Metabolic Responses of Dapagliflozin vs Sitagliptin in T2DM Patients Inadequately Controlled With Insulin Therapy

Sponsor
The University of Hong Kong
Study ID
NCT03959501
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 mg — DRUG
    Dapagliflozin 10mg daily for 24 weeks
  • Sitagliptin 100mg — DRUG
    Sitagliptin 100mg daily for 24 weeks

Study Details

The use of sodium glucose co-transporter 2 inhibitors (SGLT2i) has been associated with increased serum ketone levels. However, most previous studies included subjects who were either insulin or even drug naïve with relatively short duration of diabetes. It is well known that insulin deficiency increases the risk of developing ketoacidosis with SGLT2 inhibitors. Moreover, since the glucose-lowering effect of SGLT2 inhibitors is at its maximum at 3 to 6 months after use, the extent of increase in serum ketone levels and its clinical relevance with chronic use of SGLT2 inhibitors, especially among insulin-treated patients that often have longer duration of diabetes and potentially more insulin deficient than those who are insulin naive, have not been clearly defined. Therefore, the investigators perform this randomised study to evaluate the effect of SGLT2 inhibitors on serum ketone levels among Chinese patients with T2DM inadequately controlled with insulin therapy.

Key Dates

Start date
Aug 16, 2017
Status verified
Nov 2020
Primary completion
Oct 16, 2020
Completion
Oct 16, 2020

Study Design

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

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10mg daily PO for 24 weeks
  • Active Comparator: Sitagliptin
    Sitagliptin 100mg daily PO for 24 weeks

Primary Outcome Measure

Change in serum ketone levels after treatment [ Time Frame: 24 weeks ]

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