A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

Part of paid clinical trials in Muscle Shoals, Alabama.

Sponsor
Novo Nordisk A/S
Study ID
NCT02501161
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 for 104 weeks. Dose individually adjusted.
  • insulin glargine — DRUG
    Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.

Study Details

This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.

Key Dates

Start date
Jan 31, 2016
Status verified
Nov 2019
Primary completion
Oct 3, 2018
Completion
Oct 3, 2018

Study Design

Enrollment
1,012 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Insulin degludec/liraglutide QD + OAD(s)
  • Active Comparator: insulin glargine QD + OAD(s)

Primary Outcome Measure

Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification [ Time Frame: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2 ]

Locations (44)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteMuscle ShoalsAlabama35662-
Novo Nordisk Investigational SiteTuscumbiaAlabama35674-
Novo Nordisk Investigational SiteGlendaleArizona85306-4652-
Novo Nordisk Investigational SiteGlendaleArizona85308-
Novo Nordisk Investigational SitePhoenixArizona85018-
Novo Nordisk Investigational SitePhoenixArizona85020-
Novo Nordisk Investigational SitePhoenixArizona85050-
Novo Nordisk Investigational SiteBermuda DunesCalifornia92203-
Novo Nordisk Investigational SiteFresnoCalifornia93720-
Novo Nordisk Investigational SiteLancasterCalifornia93534-
Novo Nordisk Investigational SiteMontereyCalifornia93940-
Novo Nordisk Investigational SiteSacramentoCalifornia95821-
Novo Nordisk Investigational SiteSpring ValleyCalifornia91978-
Novo Nordisk Investigational SiteVenturaCalifornia93003-
Novo Nordisk Investigational SiteWalnut CreekCalifornia94598-
Novo Nordisk Investigational SiteColorado SpringsColorado80910-
Novo Nordisk Investigational SiteBoynton BeachFlorida33472-
Novo Nordisk Investigational SiteLake WorthFlorida33461-
Novo Nordisk Investigational SiteMiamiFlorida33135-
Novo Nordisk Investigational SiteBlackfootIdaho83221-
Novo Nordisk Investigational SiteAvonIndiana46123-
Novo Nordisk Investigational SiteIndianapolisIndiana46254-
Novo Nordisk Investigational SiteMetairieLouisiana70002-
Novo Nordisk Investigational SiteHyattsvilleMaryland20782-
Novo Nordisk Investigational SiteRockvilleMaryland20852-
Novo Nordisk Investigational SiteWalthamMassachusetts02453-
Novo Nordisk Investigational SiteBuckleyMichigan49620-
Novo Nordisk Investigational SiteBillingsMontana59101-
Novo Nordisk Investigational SiteNashuaNew Hampshire03063-
Novo Nordisk Investigational SiteAlbuquerqueNew Mexico87102-
Novo Nordisk Investigational SiteNew WindsorNew York12553-
Novo Nordisk Investigational SiteMasonOhio45040-6815-
Novo Nordisk Investigational SiteMaumeeOhio43537-
Novo Nordisk Investigational SiteBeaverPennsylvania15009-
Novo Nordisk Investigational SiteGreerSouth Carolina29651-
Novo Nordisk Investigational SiteHumboldtTennessee38343-
Novo Nordisk Investigational SiteDallasTexas75251-
Novo Nordisk Investigational SiteHoustonTexas77040-
Novo Nordisk Investigational SiteIrvingTexas75061-2210-
Novo Nordisk Investigational SiteKatyTexas77450-
Novo Nordisk Investigational SiteSan AntonioTexas78215-
Novo Nordisk Investigational SiteMidlothianVirginia23114-
Novo Nordisk Investigational SiteKenoshaWisconsin53142-
Novo Nordisk Investigational SiteKenoshaWisconsin53144-

Find similar trials in Muscle Shoals, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Novo Nordisk Investigational Site· Muscle Shoals, ALNovo Nordisk Investigational Site· Tuscumbia, ALNovo Nordisk Investigational Site· Glendale, AZNovo Nordisk Investigational Site· Phoenix, AZNovo Nordisk Investigational Site· Bermuda Dunes, CANovo Nordisk Investigational Site· Fresno, CA

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