Clinical trial NCT04588259: Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 331
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])
timeFrame: Baseline (week 0), week 16
measure: Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])
timeFrame: Baseline (week 0), week 16
Secondary outcomes:
measure: Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test)
timeFrame: Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)
measure: Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test)
timeFrame: Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
timeFrame: Baseline (week 0), week 16
measure: Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) for Mean of the 7-9-7-point Profile
timeFrame: Baseline (week 0), week 16
measure: Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal)
timeFrame: Baseline (week 0), week 16
measure: Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)
timeFrame: Baseline (week 0), week 16
measure: Change From Baseline in 7-9-7-point SMPG for Fluctuation in 7-9-7-point Profile: Ratio to Baseline
timeFrame: Baseline (week 0), week 16
measure: Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No)
timeFrame: At week 16
measure: Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No)
timeFrame: At week 16
measure: Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L (Yes/No)
timeFrame: At week 16
measure: Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L Without Severe Hypoglycaemia (Yes/No)
timeFrame: At week 16
measure: Insulin Dose (Units/Day): Total Basal
timeFrame: At week 16
measure: Insulin Dose (Units/Day): Total Bolus
timeFrame: At week 16
measure: Insulin Dose (Units/Day): Individual Meal Insulin Dose
timeFrame: At week 16
measure: Insulin Dose (Units/kg/Day): Total Basal
timeFrame: At week 16
measure: Insulin Dose (Units/kg/Day): Total Bolus
timeFrame: At week 16
measure: Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose
timeFrame: At week 16
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to 16 weeks after randomisation
measure: Number of Treatment Emergent Injection Site Reactions
timeFrame: From baseline (week 0) to 16 weeks after randomisation
measure: Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall
timeFrame: From baseline (week 0) to 16 weeks after randomisation
measure: Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Day Time Hypoglycaemic Episodes (00:01-05:59 - Both Inclusive)
timeFrame: From baseline (week 0) to 16 weeks after randomisation
measure: Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Both Inclusive)
timeFrame: From baseline (week 0) to 16 weeks after randomisation
measure: Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 30 Minutes
timeFrame: From baseline (week 0) to 16 weeks after randomisation
measure: Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 1 Hour
timeFrame: From baseline (week 0) to 16 weeks after randomisation
measure: Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 2 Hours
timeFrame: From baseline (week 0) to 16 weeks after randomisation
measure: Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 4 Hours
timeFrame: From baseline (week 0) to 16 weeks after randomisation
measure: Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal
timeFrame: From baseline (week 0) to 16 weeks after randomisation
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital-Endocrinology
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Chao-yang Hospital, Capital Medical University-Endocrinology
state: Beijing
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital-Endocrinology
state: Beijing
city: Beijing
country: China
facility: Beijing Pinggu Hospital-Endocrinology
state: Beijing
city: ChongQing
country: China
facility: Chongqing University Three Gorges Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy
state: Guangdong
city: Shantou
country: China
facility: The Second Affiliated Hospital of Shantou University Medical College-Endocrinology
state: Guangdong
city: Nanning
country: China
facility: The Second Affiliated Hospital of Guangxi Medical University-Endocrinology
state: Guangxi
city: Cangzhou
country: China
facility: Cangzhou People's Hospital-Endocrinology
state: Hebei
city: Hengshui
country: China
facility: Harrison International Peace Hospital-Endocrinology
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University-Endocrinology
state: Hebei
city: Tangshan
country: China
facility: Tangshan Gongren Hospital
state: Hebei
city: Yueyang
country: China
facility: Yueyang Central Hospital-Endocrinology
state: Hunan
city: Huhehaote
country: China
facility: Inner Mongolia People's Hospital-Endocrinology
state: Inner Mongolia
city: Huhhot
country: China
facility: The affiliated hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital, Yanghu Branch
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Jiangning Hospital-Endocrinology
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital-Endocrinology
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Zhenjiang
country: China
facility: The Affiliated Hospital of Jiangsu University-Endocrinology
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital-Endocrinology
state: Jiangxi
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University-Endocrinology
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The First Bethune hospital of Jilin University-Endocrinology
state: Jilin
city: Xining
country: China
facility: Qinghai Provincial People's Hospital
state: Qinghai
city: Ji'nan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Tenth People's Hsopital (Tenth People's of Tongji University)-Endocrinology
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital-Endocrinology
state: Shanghai
city: Shanghai
country: China
facility: Central Hospital of Minhang District-Endocrinology
state: Shanghai
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University-Endocrinology
state: Tianjin
city: Kunming
country: China
facility: First Affiated Hospital of Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province-Endocrinology
state: Yunnan
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (Dept. 1452)
role: STUDY_DIRECTOR
References: