to 16 weeks after randomisation ]
    mmol/L

  3. Change in fasting plasma glucose (FPG) [ Time Frame: From baseline (week 0) to 16 weeks after randomisation ]
    mmol/L

  4. If a subject achieves HbA1c target: HbA1c below 7.0% [ Time Frame: At 16 weeks after randomisation ]
    Yes/no

  5. If a subject achieves HbA1c target: HbA1c below 7.0% without severe hypoglycaemia [ Time Frame: At 16 weeks after randomisation ]
    Yes/no

  6. Change in 7-9-7-point self-measured plasma glucose (SMPG): Mean of the 7-9-7-point profile [ Time Frame: From baseline (week 0) to 16 weeks after randomisation ]
    mmol/L

  7. Change in 7-9-7-point self-measured plasma glucose (SMPG): 1-hour PPG and PPG increment (mean, breakfast, lunch, main evening meal) [ Time Frame: From baseline (week 0) to 16 weeks after randomisation ]
    mmol/L

  8. Change in 7-9-7-point self-measured plasma glucose (SMPG): Fluctuation in 7-9-7-point profile [ Time Frame: From baseline (week 0) to 16 weeks after randomisation ]
    mmol/L

  9. If a subject achieves PPG target (overall mean of daily PPG measurements in SMPG): Overall PPG (1-hour) equal to or below 7.8 mmol/L [ Time Frame: At 16 weeks after randomisation ]
    Yes/no

  10. If a subject achieves PPG target (overall mean of daily PPG measurements in SMPG): Overall PPG (1-hour) equal to or below 7.8 mmol/L without severe hypoglycaemia [ Time Frame: At 16 weeks after randomisation ]
    Yes/no

  11. Insulin dose (Units/day and Units/kg/day; total basal, total bolus and individual meal insulin dose) [ Time Frame: At 16 weeks after randomisation ]
    Units

  12. Number of treatment emergent adverse events [ Time Frame: From week 0 to week 16 ]
    Count

  13. Number of treatment emergent injection site reactions [ Time Frame: From week 0 to week 16 ]
    Count

  14. Number of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk definition: Overall [ Time Frame: From week 0 to week 16 ]
    Count

  15. Number of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk definition: Daytime and nocturnal hypoglycaemic episodes (00:01-05:59 - both inclusive) [ Time Frame: From week 0 to week 16 ]
    Count

  16. Number of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk (NN) definition [ Time Frame: From week 0 to week 16 ]
    Count. ADA and NN definition of treatment emergent hypoglycaemic episodes: Hypoglycaemic episodes from start of meal until 30 minutes, 1, 2, 4 hours and from 2 hours (exclusive) to 4 hours (inclusive) after start of meal


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588259


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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China, Anhui
Novo Nordisk Investigational Site Recruiting
Hefei, Anhui, China, 230001
Novo Nordisk Investigational Site Suspended
Hefei, Anhui, China, 230061
China, Beijing
Novo Nordisk Investigational Site Recruiting
Beijing, Beijing, China, 100020
Novo Nordisk Investigational Site Recruiting
Beijing, Beijing, China, 100853
Novo Nordisk Investigational Site Recruiting
Beijing, Beijing, China, 101200
China, Chongqing
Novo Nordisk Investigational Site Recruiting
ChongQing, Chongqing, China, 404000
China, Guangdong
Novo Nordisk Investigational Site Recruiting
Guangzhou, Guangdong, China, 510120
Novo Nordisk Investigational Site Recruiting
Shantou, Guangdong, China, 515065
China, Guangxi
Novo Nordisk Investigational Site Recruiting
Nanning, Guangxi, China, 53007
China, Hebei
Novo Nordisk Investigational Site Recruiting
Cangzhou, Hebei, China, 061000
Novo Nordisk Investigational Site Recruiting
Hengshui, Hebei, China, 053000
Novo Nordisk Investigational Site Recruiting
Shijiazhuang, Hebei, China, 050000
Novo Nordisk Investigational Site Suspended
Tangshan, Hebei, China, 063000
China, Hunan
Novo Nordisk Investigational Site Recruiting
Yueyang, Hunan, China, 414000
China, Inner Mongolia
Novo Nordisk Investigational Site Recruiting
Huhehaote, Inner Mongolia, China, 010020
Novo Nordisk Investigational Site Suspended
Huhhot, Inner Mongolia, China, 010050
China, Jiangsu
Novo Nordisk Investigational Site Recruiting
Changzhou, Jiangsu, China, 213003
Novo Nordisk Investigational Site Recruiting
Nanjing, Jiangsu, China, 210011
Novo Nordisk Investigational Site Suspended
Nanjing, Jiangsu, China, 210029
Novo Nordisk Investigational Site Recruiting
Nanjing, Jiangsu, China, 211106
Novo Nordisk Investigational Site Recruiting
Suzhou, Jiangsu, China, 215002
Novo Nordisk Investigational Site Recruiting
Suzhou, Jiangsu, China, 215006
Novo Nordisk Investigational Site Recruiting
Zhenjiang, Jiangsu, China, 212001
China, Jiangxi
Novo Nordisk Investigational Site Recruiting
Nanchang, Jiangxi, China, 330006
China, Jilin
Novo Nordisk Investigational Site Recruiting
Changchun, Jilin, China, 130021
Novo Nordisk Investigational Site Recruiting
Changchun, Jilin, China, 130033
Novo Nordisk Investigational Site Recruiting
Changchun, Jilin, China, 130041
China, Qinghai
Novo Nordisk Investigational Site Recruiting
Xining, Qinghai, China, 810007
China, Shandong
Novo Nordisk Investigational Site Recruiting
Jinan, Shandong, China, 250013
China, Shanghai
Novo Nordisk Investigational Site Recruiting
Shanghai, Shanghai, China, 200072
Novo Nordisk Investigational Site Recruiting
Shanghai, Shanghai, China, 200240
Novo Nordisk Investigational Site Recruiting
Shanghai, Shanghai, China, 201199
China, Tianjin
Novo Nordisk Investigational Site Recruiting
Tianjin, Tianjin, China, 300052
China, Yunnan
Novo Nordisk Investigational Site Suspended
Kunming, Yunnan, China, 650032
Novo Nordisk Investigational Site Recruiting
Kunming, Yunnan, China, 650032
Novo Nordisk Investigational Site Recruiting
Kunming, Yunnan, China, 650101
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (Dept. 1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04588259    
Other Study ID Numbers: NN1218-4357
U1111-1197-8289 ( Other Identifier: World Health Organization (WHO) )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs