Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes

Sponsor
University of Guadalajara
Study ID
NCT02700334
Phase
PHASE4
Status
Completed

Conditions

  • Impaired Fasting Glucose
  • Impaired Glucose Tolerance
  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
30 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    10 mg, one per day before breakfast during 12 weeks.
  • Placebo — DRUG
    one per day before breakfast during 12 weeks.

Study Details

Prediabetes is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, involving a higher risk of progression type 2 diabetes mellitus (T2DM). Dapagliflozin is a selective and reversible inhibitor of sodium-glucose type 2 (SGLT-2) co-transporter, which reduces renal glucose reabsorption and promotes the glucose excretion through urine, so that the blood glucose is improved in patients with T2DM. Although this mechanism is independent of insulin, there are evidence of improved secretion and insulin sensitivity, so it is interesting to assess these effects in patients with prediabetes, as potential therapy for treating such disorders and prevent progression to T2DM. The aim of this study is to evaluate the effect of Dapagliflozin on insulin secretion and insulin sensitivity in patients with prediabetes. The investigators hypothesis is that the administration of dapagliflozin improve insulin secretion and insulin sensitivity in patients with prediabetes.

Key Dates

Start date
Oct 31, 2016
Status verified
Oct 2020
Primary completion
Jan 31, 2017
Completion
Feb 28, 2017

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
  • Placebo Comparator: Placebo
    Placebo capsules, one per day before breakfast during 12 weeks.

Primary Outcome Measure

Fasting Glucose [ Time Frame: Fasting Glucose levels at week 12 ]

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