Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2015-09-30
2020-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dapagliflozin and Metformin Group
Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months.
Dapagliflozin
5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.
Metformin
500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL
Metformin and Placebo Group
Participants in this group will receive Metformin and Placebo for 6 months.
Metformin
500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL
Placebo
Placebo pill taken once daily to mimic Dapagliflozin
Interventions
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Dapagliflozin
5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.
Metformin
500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL
Placebo
Placebo pill taken once daily to mimic Dapagliflozin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c \< 8% measured at least 1 week prior to the study
* BMI ≥27 kg/m2
* Pre-treatment with Metformin as monotherapy
* Age \> 18 and \< 65 years old
* Normal and stable hemodynamic status
Exclusion Criteria
* Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
* Insulin dependent or treated type 2 diabetes
* Current use of other SGLT2 inhibitors, Glucagon Like Peptide -1 (GLP- 1) analogs or Dipeptidyl Peptidase 4 (DPP4) inhibitors
* Glomerular Filtration Rate (GFR) \< 60 mL/min/1.73 m2
* Signs or symptoms of hypovolemia
* Patients with poor glycemic control (HbA1c ≥ 8%) will be excluded to maximize long-term patient retention without need
* History of diabetes ketoacidosis
* Patients with active bladder cancer or with a prior history of bladder cancer
* Acute or chronic infective, including genital mycotic infections
* Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
* Clinical or laboratory evidences of chronic active liver diseases
* Acute or chronic infective diseases
* Cancer or chemotherapy
* Current use of systemic corticosteroids or in the 3 months prior this study
* Known or suspected allergy to Dapagliflozin, excipients, or related products
* Pregnant, breast-feeding or the intention of becoming pregnant
* Females of childbearing potential who are not using adequate contraceptive methods
18 Years
64 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
University of Miami
OTHER
Responsible Party
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Gianluca Iacobellis
Professor of Clinical Medicine
Principal Investigators
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Gianluca Iacobellis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20140671
Identifier Type: -
Identifier Source: org_study_id
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