The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

Part of paid clinical trials in Anaheim, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT01664247
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • insulin degludec — DRUG
    Administered s.c. (under the skin) once daily. Dose individually adjusted.
  • placebo — DRUG
    Administered s.c. (under the skin) once daily. Dose individually adjusted.
  • liraglutide — DRUG
    Administered s.c. (under the skin) once daily. Dose: 1.8 mg.

Study Details

This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.

Key Dates

Start date
Oct 1, 2012
Status verified
Aug 2017
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

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

Arms

  • Experimental: IDeg + Lira
  • Experimental: Placebo + Lira

Primary Outcome Measure

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

Locations (67)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteAnaheimCalifornia92801-
Novo Nordisk Investigational SiteConcordCalifornia94520-
Novo Nordisk Investigational SiteEscondidoCalifornia92025-
Novo Nordisk Investigational SiteFresnoCalifornia93720-
Novo Nordisk Investigational SiteHuntington BeachCalifornia92648-
Novo Nordisk Investigational SiteLa JollaCalifornia92037-
Novo Nordisk Investigational SiteLos AngelesCalifornia90057-
Novo Nordisk Investigational SiteMontereyCalifornia93940-
Novo Nordisk Investigational SiteSpring ValleyCalifornia91978-
Novo Nordisk Investigational SiteWalnut CreekCalifornia94598-
Novo Nordisk Investigational SiteBoynton BeachFlorida33472-
Novo Nordisk Investigational SiteClearwaterFlorida33765-
Novo Nordisk Investigational SiteHollywoodFlorida33021-
Novo Nordisk Investigational SiteJacksonvilleFlorida32207-
Novo Nordisk Investigational SiteMiamiFlorida33135-
Novo Nordisk Investigational SiteMiamiFlorida33156-
Novo Nordisk Investigational SiteNew Port RicheyFlorida34652-
Novo Nordisk Investigational SitePalm HarborFlorida34684-
Novo Nordisk Investigational SiteTampaFlorida33603-
Novo Nordisk Investigational SiteDecaturGeorgia30033-
Novo Nordisk Investigational SitePerryGeorgia31069-
Novo Nordisk Investigational SiteRoswellGeorgia30076-
Novo Nordisk Investigational SiteChicagoIllinois60607-
Novo Nordisk Investigational SiteSpringfieldIllinois62711-
Novo Nordisk Investigational SiteTopekaKansas66606-
Novo Nordisk Investigational SitePaducahKentucky42003-
Novo Nordisk Investigational SiteMetairieLouisiana70002-
Novo Nordisk Investigational SiteHyattsvilleMaryland20782-
Novo Nordisk Investigational SiteBuckleyMichigan49620-
Novo Nordisk Investigational SiteChesterfieldMissouri63017-3632-
Novo Nordisk Investigational SiteHendersonNevada89052-2649-
Novo Nordisk Investigational SiteNashuaNew Hampshire03063-
Novo Nordisk Investigational SiteLawrencevilleNew Jersey08648-
Novo Nordisk Investigational SiteToms RiverNew Jersey08755-8050-
Novo Nordisk Investigational SiteNorthportNew York11768-
Novo Nordisk Investigational SiteSmithtownNew York11787-
Novo Nordisk Investigational SiteWest SenecaNew York14224-
Novo Nordisk Investigational SiteChapel HillNorth Carolina27517-
Novo Nordisk Investigational SiteGreensboroNorth Carolina27408-
Novo Nordisk Investigational SiteMorehead CityNorth Carolina28557-
Novo Nordisk Investigational SiteCincinnatiOhio45255-
Novo Nordisk Investigational SiteDaytonOhio45439-
Novo Nordisk Investigational SiteFranklinOhio45005-
Novo Nordisk Investigational SitePhiladelphiaPennsylvania19152-
Novo Nordisk Investigational SiteGreerSouth Carolina29651-
Novo Nordisk Investigational SiteSimpsonvilleSouth Carolina29681-
Novo Nordisk Investigational SiteChattanoogaTennessee37404-1192-
Novo Nordisk Investigational SiteChattanoogaTennessee37411-
Novo Nordisk Investigational SiteHumboldtTennessee38343-
Novo Nordisk Investigational SiteKingsportTennessee37660-
Novo Nordisk Investigational SiteNashvilleTennessee37212-
Novo Nordisk Investigational SiteAustinTexas78731-
Novo Nordisk Investigational SiteDallasTexas75230-
Novo Nordisk Investigational SiteDallasTexas75231-
Novo Nordisk Investigational SiteDallasTexas75246-
Novo Nordisk Investigational SiteDallasTexas75390-
Novo Nordisk Investigational SiteHoustonTexas77030-2703-
Novo Nordisk Investigational SiteIrvingTexas75061-2210-
Novo Nordisk Investigational SiteLubbockTexas79423-
Novo Nordisk Investigational SiteRound RockTexas78681-
Novo Nordisk Investigational SiteSan AntonioTexas78224-
Novo Nordisk Investigational SiteSugar LandTexas77478-
Novo Nordisk Investigational SiteSalt Lake CityUtah84107-
Novo Nordisk Investigational SiteSt. GeorgeUtah84790-
Novo Nordisk Investigational SiteNewport NewsVirginia23606-
Novo Nordisk Investigational SiteSpokaneWashington99218-
Novo Nordisk Investigational SiteMilwaukeeWisconsin53209-

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