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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04588259
• Collaborator: (none)
• Enrollment: 353
• Locations: 35
• Arms: 2
• Actual Duration (Months): 21.8
• Patients Per Site: 10.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

• Study Type: Interventional
• Actual 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: Oct 9, 2020
• Actual Primary Completion Date: Jul 5, 2022
• Actual Study Completion Date: Aug 5, 2022

Arms and Interventions

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

Primary Outcome Measures

1. Change in glycosylated haemoglobin (HbA1c) [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) [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) [From baseline (week 0) to 16 weeks after randomisation]

   mmol/L

3. Change in fasting plasma glucose (FPG) [From baseline (week 0) to 16 weeks after randomisation]

   mmol/L

4. If a subject achieves HbA1c target: HbA1c below 7.0% [At 16 weeks after randomisation]

   Yes/no

5. If a subject achieves HbA1c target: HbA1c below 7.0% without severe hypoglycaemia [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 [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) [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 [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 [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 [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) [At 16 weeks after randomisation]

    Units

12. Number of treatment emergent adverse events [From week 0 to week 16]

    Count

13. Number of treatment emergent injection site reactions [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 [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) [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 [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Hefei	Anhui	China	230001
2	Novo Nordisk Investigational Site	Hefei	Anhui	China	230061
3	Novo Nordisk Investigational Site	Beijing	Beijing	China	100020
4	Novo Nordisk Investigational Site	Beijing	Beijing	China	100853
5	Novo Nordisk Investigational Site	Beijing	Beijing	China	101200
6	Novo Nordisk Investigational Site	ChongQing	Chongqing	China	404000
7	Novo Nordisk Investigational Site	Guangzhou	Guangdong	China	510120
8	Novo Nordisk Investigational Site	Shantou	Guangdong	China	515065
9	Novo Nordisk Investigational Site	Nanning	Guangxi	China	53007
10	Novo Nordisk Investigational Site	Cangzhou	Hebei	China	061000
11	Novo Nordisk Investigational Site	Hengshui	Hebei	China	053000
12	Novo Nordisk Investigational Site	Shijiazhuang	Hebei	China	050000
13	Novo Nordisk Investigational Site	Tangshan	Hebei	China	063000
14	Novo Nordisk Investigational Site	Yueyang	Hunan	China	414000
15	Novo Nordisk Investigational Site	Huhehaote	Inner Mongolia	China	010020
16	Novo Nordisk Investigational Site	Huhhot	Inner Mongolia	China	010050
17	Novo Nordisk Investigational Site	Changzhou	Jiangsu	China	213003
18	Novo Nordisk Investigational Site	Nanjing	Jiangsu	China	210011
19	Novo Nordisk Investigational Site	Nanjing	Jiangsu	China	210029
20	Novo Nordisk Investigational Site	Nanjing	Jiangsu	China	211106
21	Novo Nordisk Investigational Site	Suzhou	Jiangsu	China	215002
22	Novo Nordisk Investigational Site	Suzhou	Jiangsu	China	215006
23	Novo Nordisk Investigational Site	Zhenjiang	Jiangsu	China	212001
24	Novo Nordisk Investigational Site	Nanchang	Jiangxi	China	330006
25	Novo Nordisk Investigational Site	Changchun	Jilin	China	130021
26	Novo Nordisk Investigational Site	Changchun	Jilin	China	130033
27	Novo Nordisk Investigational Site	Changchun	Jilin	China	130041
28	Novo Nordisk Investigational Site	Xining	Qinghai	China	810007
29	Novo Nordisk Investigational Site	Jinan	Shandong	China	250013
30	Novo Nordisk Investigational Site	Shanghai	Shanghai	China	200072
31	Novo Nordisk Investigational Site	Shanghai	Shanghai	China	200240
32	Novo Nordisk Investigational Site	Shanghai	Shanghai	China	201199
33	Novo Nordisk Investigational Site	Tianjin	Tianjin	China	300052
34	Novo Nordisk Investigational Site	Kunming	Yunnan	China	650032
35	Novo Nordisk Investigational Site	Kunming	Yunnan	China	650101

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency (Dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT04588259
• Other Study ID Numbers: NN1218-4357; U1111-1197-8289
• First Posted: Oct 19, 2020
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination

Study Results

No Results Posted as of Aug 25, 2022