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

  • STATUS
    Recruiting
  • End date
    Nov 12, 2022
  • participants needed
    353
  • sponsor
    Novo Nordisk A/S
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Updated on 3 March 2021
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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.

Details
Condition NIDDM, Insulin dependent diabetes mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Mellitus Type 2, type 1 diabetes mellitus, type 2 diabetes mellitus, type 1 diabetes, diabetes type 1, diabetes mellitus type 1, insulin-dependent diabetes, iddm, type i diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Insulin Aspart, insulin degludec, Faster aspart
Clinical Study IdentifierNCT04588259
SponsorNovo Nordisk A/S
Last Modified on3 March 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Diabetes Mellitus, Type 2 or Insulin dependent diabetes mellitus or Diabetes Mellitus, Type 1 or Diabetes Mellitus Type 2 or NIDDM?
Do you have any of these conditions: type 2 diabetes mellitus or Insulin dependent diabetes mellitus or type 1 diabetes mellitus or type ii diabetes or Diabetes Mellitus Type 2 or diabete...?
Do you have any of these conditions: Diabetes Mellitus, Type 2 or diabetes type 2 or Diabetes Mellitus Type 2 or insulin-dependent diabetes or Diabetes Mellitus, Type 1 or Insulin depende...?
Do you have any of these conditions: type 1 diabetes mellitus or noninsulin-dependent diabetes mellitus or diabetes type 2 or NIDDM or type ii diabetes or Diabetes Mellitus, Type 2 or typ...?
Do you have any of these conditions: Diabetes Mellitus, Type 1 or Diabetes Mellitus, Type 2 or Diabetes Mellitus Type 2 or type 1 diabetes or insulin-dependent diabetes or diabetes type 2...?
Do you have any of these conditions: Insulin dependent diabetes mellitus or NIDDM or Diabetes Mellitus, Type 1 or type 2 diabetes mellitus or diabetes type 1 or diabetes mellitus type 1 o...?
Do you have any of these conditions: Diabetes Mellitus Type 2 or type 1 diabetes or type ii diabetes or diabetes type 2 or type 2 diabetes or Diabetes Mellitus, Type 1 or type i diabetes ...?
Do you have any of these conditions: diabetes mellitus type 1 or Diabetes Mellitus Type 2 or type 1 diabetes mellitus or type 1 diabetes or type ii diabetes or type i diabetes mellitus or...?
Do you have any of these conditions: Diabetes Mellitus, Type 2 or type i diabetes mellitus or type 2 diabetes mellitus or diabetes type 1 or iddm or Diabetes Mellitus Type 2 or diabetes t...?
Do you have any of these conditions: type i diabetes mellitus or iddm or insulin-dependent diabetes or diabetes mellitus type 1 or Diabetes Mellitus, Type 2 or diabetes type 1 or NIDDM or...?
Do you have any of these conditions: type i diabetes mellitus or Diabetes Mellitus, Type 1 or type ii diabetes or insulin-dependent diabetes or Diabetes Mellitus Type 2 or Insulin depende...?
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)
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