Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes

Part of paid clinical trials in Gulf Shores, Alabama.

Sponsor
Boehringer Ingelheim
Study ID
NCT01734785
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

Key Dates

Start date
Feb 8, 2013
Status verified
Aug 2024
Primary completion
Mar 23, 2015
Completion
Mar 23, 2015

Study Design

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

Arms

  • Active Comparator: Linagliptin
    5 mg once daily
  • Experimental: Empagliflozin + Linagliptin low dose
    1 tablet once daily
  • Experimental: Empagliflozin + Linagliptin high dose
    1 tablet once daily

Primary Outcome Measure

HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment [ Time Frame: Baseline and 24 weeks ]

Locations (28)

FacilityCityStateZIPSite coordinators
1275.9.01013 Boehringer Ingelheim Investigational SiteGulf ShoresAlabama--
1275.9.01009 Boehringer Ingelheim Investigational SiteNorwalkCalifornia--
1275.9.01015 Boehringer Ingelheim Investigational SiteSan DiegoCalifornia--
1275.9.01017 Boehringer Ingelheim Investigational SiteSan DiegoCalifornia--
1275.9.01011 Boehringer Ingelheim Investigational SiteNorthglennColorado--
1275.9.01010 Boehringer Ingelheim Investigational SiteCoral GablesFlorida--
1275.9.01004 Boehringer Ingelheim Investigational SiteMiamiFlorida--
1275.9.01006 Boehringer Ingelheim Investigational SiteOldsmarFlorida--
1275.9.01001 Boehringer Ingelheim Investigational SitePalm CoastFlorida--
1275.9.01027 Boehringer Ingelheim Investigational SitePort OrangeFlorida--
1275.9.01029 Boehringer Ingelheim Investigational SiteBlue RidgeGeorgia--
1275.9.01003 Boehringer Ingelheim Investigational SiteMariettaGeorgia--
1275.9.01022 Boehringer Ingelheim Investigational SiteSavannahGeorgia--
1275.9.01031 Boehringer Ingelheim Investigational SiteChicagoIllinois--
1275.9.01019 Boehringer Ingelheim Investigational SiteMethuenMassachusetts--
1275.9.01024 Boehringer Ingelheim Investigational SiteTroyMichigan--
1275.9.01023 Boehringer Ingelheim Investigational SiteSt LouisMissouri--
1275.9.01002 Boehringer Ingelheim Investigational SiteOmahaNebraska--
1275.9.01007 Boehringer Ingelheim Investigational SiteNewingtonNew Hampshire--
1275.9.01016 Boehringer Ingelheim Investigational SiteAsheboroNorth Carolina--
1275.9.01025 Boehringer Ingelheim Investigational SiteBurlingtonNorth Carolina--
1275.9.01014 Boehringer Ingelheim Investigational SiteShelbyNorth Carolina--
1275.9.01028 Boehringer Ingelheim Investigational SiteWinston-SalemNorth Carolina--
1275.9.01018 Boehringer Ingelheim Investigational SiteDaytonOhio--
1275.9.01005 Boehringer Ingelheim Investigational SiteCorvallisOregon--
1275.9.01032 Boehringer Ingelheim Investigational SiteCorpus ChristiTexas--
1275.9.01030 Boehringer Ingelheim Investigational SiteHoustonTexas--
1275.9.01021 Boehringer Ingelheim Investigational SiteSan AntonioTexas--

Find similar trials in Gulf Shores, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
1275.9.01013 Boehringer Ingelheim Investigational Site· Gulf Shores, AL1275.9.01009 Boehringer Ingelheim Investigational Site· Norwalk, CA1275.9.01015 Boehringer Ingelheim Investigational Site· San Diego, CA1275.9.01017 Boehringer Ingelheim Investigational Site· San Diego, CA1275.9.01011 Boehringer Ingelheim Investigational Site· Northglenn, CO1275.9.01010 Boehringer Ingelheim Investigational Site· Coral Gables, FL

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