Efficay and Safety of Empagliflozin Versus Sitagliptin for the In-patient Management of Hyperglycemia

Sponsor
Medanta, The Medicity, India
Study ID
NCT06187285
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Empagliflozin 25 MG — DRUG
    Patient will get Empagliflozin 25
  • Sitagliptin 100mg — DRUG
    Patient will get Sitagliptin 100 mg

Study Details

Clinical guidelines from professional organizations have recommended the use of multidose insulin regimens as the preferred therapy for glycaemic control in patients admitted to hospital in a non-intensive-careunit setting. The use of a basal-bolus regimen with a once daily basal insulin and rapid-acting insulin analogs before meals has been shown to improve glycaemic control and to reduce the rate of hospital complications in general medical and surgical patients with type 2 diabetes.The basal-bolus regimen however is labour intensive, requiring several insulin injections, and is associated with a high risk of hypoglycaemia. Hypoglycaemia has been reported in 12% to 32% of patients in general medicine and surgery with type 2 diabetes treated with basal-bolus insulin regimens.Because of these limitations, alternative treatment regimens are needed that could improve glycaemic control and clinical outcomes, while facilitating care and minimising the risk of hypoglycaemia in patients with diabetes.

Key Dates

Start date
Jan 1, 2024
Status verified
Jun 2025
Primary completion
May 1, 2025
Completion
Jun 1, 2025

Study Design

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

Arms

  • Experimental: Empagliflozin 25 mg
  • Active Comparator: Sitagliptin 100 mg

Primary Outcome Measure

Mean blood glucose concentration [ Time Frame: The first 7 days of therapy in hospital ]

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