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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03919656
Recruitment Status Not yet recruiting
First Posted April 18, 2019
Last update posted April 23, 2019
This study evaluates the metabolomics changes associated with dapagliflozin treatment in patients with type 2 diabetes mellitus (T2DM). The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily for 12 weeks.
In this study, we hypothesize that metabolomics changes that occur in patients with T2DM after initiating SGLT2i (sodium-glucose cotransporter 2 inhibitors) treatment may be responsible for the beneficial cardiovascular and kidney effects observed in clinical trials with SGLT2i. Also, we propose that the study of the specific metabolome associated with the treatment with SGLT2i could help identify the possible metabolites and molecules that reduce CVD (cardiovascular disease) and renal disease in patients with T2DM. The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily of for 12 weeks. Besides, all participants will be advised to engage in 150 min or more of moderate-to vigorous intensity physical activity per week, spread over at least 3 days/week, with no more than 2 consecutive days without activity and to engage in 2-3 sessions/week of resistance exercise on nonconsecutive days. Moreover, these patients will be advised to follow a lifestyle program that achieve a 500-750 kcal/day energy deficit or provide≈1,200-1,500 kcal/day for women and 1,500-1,800 kcal/day for men, adjusted for the individual's baseline body weight.
Dapagliflozin 10 mg daily (orally)
Drug: Dapagliflozin 10 mg
Dapagliflozin 10 mg daily in a green, plain, diamond shaped, film coated tablet (orally)
|Placebo Comparator: Placebo
Matching placebo for dapagliflozin daily (orally). Does not contain active ingredient
Drug: Placebo Oral Tablet
Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Age 18-75.
- BMI 27-39.9 kg/m2.
- T2DM on treatment with metformin and inadequate metabolic control (defined as
- Pregnancy (all women of child-bearing age, unless on treatment with contraceptive
methods, will undergo a pregnancy test)
- Intolerance/allergy to dapagliflozin.
- Treatment with antidiabetic drug other than metformin.
- Impaired kidney function: Estimated glomerular filtration rate (eGFR) 2.0 mg / dl or GOT/GPT levels three times higher
than normal upper limit.
- Known HIV infection or active HBV or HCV infection.
- Other serious underlying diseases, which could affect the patient's ability to
participate in the study.
- Reduced life expectancy (<12 months) due to advanced or terminal concomitant diseases. In addition, female patients of child-bearing age will be advised to use contraceptive methods during the study period, given the contraindication of dapagliflozin and metformin during pregnancy as per normal clinical practice.
Contact: Jose Carlos Fernandez-Garcia, MD, PhD +34951034016 email@example.com
Virgen de la Victoria University Hospital. Endocrinology Department
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Principal Investigator: Jose Carlos Fernandez-Garcia, MD, PhD Virgen de la Victoria Hospital