Completed

Dapagliflozin and Insulin for Blood Glucose Control in Hospitalized Type 2 Diabetes Patients

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Study Aim

This study aims to evaluate if the combination of Dapagliflozin and insulin can control blood glucose levels as effectively as a traditional basal-bolus insulin regimen in hospitalized patients with type 2 diabetes.

What is being tested

Dapagliflozin

+ Glargine

Drug
Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 30 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: July 2022
See protocol details

Summary

Principal SponsorMedanta, The Medicity, India
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 29, 2022

Actual date on which the first participant was enrolled.

This clinical trial aims to investigate the effectiveness and safety of a diabetes medication called Dapagliflozin in managing blood sugar levels for hospitalized patients with Type 2 Diabetes. The standard care for these patients typically involves multiple insulin injections throughout the day. Dapagliflozin, which belongs to a class of drugs known as Sodium-Glucose Cotransporter 2 (SGLT-2) inhibitors, has shown promise in reducing cardiovascular mortality and improving kidney outcomes. This study hopes to provide valuable information on how well Dapagliflozin can control blood sugar levels and prevent complications in hospitalized patients with Type 2 Diabetes. During the trial, participants will be divided into two groups. One group will receive Dapagliflozin in addition to their regular insulin regimen, while the other group will continue with their insulin regimen only. Blood sugar levels will be measured four times a day: before breakfast, lunch, and dinner, and at night. The primary outcome of the study is to determine if the addition of Dapagliflozin results in similar blood sugar control compared to insulin alone, without increasing the risk of complications such as low blood sugar (hypoglycemia). The study will last for 12 days, covering the first 7 days of therapy in the hospital and 5 days post-discharge.

Official TitleEfficacy and Safety of Dapagliflozin for the Hospital Management of Patients With Type 2 Diabetes: a Prospective, Open-label, Non-inferiority Randomized Trial
NCT05457933
Principal SponsorMedanta, The Medicity, India
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 30 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial Ischemia

Criteria

4 inclusion criteria required to participate
Males or females 30 years or above admitted to the hospital for elective CABG surgery
A known history of type 2 diabetes treated with any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy.
Study participants must have a randomization total daily dose (TDD) insulin requirement of at least 12 units per day.
Signed, informed consent prior to any study procedures
14 exclusion criteria prevent from participating
Subjects with increased BG concentration, but without a known history of diabetes (stress hyperglycemia).
Subjects treated with diet alone (no antidiabetic agents) and admission HbA1c <7%.
Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.
Patients treated with long-acting weekly GLP1-RA (weekly exenatide, or dulaglutide).
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Group II

Active Comparator
Glargine insulin; 300 Units/mL, average dose: 10-20 U/day; Insulin lispro 100 Units/mL, average dose: 10-30 U/day

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Division Of Endocrinology and Diabetes, Medanta The Medicity

Gurgaon, IndiaOpen Division Of Endocrinology and Diabetes, Medanta The Medicity in Google Maps
CompletedOne Study Center