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NCT01364428 · ClinicalTrials.gov registry record · Phase 3

Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus

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

Completed
Registry status
Phase 3
Development phase
373
Enrollment target
20
Study locations

NCT01364428: Completed Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.

NCT01364428 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 373 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01364428, 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
373 participants
Enrollment target
20
Study locations

Study Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.

Primary Outcome

Change from baseline in HbA1c after 22 weeks of treatment

Interventions

  • DRUG insulin degludec

Study Locations (20)

Florida

  • Novo Nordisk Investigational Site - Bradenton
  • Novo Nordisk Investigational Site - Clearwater
  • Novo Nordisk Investigational Site - Kissimmee
  • Novo Nordisk Investigational Site - Miami
  • Novo Nordisk Investigational Site - Tampa
  • Novo Nordisk Investigational Site - West Palm Beach

California

  • Novo Nordisk Investigational Site - Concord
  • Novo Nordisk Investigational Site - Greenbrae
  • Novo Nordisk Investigational Site - Montclair
  • Novo Nordisk Investigational Site - National City
  • Novo Nordisk Investigational Site - Palm Springs

Arizona

  • Novo Nordisk Investigational Site - Goodyear
  • Novo Nordisk Investigational Site - Mesa
  • Novo Nordisk Investigational Site - Phoenix

Louisiana

  • Novo Nordisk Investigational Site - Metairie
  • Novo Nordisk Investigational Site - Slidell

Alabama

  • Novo Nordisk Investigational Site - Huntsville

Georgia

  • Novo Nordisk Investigational Site - Atlanta

Illinois

  • Novo Nordisk Investigational Site - Springfield

Indiana

  • Novo Nordisk Investigational Site - Evansville

Trial Details

FieldValue
Enrollment Target 373 participants
Start Date 2011-06
Est. Completion 2012-01
Phase Phase 3
Novo Nordisk A/S

431 total trials

What the finished NCT01364428 record still lists

NCT01364428 is an interventional study that assigns participants to a tested intervention. The registered 373 participants enrollment target is mid-sized for trials with a published cap, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (92% lower).

The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention - of which insulin degludec is the first listed.

NCT01364428 names 20 study sites across 8 states, led by Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT01364428 about?

NCT01364428 is a clinical study titled "Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus". This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.

What is the current status of trial NCT01364428?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 373 participants. The study started on 2011-06. Estimated completion is 2012-01.

What conditions does trial NCT01364428 study?

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

What interventions are being tested in trial NCT01364428?

The interventions under investigation include: insulin degludec (DRUG).

Who is sponsoring clinical trial NCT01364428?

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

Where is trial NCT01364428 being conducted?

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

Similar trials for Diabetes Mellitus, Type 2

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 NCT01364428's enrollment target sits among peer trials

373 97th of 348 higher than 251 of 348 other Diabetes Mellitus, Type 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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 NCT01364428, the US trial registry maintained by the National Library of Medicine. NCT01364428 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.