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NCT01045447 · ClinicalTrials.gov registry record · Phase 3

Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes

A Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.

Completed
Registry status
Phase 3
Development phase
465
Enrollment target
20
Study locations

NCT01045447 is a Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes that has completed, run by Novo Nordisk A/S. The registered enrollment target is 465 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT01045447, a Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, has completed, sponsored by Novo Nordisk A/S.

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

Study Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.

Interventions

  • DRUG insulin glargine
  • DRUG insulin degludec/insulin aspart

Study Locations (20)

Florida

  • Novo Nordisk Investigational Site - Boynton Beach
  • Novo Nordisk Investigational Site - Clearwater
  • Novo Nordisk Investigational Site - Jacksonville
  • Novo Nordisk Investigational Site - Kissimmee
  • Novo Nordisk Investigational Site - New Port Richey
  • Novo Nordisk Investigational Site - Orlando
  • Novo Nordisk Investigational Site - Pembroke Pines
  • Novo Nordisk Investigational Site - Tampa

Maryland

  • Novo Nordisk Investigational Site - Baltimore
  • Novo Nordisk Investigational Site - Hyattsville

Michigan

  • Novo Nordisk Investigational Site - Southfield
  • Novo Nordisk Investigational Site - Southfield

California

  • Novo Nordisk Investigational Site - Fresno

Connecticut

  • Novo Nordisk Investigational Site - Waterbury

Georgia

  • Novo Nordisk Investigational Site - Atlanta

Iowa

  • Novo Nordisk Investigational Site - Des Moines

Massachusetts

  • Novo Nordisk Investigational Site - Waltham

Trial Details

FieldValue
Enrollment Target 465 participants
Start Date 2010-01
Est. Completion 2010-10
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT01045447

The ClinicalTrials.gov registry entry for NCT01045447 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 465 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (90% lower). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.

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

NCT01045447 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Maryland, Michigan.

Frequently Asked Questions

What is clinical trial NCT01045447 about?

NCT01045447 is a clinical study titled "Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes". This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OAD...

What is the current status of trial NCT01045447?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 465 participants. The study started on 2010-01. Estimated completion is 2010-10.

What conditions does trial NCT01045447 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes.

What interventions are being tested in trial NCT01045447?

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

Who is sponsoring clinical trial NCT01045447?

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

Where is trial NCT01045447 being conducted?

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

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

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