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NCT00978627 · ClinicalTrials.gov registry record · Phase 3

Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes

A Phase 3 study of Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
548
Enrollment target
20
Study locations

NCT00978627: Completed Phase 3 study of Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S.

NCT00978627 is a Phase 3 study of Diabetes and Diabetes Mellitus, Type 1 that has completed, run by Novo Nordisk A/S. The registered enrollment target is 548 participants, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00978627, a Phase 3 study of Diabetes and Diabetes Mellitus, Type 1, has completed, sponsored by Novo Nordisk A/S.

COMPLETED
Registry status
Phase 3
Development phase
548 participants
Enrollment target
20
Study locations

Study Summary

This trial is conducted in Europe, Oceania, and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart. The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.

Primary Outcome

Change from baseline in HbA1c after 26 weeks of treatment

Conditions Studied

Diabetes Diabetes Mellitus, Type 1

Interventions

  • DRUG insulin aspart
  • DRUG insulin degludec/insulin aspart
  • DRUG insulin detemir

Study Locations (20)

California

  • Novo Nordisk Investigational Site - La Mesa
  • Novo Nordisk Investigational Site - Lancaster
  • Novo Nordisk Investigational Site - Mission Hills
  • Novo Nordisk Investigational Site - North Hollywood
  • Novo Nordisk Investigational Site - Salinas
  • Novo Nordisk Investigational Site - Valencia

Georgia

  • Novo Nordisk Investigational Site - Atlanta
  • Novo Nordisk Investigational Site - Lawrenceville
  • Novo Nordisk Investigational Site - Roswell

Florida

  • Novo Nordisk Investigational Site - Miami
  • Novo Nordisk Investigational Site - Miami

Minnesota

  • Novo Nordisk Investigational Site - Eagan
  • Novo Nordisk Investigational Site - Minneapolis

Colorado

  • Novo Nordisk Investigational Site - Aurora

Hawaii

  • Novo Nordisk Investigational Site - Honolulu

Illinois

  • Novo Nordisk Investigational Site - Chicago

Kansas

  • Novo Nordisk Investigational Site - Shawnee Mission

Trial Details

FieldValue
Enrollment Target 548 participants
Start Date 2009-08
Est. Completion 2010-05
Phase Phase 3
Novo Nordisk A/S

431 total trials

What the finished NCT00978627 record still lists

NCT00978627 is an interventional study that assigns participants to a tested intervention. The registered 548 participants enrollment target is mid-sized for trials with a published cap, below the 3,027-participant average among 338 other Diabetes trials with a reported enrollment target (82% lower).

The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 3 interventions - of which insulin aspart is the first listed.

NCT00978627 names 20 study sites across 11 states, led by California, Georgia, Florida.

Frequently Asked Questions

What is clinical trial NCT00978627 about?

NCT00978627 is a clinical study titled "Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes". This trial is conducted in Europe, Oceania, and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extensio...

What is the current status of trial NCT00978627?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 548 participants. The study started on 2009-08. Estimated completion is 2010-05.

What conditions does trial NCT00978627 study?

This clinical trial studies the following conditions: Diabetes, Diabetes Mellitus, Type 1.

What interventions are being tested in trial NCT00978627?

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

Who is sponsoring clinical trial NCT00978627?

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

Where is trial NCT00978627 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Diabetes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00978627's enrollment target sits among peer trials

548 69th of 338 higher than 270 of 338 other Diabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes 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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Related registry views

Source: ClinicalTrials.gov NCT00978627, the US trial registry maintained by the National Library of Medicine. NCT00978627 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.