Dapagliflozin, Cardio-Metabolic Risk Factors and Type-2 Diabetes

Sponsor
University of Palermo
Study ID
NCT03377335
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg — DRUG
    The subjects in this arm will receive dapagliflozin (10mg daily) as add-on to metformin therapy (doses ranging from 1500 to 3000 mg daily). Number of patients to be randomized: 93 Number of patients expected to complete the study: \>87 All the other medications (including lipid-lowering, anti-hypertensive and anti-platelet agents) will be maintained at fixed doses during the treatment.
  • Metformin — DRUG
    All the subjects in this arm will be on metformin therapy only (doses ranging from 1500 to 3000 mg daily). Number of patients to be randomized: 93 Number of patients expected to complete the study: \>87 All the other medications (including lipid-lowering, anti-hypertensive and anti-platelet agents) will be maintained at fixed doses during the treatment.

Study Details

Dapagliflozin is a member of the sodium-glucose cotransporter-2 (SGLT2) inhibitor class antidiabetes agents which produces significant and sustained reductions in glycemic parameters in patients with type 2 diabetes (T2DM). However, its non-glycemic effects are still largely unknown. The investigators will evaluate for the first time the effect of dapagliflozin on multiple cardio-metabolic risk markers in one study. So far, no data on the effects of dapagliflozin as well as other SGLT-2 inhibitors on subclinical atherosclerosis, endothelial function, inflammatory markers, cytokines and atherogenic lipoproteins is available. In addition, the investigators will examine microRNAs (miRNAs) implicated in the development and progression of atherosclerotic disease. Again, no data is currently available on dapaglifozin's as well as other SGLT-2 inhibitors' effects on miRNAs. The results of this study will show for the first time the potential multiple, non-glycemic effects of dapagliflozin, reducing multiple cardio-metabolic risk markers, which will ultimately lead to decreased CV risk. In addition, specific mechanisms of the dapagliflozin cardiovascular action will be investigated. Finally, the results of this study may pave the way for personalized therapy (using the results on miRNAs).

Key Dates

Start date
Dec 22, 2017
Status verified
Dec 2017
Primary completion
Dec 31, 2018
Completion
Jan 31, 2019

Study Design

Enrollment
186 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin (10mg daily) as add-on to metformin (stable doses ranging from 1500 to 3000 mg daily). The total duration of treatment is 6 months.
  • Placebo Comparator: Metformin alone
    Metformin alone (stable doses ranging from 1500 to 3000 mg daily). The total duration of treatment is 6 months.

Primary Outcome Measure

Subclinical atherosclerosis [ Time Frame: Change from baseline to 6 months of the treatment ]

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