A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AstraZeneca
Study ID
NCT02413398
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 mg — DRUG
    Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy
  • Matching Placebo for Dapagliflozin — DRUG
    Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks

Study Details

The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regions. It is planned to randomize a total of 302 patients.

Key Dates

Start date
Jun 15, 2015
Status verified
Sep 2018
Primary completion
Nov 7, 2017
Completion
Nov 7, 2017

Study Design

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

Arms

  • Experimental: Dapagliflozin
    10 mg Tablets, Oral, Once daily, 24 weeks
  • Placebo Comparator: Placebo
    Matching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks

Primary Outcome Measure

Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 [ Time Frame: Baseline, Week 24 ]

Locations (27)

FacilityCityStateZIPSite coordinators
Research SiteHuntsvilleAlabama35801-
Research SiteBurbankCalifornia91505-
Research SiteChula VistaCalifornia91910-
Research SiteConcordCalifornia94520-
Research SiteFullertonCalifornia92835-3404-
Research SiteHuntington BeachCalifornia92648-
Research SiteLos GatosCalifornia95032-
Research SiteNewport BeachCalifornia92663-
Research SiteSalinasCalifornia93901-4446-
Research SiteMiamiFlorida33015-
Research SiteMiamiFlorida33144-
Research SiteMiami SpringsFlorida33166-
Research SitePembroke PinesFlorida33027-
Research SiteChicagoIllinois60643-
Research SiteBrownsburgIndiana46112-
Research SiteLouisvilleKentucky40213-
Research SiteMonroeLouisiana71203-
Research SiteFlintMichigan48504-
Research SiteJacksonMichigan39209-
Research SiteChesterfieldMissouri63017-
Research SiteKansas CityMissouri64111-
Research SiteChapel HillNorth Carolina27517-
Research SiteChattanoogaTennessee37404-
Research SiteHoustonTexas77004-
Research SiteSan AntonioTexas78215-
Research SiteSan AntonioTexas78224-
Research SiteManassasVirginia20110-

Find similar trials in Huntsville, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Research Site· Huntsville, ALResearch Site· Burbank, CAResearch Site· Chula Vista, CAResearch Site· Concord, CAResearch Site· Fullerton, CAResearch Site· Huntington Beach, CA

Related Studies