Effect of SGLT-2 Inhibitor Dapagliflozin on Glycemic Variability in Patients With Diabetes Mellitus Type 2

Sponsor
Research Clinical Centre of the Russian Railways, JSC
Study ID
NCT02719756
Phase
PHASE4
Status
Unknown

Conditions

  • Diabetes Mellitus
  • Hypoglycemic Episodes

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    Metformin tablets 1000 mg
  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg tablets
  • Metformin up-titration — DRUG

Study Details

This study will test the hypothesis that early use of combination therapy with dapagliflozin and metformin will provide good glycemic control with low glycemic variability and without hypoglycemic episodes, and will be better tolerated than up-titration of metformin monotherapy. The study will also correlate these benefits with glycated hemoglobin.

Key Dates

Start date
Apr 30, 2016
Status verified
Mar 2016
Primary completion
Oct 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL

Arms

  • Experimental: Metformin & Dapagliflozin
    Metformin stable dose tablets and Dapagliflozin 10 mg tablets by mouths, once daily in morning for 3 months
  • Active Comparator: Metformin up-titration
    Metformin tablets up-titration by mouths, for 3 months

Primary Outcome Measure

Dynamics (delta from the baseline) of blood glucose variability - integral index of glycemia (LBGI-HBGI) after 3 months of therapy [ Time Frame: 3 months ]

Central Contacts

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