Phase 2
Completed N=37
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Physical Activity
Source: ClinicalTrials.gov NCT02371187 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Change From Baseline of Maximal Oxygen Uptake at Week 12 — 26.9; 30.1; 30.6; 32.4 Milliliters/Kilogram/Minute
Summary
Exercise is frequently prescribed as a favorable lifestyle intervention to prevent/reverse type 2 diabetes. It is also prescribed in addition to concurrent pharmacological treatment, such as metformin. Recent data (animal and human) suggest that metformin may attenuate the favorable benefits of exercise training. In light of the physiological mechanism of Dapagliflozin (sodium-glucose co-transporter 2 (SGLT2) inhibition), one might speculate that rather than inhibit, it will augment the favorable adaptations to exercise training.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of Maximal Oxygen Uptake at Week 12 |
26.9; 30.1; 30.6; 32.4 | — |
| PRIMARY Change From Baseline of Respiratory Exchange Ratio at Week 12 |
1.91; 1.16; 1.19; 1.13 | — |
| PRIMARY Change From Baseline of Maximal Aerobic Enzyme Activities in Skeletal Muscle at Week 12 |
6.3; 5.8; 8.1; 8.0 | — |
| PRIMARY Change From Baseline of Insulin Sensitivity at Week 12 |
8.7; 8.3; 9.5; 12.9 | — |
| PRIMARY Change From Baseline of Fat Free Mass at Week 12 |
52; 57.8; 52.2; 58.3 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures.
- No known Type 2 Diabetes.
- Body mass index 25-45 kg/m^2
- Sedentary (maximum of 2/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 enrollment; 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 enrollment; less than two months post coronary artery re-vascularization; 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 enrollment: 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.
Data sourced from ClinicalTrials.gov (NCT02371187). 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.