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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 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.

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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.

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

FieldValue
Enrollment Target 302 participants
Start Date 2017-03-15
Est. Completion 2018-08-06
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT03086330

The ClinicalTrials.gov registry entry for NCT03086330 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 302 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 (93% 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 Placebo is the first listed.

NCT03086330 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.