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COMPLETED Phase 3

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

NCT00978627 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Novo Nordisk A/S

189 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00978627

The ClinicalTrials.gov registry entry for NCT00978627 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 548 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00978627 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Georgia, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00978627?

The interventions under investigation include: insulin aspart (DRUG), insulin degludec/insulin aspart (DRUG), insulin detemir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00978627?

This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial