A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT03235050
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI0382 low dose — DRUG
    Pharmaceutical form: solution Route of administration: subcutaneous
  • MEDI0382 mid dose — DRUG
    Pharmaceutical form: solution Route of administration: subcutaneous
  • MEDI0382 high dose — DRUG
    Pharmaceutical form: solution Route of administration: subcutaneous
  • Placebo — DRUG
    Pharmaceutical form: solution Route of administration: subcutaneous
  • Liraglutide — DRUG
    Pharmaceutical form: solution Route of administration: subcutaneous

Study Details

This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382

Key Dates

Start date
Aug 2, 2017
Status verified
Jul 2020
Primary completion
May 3, 2018
Completion
Jun 14, 2019

Study Design

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

Arms

  • Experimental: MEDI0382 low dose + Metformin
    Drug: MEDI0382 low dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
  • Experimental: MEDI0382 mid dose + Metformin
    Drug: MEDI0382 mid dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
  • Experimental: MEDI0382 high dose + Metformin
    Drug: MEDI0382 high dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
  • Placebo Comparator: Placebo + Metformin
    Drug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)
  • Active Comparator: Liraglutide + Metformin
    Drug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Primary Outcome Measure

Change in HbA1c [ Time Frame: From baseline to 14 weeks ]

Locations (22)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35205-
Research SiteChandlerArizona85224-
Research SiteGlendaleArizona85306-
Research SiteGlendaleArizona85308-
Research SiteMesaArizona85213-
Research SiteMariettaGeorgia30067-
Research SiteEvansvilleIndiana47715-
Research SiteBaton RougeLouisiana70808-
Research SiteMetairieLouisiana70006-
Research SiteElkridgeMaryland21075-
Research SiteBridgetonMissouri63044-
Research SiteLas VegasNevada89117-
Research SiteBrooklynNew York11229-
Research SiteMorehead CityNorth Carolina28557-
Research SitePhiladelphiaPennsylvania19104-
Research SiteGreerSouth Carolina29651-
Research SiteHoustonTexas77040-
Research SiteHoustonTexas77074-
Research SitePlanoTexas75093-
Research SiteLaytonUtah84014-
Research SiteArlingtonVirginia22206-
Research SiteManassasVirginia20110-

Find similar trials in Birmingham, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Research Site· Birmingham, ALResearch Site· Chandler, AZResearch Site· Glendale, AZResearch Site· Mesa, AZResearch Site· Marietta, GAResearch Site· Evansville, IN

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