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NCT03268005 · ClinicalTrials.gov registry record · Phase 3

Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes

A Phase 3 study, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
1,264
Enrollment target

NCT03268005: Completed Phase 3 study, sponsored by Novo Nordisk A/S.

NCT03268005 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 1,264 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03268005, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
1,264 participants
Enrollment target

Study Summary

The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks).

Primary Outcome

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period was from date of randomisation and until last trial-related participant-site contact.

Interventions

  • DRUG Metformin
  • DRUG Insulin aspart
  • DRUG Faster-acting insulin aspart
  • DRUG Insulin degludec

Trial Details

FieldValue
Enrollment Target 1,264 participants
Start Date 2017-09-19
Est. Completion 2019-01-29
Phase Phase 3
Novo Nordisk A/S

431 total trials

What the finished NCT03268005 record still lists

NCT03268005 is an interventional study that assigns participants to a tested intervention. Its 1,264 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% higher).

The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.

NCT03268005 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03268005 about?

NCT03268005 is a clinical study titled "Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes". The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin a...

What is the current status of trial NCT03268005?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,264 participants. The study started on 2017-09-19. Estimated completion is 2019-01-29.

What interventions are being tested in trial NCT03268005?

The interventions under investigation include: Metformin (DRUG), Insulin aspart (DRUG), Faster-acting insulin aspart (DRUG), Insulin degludec (DRUG).

Who is sponsoring clinical trial NCT03268005?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03268005's enrollment target sits among peer trials

1,264 203rd of 2000 higher than 1,797 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03268005, the US trial registry maintained by the National Library of Medicine. NCT03268005 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.