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NCT03078478 · ClinicalTrials.gov registry record · Phase 3
A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs
A Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,609
- Enrollment target
- 20
- Study locations
NCT03078478 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 1,609 participants, below the 4,481-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 3 states.
The verdict
NCT03078478, 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
- 1,609 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs. Due to change in glycaemic data collection process, this trial is amended to allow for a full 36 weeks (maintenance 2 period) of the use of the new process.
Conditions Studied
Interventions
- DRUG Insulin glargine
- DRUG Insulin degludec
Study Locations (20)
California
- Novo Nordisk Investigational Site - Buena Park
- Novo Nordisk Investigational Site - Concord
- Novo Nordisk Investigational Site - Downey
- Novo Nordisk Investigational Site - Duarte
- Novo Nordisk Investigational Site - Fresno
- Novo Nordisk Investigational Site - La Jolla
- Novo Nordisk Investigational Site - Lancaster
- Novo Nordisk Investigational Site - Lomita
- Novo Nordisk Investigational Site - Los Alamitos
- Novo Nordisk Investigational Site - Los Angeles
- Novo Nordisk Investigational Site - Moreno Valley
Arizona
- Novo Nordisk Investigational Site - Chandler
- Novo Nordisk Investigational Site - Fountain Hills
- Novo Nordisk Investigational Site - Glendale
- Novo Nordisk Investigational Site - Glendale
- Novo Nordisk Investigational Site - Glendale
- Novo Nordisk Investigational Site - Phoenix
- Novo Nordisk Investigational Site - Tucson
Alabama
- Novo Nordisk Investigational Site - Anniston
- Novo Nordisk Investigational Site - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,609 participants |
| Start Date | 2017-03-13 |
| Est. Completion | 2019-03-04 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03078478
The ClinicalTrials.gov registry entry for NCT03078478 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,609 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,481-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (64% 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.
NCT03078478 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT03078478 about?
NCT03078478 is a clinical study titled "A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs". This trial is conducted in Europe and North America. The aim of the trial is to compare the efficacy and safety of insulin degludec and insulin glargine 300 units/mL in subjects with type 2 diabetes mellitus inadequately treated with basal insulin with or without oral antidiabetic drugs. Due to chan...
What is the current status of trial NCT03078478?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,609 participants. The study started on 2017-03-13. Estimated completion is 2019-03-04.
What conditions does trial NCT03078478 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes.
What interventions are being tested in trial NCT03078478?
The interventions under investigation include: Insulin glargine (DRUG), Insulin degludec (DRUG).
Who is sponsoring clinical trial NCT03078478?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03078478 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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