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

NCT05457933 | Completed Phase 4 DMC

• 1 other identifier: MMDAPHS01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type2diabetes; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Noninferiority in mean differences between groups in their daily blood glucose concentrations

  Blood glucose will be measured pre-breakfast, pre-lunch, pre-dinner and night-time (0300 hours). Mean daily blood glucose concentration will be calculated to determine differences in inpatient glycemic control in patients with type 2 diabetes treated with dapagliflozin 10 mg plus basal-bolus insulin or basal-bolus regimen, using glargine U300 as basal insulin and insulin lispro U100 before meals.

  The first 7 days of therapy in hospital and 5 days post-discharge

Secondary Outcomes (16)

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

  The first 7 days of therapy in hospital and 5 days post-discharge.

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

  The first 7 days of therapy in hospital and 5 days post-discharge.

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

  The first 7 days of therapy in hospital and 5 days post-discharge

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

  The first 7 days of therapy in hospital and 5 days post-discharge.

• 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 and 5 days post-discharge.

Study Arms (2)

Dapagliflozin group

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

Drug: Dapagliflozin

Basal-bolus group

ACTIVE COMPARATOR

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

Drug: Glargine

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

Dapagliflozin group

Glargine DRUG

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

Also known as: Lispro

Basal-bolus group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• Any known hypersensitivity to dapagliflozin.
• History of recurrent urinary tract infections (\>2 episodes) requiring antibiotic therapy in the last 1 year.
• History of intolerance to dapagliflozin or any other sodium-glucose cotransporter 2 inhibitors.
• Patients with history of clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension).
• Patients with ongoing corticosteroid therapy (equal to a prednisone dose ≥5 mg/day).
• Patients with impaired renal function (eGFR \<45 ml/min/1.73m2).
• Patients with congestive heart failure (NYHA- IV).
• Patients with medical and surgical pancreatic disease.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Body mass index (BMI) \<18.5 kg/m2.

Sponsors & Collaborators

• Medanta, The Medicity, India: lead

Study Sites (1)

Division Of Endocrinology and Diabetes, Medanta The Medicity

Gurgaon, Haryana, 122001, India

Location

Related Publications (3)

• Pasquel FJ, Lansang MC, Dhatariya K, Umpierrez GE. Management of diabetes and hyperglycaemia in the hospital. Lancet Diabetes Endocrinol. 2021 Mar;9(3):174-188. doi: 10.1016/S2213-8587(20)30381-8. Epub 2021 Jan 27.

  PMID: 33515493 BACKGROUND

• Damman K, Beusekamp JC, Boorsma EM, Swart HP, Smilde TDJ, Elvan A, van Eck JWM, Heerspink HJL, Voors AA. Randomized, double-blind, placebo-controlled, multicentre pilot study on the effects of empagliflozin on clinical outcomes in patients with acute decompensated heart failure (EMPA-RESPONSE-AHF). Eur J Heart Fail. 2020 Apr;22(4):713-722. doi: 10.1002/ejhf.1713. Epub 2020 Jan 7.

  PMID: 31912605 RESULT

• 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 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

dapagliflozin; Insulin Glargine; Insulin Lispro

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 14, 2022
• Study Start: July 29, 2022
• Primary Completion: January 14, 2023
• Study Completion: January 14, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

IN (1)