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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

NCT04588259 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2025-12-04

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2

Interventions

DRUG

Faster aspart

Administered s.c. (subcutaneously, under the skin) for 16 weeks

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (Dept. 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-09
Primary Completion
2022-07-05
Completion
2022-08-05

Countries

  • China
  • Hong Kong

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04588259 on ClinicalTrials.gov