Glargine U300 Hospital Trial

NCT03013985 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00091740
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 4

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.

Conditions

Type 2 Diabetes

Keywords

Blood glucose

Outcome Measures

Primary Outcomes (2)

• Mean Daily Blood Glucose Concentration Inpatient

  The mean daily blood glucose concentration for all participants will be calculated by taking the average of all pre-meal and bedtime glucose values collected each day after the first day of therapy during the hospital stay.

  up to 10 days (day of hospital discharge)

• Mean Daily Blood Glucose Concentration After Hospital Discharge

  Subjects will measure their blood sugar levels at home by finger stick before meals two or three times per day and record the readings in a diary. The readings will be averaged for each day and the mean daily blood glucose concentration will be calculated.

  assessed from day 11 (day after hospital discharge) up to 3 months

Secondary Outcomes (12)

• Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8%

  up to 3 months post enrollment

• Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8%

  up to 3 months post enrollment

• Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days

  Up to 3 days

• Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days

  Up to 5 days

• Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days

  Up to 10 days

Study Arms (2)

Basal bolus insulin with glargine U300 and glulisine insulin

EXPERIMENTAL

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.

Drug: Glargine U300; Drug: Glulisine Insulin

Basal bolus insulin with glargine U100 and glulisine insulin

ACTIVE COMPARATOR

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.

Drug: Glargine U100; Drug: Glulisine Insulin

Interventions

Glargine U300 DRUG

Glargine U300 is a new generation long-acting insulin.

Also known as: Toujeo

Basal bolus insulin with glargine U300 and glulisine insulin

Glargine U100 DRUG

Glargine U100 is a long-acting insulin.

Also known as: Lantus

Basal bolus insulin with glargine U100 and glulisine insulin

Glulisine Insulin DRUG

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

Also known as: Apidra

Basal bolus insulin with glargine U100 and glulisine insulin; Basal bolus insulin with glargine U300 and glulisine insulin

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (4)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 32273271 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; insulin glulisine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Guillermo Umpierrez
• Organization: Emory University

GEUMPIE@emory.edu

404-778-1665

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Professor

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 9, 2017
• Study Start: May 17, 2017
• Primary Completion: March 22, 2019
• Study Completion: March 22, 2019
• Last Updated: May 7, 2020
• Results First Posted: May 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)