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
Study ID
NCT04588259
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Faster aspart — DRUG
    Administered s.c. (subcutaneously, under the skin) for 16 weeks
  • Insulin aspart — DRUG
    Administered s.c. (subcutaneously, under the skin) for 16 weeks
  • Insulin degludec — DRUG
    Administered s.c. (subcutaneously, under the skin) for 16 weeks

Study Details

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.

Key Dates

Start date
Oct 9, 2020
Status verified
Nov 2025
Primary completion
Jul 5, 2022
Completion
Aug 5, 2022

Study Design

Enrollment
331 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Faster aspart
    4 daily injections of faster aspart given with insulin degludec and with or without metformin
  • Active Comparator: Insulin aspart
    4 daily injections of insulin aspart given with insulin degludec and with or without metformin

Primary Outcome Measure

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%]) [ Time Frame: Baseline (week 0), week 16 ]

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