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

NCT06187285 | Completed DMC

• 1 other identifier: MMDNB01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Mean blood glucose concentration

  Blood glucose will be measured pre-breakfast, pre-lunch, pre-dinner and bed time. Mean daily blood glucose concentration will be calculated to determine differences in inpatient glycemic control in patients with type 2 diabetes treated with empagliflozin 25 mg (Empa Group) or sitagliptin 100 mg (Sita Group). Both groups will receive basal insulin and/or supplemental bolus insulin

  The first 7 days of therapy in hospital

Secondary Outcomes (9)

• Number of basic glucose readings between 70 mg/dl and 180 mg/dl before meals and bed time in hospitalized patients

  The first 7 days of therapy in hospital

• Number of hypoglycemic episodes (BG < 70 mg/dl and 54 mg/dl) in hospitalized patients.

  The first 7 days of therapy in hospital

• Number of severe hypoglycemia (< 54 mg/dl) episodes in hospitalized patients

  The first 7 days of therapy in hospital

• Number of episodes of severe hyperglycemia (BG > 240 mg/dl) in hospitalized patients.

  The first 7 days of therapy in hospital

• Daily dose of basal insulin, daily dose of prandial insulin, and total daily dose in hospitalized patients.

  The first 7 days of therapy in hospital

Study Arms (2)

Empagliflozin 25 mg

EXPERIMENTAL

Drug: Empagliflozin 25 MG

Sitagliptin 100 mg

ACTIVE COMPARATOR

Drug: Sitagliptin 100mg

Interventions

Empagliflozin 25 MG DRUG

Patient will get Empagliflozin 25

Empagliflozin 25 mg

Sitagliptin 100mg DRUG

Patient will get Sitagliptin 100 mg

Sitagliptin 100 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-years and above with type 2 diabetes and a random blood glucose concentration of 140-400 mg/dL who were being treated with diet or oral antidiabetic drugs or had a total daily insulin dose of 0•6 units per kg or less, admitted to general medicine or surgery

You may not qualify if:

• Patients with a blood glucose concentration greater than 400mg/dL or with current or previous history of diabetic ketoacidosis,
• Type 1 diabetes,
• Hyperglycaemia without a known history of diabetes
• Patients expected to be without oral intake for more than 48 h
• Patients admitted to or expected to require admission to an intensive care unit
• Clinically relevant hepatic disease or impaired renal function \[eGFR\] \<30 mL/min per 1•73 m²)
• Pregnancy, and any mental health condition rendering the patient unable to give informed consent
• Current or recurrent uti(more than 2 times in last 6 months)

Sponsors & Collaborators

• Medanta, The Medicity, India: lead
• Diabetes & Endocrinology Foundation: collaborator

Study Sites (1)

Division Of Endocrinology & Diabetes, Medanta The Medicity

Gurgaon, Haryana, 122001, India

Location

Related Publications (10)

• Umpierrez GE, Isaacs SD, Bazargan N, You X, Thaler LM, Kitabchi AE. Hyperglycemia: an independent marker of in-hospital mortality in patients with undiagnosed diabetes. J Clin Endocrinol Metab. 2002 Mar;87(3):978-82. doi: 10.1210/jcem.87.3.8341.

  PMID: 11889147 BACKGROUND

• Moghissi ES, Korytkowski MT, DiNardo M, Einhorn D, Hellman R, Hirsch IB, Inzucchi SE, Ismail-Beigi F, Kirkman MS, Umpierrez GE; American Association of Clinical Endocrinologists; American Diabetes Association. American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. Diabetes Care. 2009 Jun;32(6):1119-31. doi: 10.2337/dc09-9029. Epub 2009 May 8. No abstract available.

  PMID: 19429873 BACKGROUND

• Umpierrez GE, Hellman R, Korytkowski MT, Kosiborod M, Maynard GA, Montori VM, Seley JJ, Van den Berghe G; Endocrine Society. Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2012 Jan;97(1):16-38. doi: 10.1210/jc.2011-2098.

  PMID: 22223765 BACKGROUND

• Pomposelli JJ, Baxter JK 3rd, Babineau TJ, Pomfret EA, Driscoll DF, Forse RA, Bistrian BR. Early postoperative glucose control predicts nosocomial infection rate in diabetic patients. JPEN J Parenter Enteral Nutr. 1998 Mar-Apr;22(2):77-81. doi: 10.1177/014860719802200277.

  PMID: 9527963 BACKGROUND

• Capes SE, Hunt D, Malmberg K, Pathak P, Gerstein HC. Stress hyperglycemia and prognosis of stroke in nondiabetic and diabetic patients: a systematic overview. Stroke. 2001 Oct;32(10):2426-32. doi: 10.1161/hs1001.096194.

  PMID: 11588337 BACKGROUND

• van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.

  PMID: 11794168 BACKGROUND

• Williams LS, Rotich J, Qi R, Fineberg N, Espay A, Bruno A, Fineberg SE, Tierney WR. Effects of admission hyperglycemia on mortality and costs in acute ischemic stroke. Neurology. 2002 Jul 9;59(1):67-71. doi: 10.1212/wnl.59.1.67.

  PMID: 12105309 BACKGROUND

• Kuchay MS, Khatana P, Mishra M, Surendran P, Kaur P, Wasir JS, Gill HK, Singh A, Jain R, Kohli C, Bakshi G, Radhika V, Saheer S, Singh MK, Mishra SK. Dapagliflozin for inpatient hyperglycemia in cardiac surgery patients with type 2 diabetes: randomised controlled trial (Dapa-Hospital trial). Acta Diabetol. 2023 Nov;60(11):1481-1490. doi: 10.1007/s00592-023-02138-4. Epub 2023 Jun 29.

  PMID: 37380728 BACKGROUND

• Kuchay MS, Mishra SK, Mehta Y. Empagliflozin induced euglycemic diabetic ketoacidosis in a patient undergoing coronary artery bypass graft despite discontinuation of the drug 48 hours prior to the surgery. Diabetes Metab Syndr. 2021 May-Jun;15(3):909-911. doi: 10.1016/j.dsx.2021.04.016. Epub 2021 Apr 22. No abstract available.

  PMID: 33915345 BACKGROUND

• Pasquel FJ, Gianchandani R, Rubin DJ, Dungan KM, Anzola I, Gomez PC, Peng L, Hodish I, Bodnar T, Wesorick D, Balakrishnan V, Osei K, Umpierrez GE. Efficacy of sitagliptin for the hospital management of general medicine and surgery patients with type 2 diabetes (Sita-Hospital): a multicentre, prospective, open-label, non-inferiority randomised trial. Lancet Diabetes Endocrinol. 2017 Feb;5(2):125-133. doi: 10.1016/S2213-8587(16)30402-8. Epub 2016 Dec 8.

  PMID: 27964837 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 2, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

IN (1)