A 52-week International, Multicenter Trial With a Long -Term Extension to Evaluate Saxagliptin With Dapagliflozin in Combination With Metformin Compared to Glimepiride in Combination With Metformin in Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT02419612
Phase
PHASE3
Status
Completed

Conditions

  • Diabetes

Eligibility Criteria

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

Interventions

  • Saxagliptin — DRUG
  • Dapagliflozin — DRUG
  • Glimepiride — DRUG
  • Placebo — OTHER

Study Details

This clincial trial is evaluating if the co-administration of saxagliptin and dapagliflozin, in addition to metformin, results in better glycemic control, as measured by HbA1c, over a treatment period of 52 weeks, compared to the addition of glimepiride to metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on Metformin Alone. We will compare the change from baseline in HbA1c achieved with saxagliptin, in co-administration with dapagliflozin, added to current background therapy with metformin compared to glimepiride added to current background therapy with metformin ≥1500 mg at Week 52.

Key Dates

Start date
Aug 14, 2015
Status verified
Jun 2020
Primary completion
Aug 29, 2017
Completion
Sep 18, 2019

Study Design

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

Arms

  • Experimental: Saxagliptin 5 mg/ dapagliflozin 10mg or Placebo
    Saxagliptin 5 mg /dapagliflozin 10 mg Placebo once a day orally
  • Experimental: Glimepiride or Placebo
    Glimepiride or placebo 1mg or 2mg or 3mg or 4mg or 6mg once a day orally

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52 [ Time Frame: Baseline and Week 52 ]

Locations (22)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35211-
Research SiteChandlerArizona85224-
Research SiteTempeArizona85283-
Research SiteHuntington ParkCalifornia90255-
Research SiteLos AngelesCalifornia90057-
Research SiteSacramentoCalifornia95823-
Research SiteTarzanaCalifornia91356-
Research SiteWaterburyConnecticut06708-
Research SiteJacksonvilleFlorida32207-
Research SiteJacksonvilleFlorida32277-
Research SiteKissimmeeFlorida34744-
Research SiteMiamiFlorida33126-
Research SiteMiamiFlorida33174-
Research SiteNew Port RicheyFlorida34652-
Research SitePalm HarborFlorida34684-
Research SiteEdinaMinnesota55435-
Research SiteLas VegasNevada89128-
Research SiteGreerSouth Carolina29651-
Research SiteBristolTennessee37620-
Research SiteKnoxvilleTennessee37912-
Research SiteDallasTexas75230-
Research SiteSan AntonioTexas78229-

Find similar trials in Birmingham, AL

By research site
Research Site· Birmingham, ALResearch Site· Chandler, AZResearch Site· Tempe, AZResearch Site· Huntington Park, CAResearch Site· Los Angeles, CAResearch Site· Sacramento, CA

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