Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
AstraZeneca
Study ID
NCT02725593
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg tablets administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily, for the 28-week site and subject blinded long term extension.
  • Dapagliflozin placebo — DRUG
    matching placebo tablets, administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily,for the 28-week site and subject blinded long term extension.

Study Details

A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the comparative efficacy and safety between dapagliflozin and Placebo.

Key Dates

Start date
Jun 22, 2016
Status verified
Jan 2022
Primary completion
Apr 6, 2020
Completion
Apr 6, 2020

Study Design

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

Arms

  • Experimental: Dapagliflozin
  • Placebo Comparator: Dapagliflozin placebo

Primary Outcome Measure

Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline to Week 24 ]

Locations (15)

FacilityCityStateZIPSite coordinators
Research SiteNew HavenConnecticut06514-3434-
Research SiteWashington D.C.District of Columbia20010-
Research SiteGainesvilleFlorida32610-
Research SiteHomesteadFlorida33032-
Research SiteMiamiFlorida33015-
Research SiteBostonMassachusetts02215-
Research SiteBuffaloNew York14222-
Research SiteThe BronxNew York10467-
Research SiteColumbusOhio43205-
Research SitePhiladelphiaPennsylvania19104-
Research SiteGreenvilleSouth Carolina29615-
Research SiteMemphisTennessee38116-
Research SiteMemphisTennessee38119-
Research SiteLampasasTexas76550-
Research SiteMcAllenTexas78503-

Find similar trials in New Haven, CT

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Research Site· New Haven, CTResearch Site· Washington D.C., DCResearch Site· Gainesville, FLResearch Site· Homestead, FLResearch Site· Miami, FLResearch Site· Boston, MA

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