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NCT03086330 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i 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
- 302
- Enrollment target
- 20
- Study locations
NCT03086330: Completed Phase 3 study of Diabetes Mellitus, Type 2 and Diabetes, sponsored by Novo Nordisk A/S.
NCT03086330 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 302 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03086330, 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
- 302 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.
Primary Outcome
Change from baseline (week 0) in HbA1c was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: 1) the last dose of trial product + 7 days or 2) initiation of rescue medication.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Semaglutide
Study Locations (20)
Arizona
- Novo Nordisk Investigational Site - Glendale
- Novo Nordisk Investigational Site - Phoenix
- Novo Nordisk Investigational Site - Tempe
California
- Novo Nordisk Investigational Site - La Jolla
- Novo Nordisk Investigational Site - Lincoln
- Novo Nordisk Investigational Site - Northridge
Alabama
- Novo Nordisk Investigational Site - Andalusia
- Novo Nordisk Investigational Site - Anniston
Florida
- Novo Nordisk Investigational Site - Edgewater
- Novo Nordisk Investigational Site - Maitland
Georgia
- Novo Nordisk Investigational Site - Lawrenceville
- Novo Nordisk Investigational Site - Woodstock
New York
- Novo Nordisk Investigational Site - Albany
- Novo Nordisk Investigational Site - Smithtown
Arkansas
- Novo Nordisk Investigational Site - Little Rock
Kansas
- Novo Nordisk Investigational Site - Hutchinson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 302 participants |
| Start Date | 2017-03-15 |
| Est. Completion | 2018-08-06 |
| Phase | Phase 3 |
What the finished NCT03086330 record still lists
NCT03086330 is an interventional study that assigns participants to a tested intervention. The registered 302 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 (93% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03086330 names 20 study sites across 12 states, led by Arizona, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT03086330 about?
NCT03086330 is a clinical study titled "Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to SGLT-2i in Subjects With Type 2 Diabetes Mellitus". This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glyca...
What is the current status of trial NCT03086330?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 302 participants. The study started on 2017-03-15. Estimated completion is 2018-08-06.
What conditions does trial NCT03086330 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes.
What interventions are being tested in trial NCT03086330?
The interventions under investigation include: Placebo (DRUG), Semaglutide (DRUG).
Who is sponsoring clinical trial NCT03086330?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03086330 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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 NCT03086330's enrollment target sits among peer trials
302 122nd of 348 higher than 227 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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COMPLETED · Phase 3
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