Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT03078478 · View on ClinicalTrials.gov ↗
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 |
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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. 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 1,609 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 2 interventions — of which Insulin glargine 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: NCT03078478 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Alabama. 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 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, Diabetes Mellitus, Type 2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03078478?
The interventions under investigation include: Insulin glargine (DRUG), Insulin degludec (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03078478?
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 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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