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NCT01165684 · ClinicalTrials.gov registry record · Phase 4

Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen

A Phase 4 study, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 4
Development phase
401
Enrollment target

NCT01165684: Completed Phase 4 study, sponsored by Novo Nordisk A/S.

NCT01165684 is a Phase 4 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 401 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01165684, a Phase 4 study, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 4
Development phase
401 participants
Enrollment target

Study Summary

This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.

Primary Outcome

Estimated mean change from baseline in HbA1c after 32 Weeks of treatment

Interventions

  • DRUG insulin aspart
  • DRUG insulin detemir

Trial Details

FieldValue
Enrollment Target 401 participants
Start Date 2010-10
Est. Completion 2012-04
Phase Phase 4
Novo Nordisk A/S

431 total trials

What the finished NCT01165684 record still lists

NCT01165684 is an interventional study that assigns participants to a tested intervention. The registered 401 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% lower).

The record links to 0 conditions, and to 2 interventions - of which insulin aspart is the first listed.

NCT01165684 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01165684 about?

NCT01165684 is a clinical study titled "Efficacy and Safety of Basal-bolus Therapy, Comparing Stepwise Addition of Insulin Aspart Versus Complete Basal-bolus Regimen". This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.

What is the current status of trial NCT01165684?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 401 participants. The study started on 2010-10. Estimated completion is 2012-04.

What interventions are being tested in trial NCT01165684?

The interventions under investigation include: insulin aspart (DRUG), insulin detemir (DRUG).

Who is sponsoring clinical trial NCT01165684?

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 NCT01165684's enrollment target sits among peer trials

401 210th of 2000 higher than 1,790 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01165684, the US trial registry maintained by the National Library of Medicine. NCT01165684 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.