Efficacy and Safety of Dapagliflozin for the Hospital Management of Patients With Type 2 Diabetes

Sponsor
Medanta, The Medicity, India
Study ID
NCT05457933
Phase
PHASE4
Status
Completed

Conditions

  • Coronary Artery Disease
  • Type2diabetes

Eligibility Criteria

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

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg, every day before breakfast. Glargine insulin 300 Units/mL, average dose: 10-20 U/day; Insulin lispro 100 Units/mL, average dose: 10-30 U/day
  • Glargine — DRUG
    Glargine insulin; 300 Units/mL, average dose: 10-20 U/day, Insulin lispro 100 Units/mL, average dose: 10-30 U/day

Study Details

The purpose of the trial is to examine whether treatment with dapagliflozin plus insulin as compared with insulin alone (basal-bolus insulin) will result in similar blood glucose control and similar rate of complications in patients with diabetes, who are admitted to a hospital in a noncritical setting

Key Dates

Start date
Jul 29, 2022
Status verified
Oct 2023
Primary completion
Jan 14, 2023
Completion
Jan 14, 2023

Study Design

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

Arms

  • Experimental: Dapagliflozin group
    Dapagliflozin 10 mg, every day before breakfast. Glargine insulin 300 Units/mL, average dose: 10-20 U/day; Insulin lispro 100 Units/mL, average dose: 10-30 U/day
  • Active Comparator: Basal-bolus group
    Glargine insulin; 300 Units/mL, average dose: 10-20 U/day; Insulin lispro 100 Units/mL, average dose: 10-30 U/day

Primary Outcome Measure

Noninferiority in mean differences between groups in their daily blood glucose concentrations [ Time Frame: The first 7 days of therapy in hospital and 5 days post-discharge ]

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