Glargine U300 Hospital Trial

NCT ID: NCT03013985

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-17
• Study Completion Date: 2019-03-22

Brief Summary

The purpose of this study is to find out if treatment with Glargine U300 when compared to Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D), who are admitted to the hospital and then transition at home, after discharge from the hospital.

Detailed Description

Several randomized clinical trials done previously in medicine and surgical patients with T2D have shown that basal bolus regimen with glargine results in a lower mean daily blood glucose (BG) concentrations compared to the sole use of sliding scale regular insulin (SSI) and in lower rate of hospital complications. Glargine U300 results in similar improvement but in lower rate of hypoglycemia than treatment with glargine U100. No previous studies; however, have compared the efficacy and safety of glargine U300 in the management of hyperglycemia and diabetes in the hospital setting. This study will determine if treatment with glargine U300 has a similar glucose control in patients with diabetes admitted to the hospital and if glargine U300 will result in lower number of low blood sugars compared to glargine U100 .

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Basal bolus insulin with glargine U300 and glulisine insulin

Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U300 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose described above will be given. Half of TDD will be given as glargine U300 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.

Group Type: EXPERIMENTAL

Glargine U300

Intervention Type: DRUG

Glargine U300 is a new generation long-acting insulin.

Glulisine Insulin

Intervention Type: DRUG

Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.

Basal bolus insulin with glargine U100 and glulisine insulin

Subjects treated with insulin prior to admission will receive 80% of the total daily dose (TDD) given as basal bolus insulin regimen with glargine U100 once daily plus rapid-acting glulisine insulin before meals. In insulin-naïve subjects treated with oral agents, the oral antidiabetic drugs will be discontinued and the bolus insulin dose as described above will be given. Half of TDD will be given as glargine U100 and half as glulisine. To prevent hypoglycemia, if a subject is not able to eat, the dose of glulisine will be held.

Group Type: ACTIVE_COMPARATOR

Glargine U100

Intervention Type: DRUG

Glargine U100 is a long-acting insulin.

Glulisine Insulin

Intervention Type: DRUG

Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.

Interventions

Glargine U300

Glargine U300 is a new generation long-acting insulin.

Intervention Type: DRUG

Glargine U100

Glargine U100 is a long-acting insulin.

Intervention Type: DRUG

Glulisine Insulin

Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.

Intervention Type: DRUG

Other Intervention Names

Toujeo; Lantus; Apidra

Eligibility Criteria

Inclusion Criteria

• Males or females between > 18 years admitted to a general medicine or surgical service.
• Known histories of T2D treated with either diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy with the exception of degludec and glargine U300.
• Subjects must have an admission/randomization BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones).

Exclusion Criteria

• Subjects with increased BG concentration, but without a known history of diabetes.
• Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, dulaglutide or albiglutide).
• Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.
• Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (eGFR< 30 ml/min).
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Female subjects who are pregnant or breast feeding at time of enrollment into the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

Pasquel FJ, Lansang MC, Khowaja A, Urrutia MA, Cardona S, Albury B, Galindo RJ, Fayfman M, Davis G, Migdal A, Vellanki P, Peng L, Umpierrez GE. A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial. Diabetes Care. 2020 Jun;43(6):1242-1248. doi: 10.2337/dc19-1940. Epub 2020 Apr 9.

Reference Type: DERIVED

PMID: 32273271 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00091740

Identifier Type: -

Identifier Source: org_study_id