Phase 2 Completed N=62 Randomized Triple-blind Basic Science

Does Dapagliflozin Provide Additional Health Benefits To Dietary Counseling For Weight Loss?

Source: ClinicalTrials.gov NCT03180489 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcomePrimary: Change From Baseline in Insulin Sensitivity at Week 12 Via Oral Glucose Tolerance Test — 6.9; 11.1; 5.5; 6.5 mU/L

Summary

Dapagliflozin is a medicine to treat diabetes. Its mechanism of action is via sodium-glucose co-transporter 2 (SGLT2) inhibition. In adults with diabetes, use of sodium-glucose co-transporter 2 inhibitors 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. We wish to compare the health benefits of dietary counseling for weight loss with and without concomitant use of an SGLT2 inhibitor.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Insulin Sensitivity at Week 12 Via Oral Glucose Tolerance Test	6.9; 11.1; 5.5; 6.5	—
PRIMARY Change From Baseline in Blood Pressure at Week 12	116; 112; 69; 69	—
PRIMARY Change From Baseline in Perception of Satiety at Week 12	27; 21; 31; 28	—
PRIMARY Change From Baseline in Perception of Hunger at Week 12	42; 53; 39; 53	—
PRIMARY Change From Baseline in Marker of Inflammation (High Sensitive C-reactive Protein) at Week 12	—	—
PRIMARY Change From Baseline in Marker of Inflammation (Tumor Necrosis Factor Alpha) at Week 12	—	—
PRIMARY Change From Baseline in Marker of Inflammation (Interleukin 6) at Week 12	—	—
PRIMARY Change From Baseline in Hunger Hormone Ghrelin at Week 12	—	—
PRIMARY Change From Baseline in Hunger Hormone Peptide Tyrosine Tyrosine at Week 12	—	—
PRIMARY Change From Baseline in Maker of Oxidative Stress (Oxidized Low Density Lipoprotein) at Week 12	—	—
PRIMARY Change From Baseline in Maker of Oxidative Stress (Low Density Thiobarbituric Acid Reactive Substances) at Week 12	—	—
PRIMARY Change From Baseline in Satiety Hormone Leptin at Week 12	—	—
PRIMARY Change From Baseline in Satiety Hormone Insulin at Week 12	—	—

Eligibility Criteria

Inclusion Criteria

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
Limited exercise participation (maximum of 3/week regularly scheduled activity sessions of 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 enrolment; hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment; acute stroke or trans-ischemic attack within two months prior to enrolment; 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 ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
Blood pressure at randomization: Systolic blood pressure ≥165 mmHg and/or diastolic blood pressure ≥100 mmHg
Individuals who, in the judgment of the medical monitor, may be at risk for dehydration.
Individuals with a history of fragility fracture, or bone mineral density values reflective of risk for fracture (DEXA Z-score <or= to -2 in pre-menopausal women, and men <50, and T-score <or= to -1) will not be permitted to participate.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03180489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.