A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin

Part of paid clinical trials in Anaheim, California.

Sponsor
AstraZeneca
Study ID
NCT02551874
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Saxagliptin, Onglyza — DRUG
    Tablets, Oral, 5mg , Once daily, 24 weeks
  • Dapagliflozin, Farxiga — DRUG
    Tablets, Oral, 10mg , Once daily, 24 weeks
  • Glargine insulin — DRUG
    100 Units/ml solution for injection in a prefilled SoloStar pen
  • Metformin — DRUG
    Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks

Study Details

This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM) will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

Key Dates

Start date
Oct 20, 2015
Status verified
Nov 2018
Primary completion
May 8, 2017
Completion
Nov 10, 2017

Study Design

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

Arms

  • Experimental: Saxagliptin/Dapagliflozin/Metformin
    Oral route. Saxagliptin/Dapa adminsitered once daily for 24 weeks at a dose of 5 mg Saxagliptin and 10 mg Dapagliflozin
  • Active Comparator: Insulin Glargine, Lantos/Metformin
    Insulin glargine administered once a day with starting dose of 0.2 Unit per kg or 10 units.

Primary Outcome Measure

Mean Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline and Week 24 ]

Locations (20)

FacilityCityStateZIPSite coordinators
Research SiteAnaheimCalifornia92801-
Research SiteLos AngelesCalifornia90057-
Research SiteMiamiFlorida33144-
Research SiteMiamiFlorida33155-
Research SiteSt. PetersburgFlorida33709-
Research SiteNorcrossGeorgia30071-
Research SiteChicagoIllinois60612-
Research SiteLexingtonKentucky40502-
Research SiteQuincyMassachusetts02169-
Research SiteBeavercreekOhio45432-
Research SiteNormanOklahoma73069-
Research SiteBartoPennsylvania19504-
Research SiteColumbiaSouth Carolina29204-
Research SiteBristolTennessee37620-
Research SiteKingsportTennessee37660-
Research SiteHoustonTexas77004-
Research SiteMesquiteTexas74194-
Research SiteSan AntonioTexas78230-
Research SiteSan AntonioTexas78258-
Research SiteBountifulUtah84010-

Find similar trials in Anaheim, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Research Site· Anaheim, CAResearch Site· Los Angeles, CAResearch Site· Miami, FLResearch Site· St. Petersburg, FLResearch Site· Norcross, GAResearch Site· Chicago, IL

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