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
Recruiting
CT.gov ID
NCT04588259
Collaborator
(none)
353
Enrollment
36
Locations
2
Arms
25.1
Anticipated Duration (Months)
9.8
Patients Per Site
0.4
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
  • Drug: Faster aspart
  • Drug: Insulin aspart
  • Drug: Insulin degludec
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Oct 15, 2022
Anticipated Study Completion Date :
Nov 12, 2022

Arms and Interventions

ArmIntervention/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

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteHefeiAnhuiChina230001
2Novo Nordisk Investigational SiteHefeiAnhuiChina230061
3Novo Nordisk Investigational SiteBeijingBeijingChina100020
4Novo Nordisk Investigational SiteBeijingBeijingChina100853
5Novo Nordisk Investigational SiteBeijingBeijingChina101200
6Novo Nordisk Investigational SiteChongQingChongqingChina404000
7Novo Nordisk Investigational SiteGuangzhouGuangdongChina510120
8Novo Nordisk Investigational SiteShantouGuangdongChina515065
9Novo Nordisk Investigational SiteNanningGuangxiChina53007
10Novo Nordisk Investigational SiteCangzhouHebeiChina061000
11Novo Nordisk Investigational SiteHengshuiHebeiChina053000
12Novo Nordisk Investigational SiteShijiazhuangHebeiChina050000
13Novo Nordisk Investigational SiteTangshanHebeiChina063000
14Novo Nordisk Investigational SiteYueyangHunanChina414000
15Novo Nordisk Investigational SiteHuhehaoteInner MongoliaChina010020
16Novo Nordisk Investigational SiteHuhhotInner MongoliaChina010050
17Novo Nordisk Investigational SiteChangzhouJiangsuChina213003
18Novo Nordisk Investigational SiteNanjingJiangsuChina210011
19Novo Nordisk Investigational SiteNanjingJiangsuChina210029
20Novo Nordisk Investigational SiteNanjingJiangsuChina211106
21Novo Nordisk Investigational SiteSuzhouJiangsuChina215002
22Novo Nordisk Investigational SiteSuzhouJiangsuChina215006
23Novo Nordisk Investigational SiteZhenjiangJiangsuChina212001
24Novo Nordisk Investigational SiteNanchangJiangxiChina330006
25Novo Nordisk Investigational SiteChangchunJilinChina130021
26Novo Nordisk Investigational SiteChangchunJilinChina130033
27Novo Nordisk Investigational SiteChangchunJilinChina130041
28Novo Nordisk Investigational SiteXiningQinghaiChina810007
29Novo Nordisk Investigational SiteJinanShandongChina250013
30Novo Nordisk Investigational SiteShanghaiShanghaiChina200072
31Novo Nordisk Investigational SiteShanghaiShanghaiChina200240
32Novo Nordisk Investigational SiteShanghaiShanghaiChina201199
33Novo Nordisk Investigational SiteTianjinTianjinChina300052
34Novo Nordisk Investigational SiteKunmingYunnanChina650032
35Novo Nordisk Investigational SiteKunmingYunnanChina650032
36Novo Nordisk Investigational SiteKunmingYunnanChina650101

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:
Nov 16, 2021
Last Verified:
Nov 1, 2021
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:

Study Results

No Results Posted as of Nov 16, 2021