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

Part of paid clinical trials in Anaheim, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT01618162
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • insulin degludec/liraglutide — DRUG
    Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
  • placebo — DRUG
    Injected subcutaneously (under the skin) once daily.

Study Details

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.

Key Dates

Start date
Aug 29, 2012
Status verified
Sep 2017
Primary completion
Oct 23, 2013
Completion
Oct 23, 2013

Study Design

Enrollment
435 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Insulin degludec/liraglutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 26 ]

Locations (44)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteAnaheimCalifornia92801-
Novo Nordisk Investigational SiteGarden GroveCalifornia92844-
Novo Nordisk Investigational SiteLa JollaCalifornia92037-
Novo Nordisk Investigational SiteLong BeachCalifornia90807-
Novo Nordisk Investigational SiteLos AngelesCalifornia90057-
Novo Nordisk Investigational SiteSan MateoCalifornia94401-
Novo Nordisk Investigational SiteWalnut CreekCalifornia94598-
Novo Nordisk Investigational SiteKissimmeeFlorida34741-
Novo Nordisk Investigational SiteMelbourneFlorida32934-
Novo Nordisk Investigational SiteMiamiFlorida33136-
Novo Nordisk Investigational SiteMiamiFlorida33156-
Novo Nordisk Investigational SiteAtlantaGeorgia30318-
Novo Nordisk Investigational SiteRoswellGeorgia30076-
Novo Nordisk Investigational SiteMeridianIdaho83646-
Novo Nordisk Investigational SiteGurneeIllinois60031-
Novo Nordisk Investigational SiteCrestview HillsKentucky41017-3464-
Novo Nordisk Investigational SiteRockvilleMaryland20852-
Novo Nordisk Investigational SiteTroyMichigan48098-
Novo Nordisk Investigational SiteChesterfieldMissouri63017-
Novo Nordisk Investigational SiteSaint CharlesMissouri63303-
Novo Nordisk Investigational SiteNashuaNew Hampshire03063-
Novo Nordisk Investigational SiteLodiNew Jersey076444-
Novo Nordisk Investigational SiteWest SenecaNew York14224-
Novo Nordisk Investigational SiteTabor CityNorth Carolina28463-
Novo Nordisk Investigational SiteCincinnatiOhio45220-2213-
Novo Nordisk Investigational SiteFranklinOhio45005-
Novo Nordisk Investigational SiteMasonOhio45040-6815-
Novo Nordisk Investigational SiteOklahoma CityOklahoma73104-5020-
Novo Nordisk Investigational SiteBeaverPennsylvania15009-
Novo Nordisk Investigational SitePhiladelphiaPennsylvania19152-
Novo Nordisk Investigational SiteGreerSouth Carolina29651-
Novo Nordisk Investigational SitePelzerSouth Carolina29669-
Novo Nordisk Investigational SiteSimpsonvilleSouth Carolina29681-
Novo Nordisk Investigational SiteSpartanburgSouth Carolina29303-
Novo Nordisk Investigational SiteChattanoogaTennessee37404-
Novo Nordisk Investigational SiteKingsportTennessee37660-
Novo Nordisk Investigational SiteNashvilleTennessee37203-
Novo Nordisk Investigational SiteDallasTexas75203-
Novo Nordisk Investigational SiteDallasTexas75251-
Novo Nordisk Investigational SiteHurstTexas76054-
Novo Nordisk Investigational SiteSugar LandTexas77478-
Novo Nordisk Investigational SiteSalt Lake CityUtah84107-
Novo Nordisk Investigational SiteNewport NewsVirginia23606-
Novo Nordisk Investigational SiteRichmondVirginia23219-

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