Degludec Glargine U300 Hospital Study

NCT05036876 | Completed DMC

• 1 other identifier: MMDHS01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Limited data exist about the use of insulin degludec and insulin glargine U300 in the hospitalized patients. A previous study compared the safety and efficacy of insulin degludec versus insulin glargine U100 for the management of hospitalized patients with type 2 diabetes. However, there is no data comparing the efficacy and safety of insulin degludec versus insulin glargine U300 for the management of hospitalized patients with type 2 diabetes. Accordingly, the proposed study will provide a clinically useful information on the efficacy (blood glucose control) and safety (hypoglycemia) of insulin degludec versus insulin glargine U300 for the management of hospitalized patients with type 2 diabetes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in mean daily blood glucose concentration in hospitalized patients

  Blood glucose will be measured before each meal, bedtime and at 3:00 am. Mean daily blood glucose concentration will be calculated to determine differences in inpatient glycemic control in patients with type 2 diabetes treated with basal bolus regimen or basal plus regimen with insulin degludec or glargine U-300 once daily plus aspart insulin before meals.

  The first 7 days of therapy

Secondary Outcomes (6)

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

  The first 7 days of therapy

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

  The first 7 days of therapy

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

  The first 7 days of therapy

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

  The first 7 days of therapy

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

  The first 7 days of therapy

Study Arms (2)

Degludec

EXPERIMENTAL

Study participants with type 2 diabetes undergoing elective coronary artery bypass graft (CABG) surgery will receive 100% of the total daily dose (TDD) given as a basal bolus regimen with degludec once daily plus rapid-acting insulin glulisine before meals. Degludec insulin 100 Units/mL, average dose: 30-40 U/day; Insulin glulisine 100 Units/mL, average dose: 20-40 U/day

Drug: Degludec

Glargine U300

ACTIVE COMPARATOR

Study participants with type 2 diabetes undergoing CABG surgery will receive 100% of the total daily dose (TDD) given as a basal bolus regimen with glargine U300 once daily plus rapid-acting insulin glulisine before meals. Glargine U300;300 Units/mL, average dose: 30-40 U/day; Insulin glulisine 100 Units/mL, average dose: 20-40 U/day

Drug: Glargine U300

Interventions

Degludec DRUG

Treatment with insulin degludec when compared to insulin glargine U-300 will result in similar blood glucose control in hospitalized patients with type 2 diabetes.

Degludec

Glargine U300 DRUG

Treatment with insulin glargine U300 when compared to insulin degludec will result in similar blood glucose control in hospitalized patients with type 2 diabetes.

Glargine U300

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 except for degludec and glargine U300.
• Study participants must have a randomization total daily dose (TDD) insulin requirement of at least 20 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 degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, or dulaglutide).
• Patients with history of clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), ongoing corticosteroid therapy (equal to a prednisone dose ≥5 mg/day), or impaired renal function (eGFR\< 30 ml/min), or 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.
• Known or suspected allergy to trial medication(s), excipients, or related products.

Sponsors & Collaborators

• Medanta, The Medicity, India: lead

Study Sites (1)

Division Of Endocrinology and Diabetes , Medanta The Medicity Hospital

Gurgaon, Haryana, 122001, India

Location

Related Publications (4)

• Umpierrez GE, Hor T, Smiley D, Temponi A, Umpierrez D, Ceron M, Munoz C, Newton C, Peng L, Baldwin D. Comparison of inpatient insulin regimens with detemir plus aspart versus neutral protamine hagedorn plus regular in medical patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 Feb;94(2):564-9. doi: 10.1210/jc.2008-1441. Epub 2008 Nov 18.

  PMID: 19017758 RESULT

• Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12.

  PMID: 21228246 RESULT

• 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 RESULT

• Umpierrez GE, Smiley D, Hermayer K, Khan A, Olson DE, Newton C, Jacobs S, Rizzo M, Peng L, Reyes D, Pinzon I, Fereira ME, Hunt V, Gore A, Toyoshima MT, Fonseca VA. Randomized study comparing a Basal-bolus with a basal plus correction insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes: basal plus trial. Diabetes Care. 2013 Aug;36(8):2169-74. doi: 10.2337/dc12-1988. Epub 2013 Feb 22.

  PMID: 23435159 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

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

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: August 27, 2021
• First Posted: September 8, 2021
• Study Start: October 10, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IN (1)