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NCT01618162 · ClinicalTrials.gov registry record · Phase 3

The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy

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

Completed
Registry status
Phase 3
Development phase
435
Enrollment target
20
Study locations

NCT01618162 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 435 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT01618162, 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
435 participants
Enrollment target
20
Study locations

Study Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.

Interventions

  • DRUG placebo
  • DRUG insulin degludec/liraglutide

Study Locations (20)

California

  • Novo Nordisk Investigational Site - Anaheim
  • Novo Nordisk Investigational Site - Garden Grove
  • Novo Nordisk Investigational Site - La Jolla
  • Novo Nordisk Investigational Site - Long Beach
  • Novo Nordisk Investigational Site - Los Angeles
  • Novo Nordisk Investigational Site - San Mateo
  • Novo Nordisk Investigational Site - Walnut Creek

Florida

  • Novo Nordisk Investigational Site - Kissimmee
  • Novo Nordisk Investigational Site - Melbourne
  • Novo Nordisk Investigational Site - Miami
  • Novo Nordisk Investigational Site - Miami

Georgia

  • Novo Nordisk Investigational Site - Atlanta
  • Novo Nordisk Investigational Site - Roswell

Missouri

  • Novo Nordisk Investigational Site - Chesterfield
  • Novo Nordisk Investigational Site - Saint Charles

Idaho

  • Novo Nordisk Investigational Site - Meridian

Illinois

  • Novo Nordisk Investigational Site - Gurnee

Kentucky

  • Novo Nordisk Investigational Site - Crestview Hills

Maryland

  • Novo Nordisk Investigational Site - Rockville

Trial Details

FieldValue
Enrollment Target 435 participants
Start Date 2012-08-29
Est. Completion 2013-10-23
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

What the Registry Record Tells You About NCT01618162

The ClinicalTrials.gov registry entry for NCT01618162 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 435 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 (90% 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.

NCT01618162 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT01618162 about?

NCT01618162 is a clinical study titled "The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy". This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjec...

What is the current status of trial NCT01618162?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 435 participants. The study started on 2012-08-29. Estimated completion is 2013-10-23.

What conditions does trial NCT01618162 study?

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

What interventions are being tested in trial NCT01618162?

The interventions under investigation include: placebo (DRUG), insulin degludec/liraglutide (DRUG).

Who is sponsoring clinical trial NCT01618162?

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

Where is trial NCT01618162 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Idaho, Illinois. 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.