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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

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Faster aspart
Insulin aspart
Insulin degludec
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Faster aspart

Insulin aspart

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in glycosylated haemoglobin (HbA1c)
Percentage points

Secondary Outcome Measures

Change in 30-minutes, 1-hour, 2-hour and 3-hour post prandial glucose (PPG) increment (meal test)
mmol/L
Change in 30-minutes, 1-hour, 2-hour and 3-hour post prandial glucose (PPG) (meal test)
mmol/L
Change in fasting plasma glucose (FPG)
mmol/L
If a subject achieves HbA1c target: HbA1c below 7.0%
Yes/no
If a subject achieves HbA1c target: HbA1c below 7.0% without severe hypoglycaemia
Yes/no
Change in 7-9-7-point self-measured plasma glucose (SMPG): Mean of the 7-9-7-point profile
mmol/L
Change in 7-9-7-point self-measured plasma glucose (SMPG): 1-hour PPG and PPG increment (mean, breakfast, lunch, main evening meal)
mmol/L
Change in 7-9-7-point self-measured plasma glucose (SMPG): Fluctuation in 7-9-7-point profile
mmol/L
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
Yes/no
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
Yes/no
Insulin dose (Units/day and Units/kg/day; total basal, total bolus and individual meal insulin dose)
Units
Number of treatment emergent adverse events
Count
Number of treatment emergent injection site reactions
Count
Number of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk definition: Overall
Count
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)
Count
Number of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk (NN) definition
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

Full Information

First Posted
October 9, 2020
Last Updated
November 3, 2022
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04588259
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
July 5, 2022 (Actual)
Study Completion Date
August 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Faster aspart
Arm Type
Experimental
Arm Description
4 daily injections of faster aspart given with insulin degludec and with or without metformin
Arm Title
Insulin aspart
Arm Type
Active Comparator
Arm Description
4 daily injections of insulin aspart given with insulin degludec and with or without metformin
Intervention Type
Drug
Intervention Name(s)
Faster aspart
Intervention Description
Administered s.c. (subcutaneously, under the skin) for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Insulin aspart
Intervention Description
Administered s.c. (subcutaneously, under the skin) for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Insulin degludec
Intervention Description
Administered s.c. (subcutaneously, under the skin) for 16 weeks
Primary Outcome Measure Information:
Title
Change in glycosylated haemoglobin (HbA1c)
Description
Percentage points
Time Frame
From baseline (week 0) to week 16
Secondary Outcome Measure Information:
Title
Change in 30-minutes, 1-hour, 2-hour and 3-hour post prandial glucose (PPG) increment (meal test)
Description
mmol/L
Time Frame
From baseline (week 0) to 16 weeks after randomisation
Title
Change in 30-minutes, 1-hour, 2-hour and 3-hour post prandial glucose (PPG) (meal test)
Description
mmol/L
Time Frame
From baseline (week 0) to 16 weeks after randomisation
Title
Change in fasting plasma glucose (FPG)
Description
mmol/L
Time Frame
From baseline (week 0) to 16 weeks after randomisation
Title
If a subject achieves HbA1c target: HbA1c below 7.0%
Description
Yes/no
Time Frame
At 16 weeks after randomisation
Title
If a subject achieves HbA1c target: HbA1c below 7.0% without severe hypoglycaemia
Description
Yes/no
Time Frame
At 16 weeks after randomisation
Title
Change in 7-9-7-point self-measured plasma glucose (SMPG): Mean of the 7-9-7-point profile
Description
mmol/L
Time Frame
From baseline (week 0) to 16 weeks after randomisation
Title
Change in 7-9-7-point self-measured plasma glucose (SMPG): 1-hour PPG and PPG increment (mean, breakfast, lunch, main evening meal)
Description
mmol/L
Time Frame
From baseline (week 0) to 16 weeks after randomisation
Title
Change in 7-9-7-point self-measured plasma glucose (SMPG): Fluctuation in 7-9-7-point profile
Description
mmol/L
Time Frame
From baseline (week 0) to 16 weeks after randomisation
Title
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
Description
Yes/no
Time Frame
At 16 weeks after randomisation
Title
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
Description
Yes/no
Time Frame
At 16 weeks after randomisation
Title
Insulin dose (Units/day and Units/kg/day; total basal, total bolus and individual meal insulin dose)
Description
Units
Time Frame
At 16 weeks after randomisation
Title
Number of treatment emergent adverse events
Description
Count
Time Frame
From week 0 to week 16
Title
Number of treatment emergent injection site reactions
Description
Count
Time Frame
From week 0 to week 16
Title
Number of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk definition: Overall
Description
Count
Time Frame
From week 0 to week 16
Title
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)
Description
Count
Time Frame
From week 0 to week 16
Title
Number of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk (NN) definition
Description
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
Time Frame
From week 0 to week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (Dept. 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230061
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101200
Country
China
Facility Name
Novo Nordisk Investigational Site
City
ChongQing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515065
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
53007
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Cangzhou
State/Province
Hebei
ZIP/Postal Code
061000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Hengshui
State/Province
Hebei
ZIP/Postal Code
053000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Yueyang
State/Province
Hunan
ZIP/Postal Code
414000
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Huhehaote
State/Province
Inner Mongolia
ZIP/Postal Code
010020
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Huhhot
State/Province
Inner Mongolia
ZIP/Postal Code
010050
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211199
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215002
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130033
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Xining
State/Province
Qinghai
ZIP/Postal Code
810007
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200240
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201199
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650101
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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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