Does Dapagliflozin Promote Favorable Health Benefits That Are Independent Of Weight Loss?

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Weight Loss

In brief

Th mechanism of action of dapagliflozin is via sodium-glucose co-transporter 2 (SGLT2) inhibition. Sodium-glucose co-transporter 2 inhibition is associated with moderate weight (fat) loss, in addition to other health benefits, including decreased blood pressure, decreased inflammation, and decreased oxidative stress. It is unclear as to whether these health benefits are due to SGLT2 inhibition per se, or as a secondary effect of weight loss.

Key facts

Study ID

NCT02520518

Run by

Christopher Bell

People needed

9

Starts

2015-08-01

Expected to finish

2017-05-01

Last updated by the study team

2019-01-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provision of informed consent prior to any study specific procedures.
• Aged 18-65 years.
• No known Type 2 Diabetes
• Body mass index greater than or equal to 27.5 kg/m\^2
• Sedentary (maximum of 2/week regularly scheduled activity sessions of < 20 minutes during the previous 2 years)
• Completion of a screening visit consisting of medical history, physical examination, and 12-lead electrocardiogram and blood pressure assessment at rest and during incremental exercise to volitional exhaustion (Note: Subjects with abnormal screening values may be eligible if the results are not clinically significant, as judged by the investigator or medical monitor)
• Agree to abide by the study schedule and dietary restrictions and to return for the required assessments
• Women of childbearing potential must have negative pregnancy test and be using acceptable contraception

You may not qualify if…

• Evidence of clinically significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, haematological, neurological, psychiatric, or other disease that may interfere with the objectives of the study or the safety of the subject, as judged by the investigator in agreement with the sponsor or medical monitor, have been hospitalized in the past 2 years as a result of these conditions, or are receiving pharmacological treatment for these conditions
• Use of prescription drugs (see exceptions listed below) or herbal preparations in the 4 weeks before study commencement.
• Permitted Prescription Drugs
• Birth Control
• Less than 7 days, short course antibiotics. Note: Rifampin is not permitted.
• Other medicines, for Gastroesophageal Reflux Disease (GERD), depression, seasonal allergies and over-the-counter analgesics, maybe allowed, but will be approved on a case-by-case basis.
• Is currently enrolled in another clinical study for another investigational drug or has taken any other investigational drug within 30 days before the screening visit.
• Habitual and/or recent use (within 2 years) of tobacco
• Being considered unsuitable for participation in this trial for any reason, as judged by the investigator or medical monitor.
• History of serious hypersensitivity reaction to dapagliflozin
• Severe renal impairment, end-stage renal disease, or dialysis
• Pregnant or breastfeeding patients
• Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal and/or alanine aminotransferase (ALT) >3x upper limit of normal
• Total bilirubin >2.0 mg/dL (34.2 umol/L)
• Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody Immunoglobulin M, Hepatitis B surface antigen and Hepatitis C virus antibody
• Estimated Glomerular Filtration Rate <60 mL/min/1.73 m\^2 (calculated by Cockcroft-Gault formula).
• History of bladder cancer
• Recent cardiovascular events in a patient, including any of the following: acute coronary syndrome within 2 months prior to enrollment; hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrollment; acute stroke or trans-ischemic attack within two months prior to enrollment; less than two months post coronary artery revascularization; congestive heart failure defined as New York Heart Association class IV,unstable or acute congestive heart failure. Note: eligible patients with congestive heart failure, especially those who are on diuretic therapy, should have careful monitoring of their volume status throughout the study
• Blood pressure at enrolment: Systolic blood pressure ≥165 mmHg and/or diastolic blood pressure ≥100 mmHg
• Blood pressure at randomization: Systolic blood pressure ≥165 mmHg and/or diastolic blood pressure ≥100 mmHg
• Patients who, in the judgment of the medical monitor, may be at risk for dehydration

Where it is running

• Colorado State University, Dept. of Health and Exercise Science — Fort Collins, Colorado, United States

Full record on ClinicalTrials.gov

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