Insulin Degludec and Glargine U100 for Management of Hospitalized and Discharged Patients With Type 2 Diabetes

NCT03336528 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00087816
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to find out if treatment with degludec insulin when compared to glargine U100 insulin will result in similar blood sugar control in patients with diabetes who are admitted to the hospital and then transition to home after discharge from the hospital.

Conditions

Type 2 Diabetes

Keywords

Long-acting insulin analog

Outcome Measures

Primary Outcomes (2)

• Mean Daily Blood Glucose Concentration in Hospitalized Patients

  Blood glucose was measured before each meal and at bedtime among hospitalized study participants. Mean daily blood glucose concentration was calculated to determine differences in inpatient glycemic control in general medicine and surgery patients with Type 2 Diabetes (T2D) treated with basal bolus regimen with insulin degludec or glargine once daily plus aspart insulin before meals. A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.

  Baseline, up to the first 10 days of therapy

• Mean Daily Blood Glucose Concentration in Discharged Patients.

  Blood glucose was measured before each meal and at bedtime, after participants were discharged from the hospital. Mean daily blood glucose concentration was calculated to determine differences in outpatient glycemic control in patients with Type 2 Diabetes (T2D) treated with basal bolus regimen with insulin degludec or glargine once daily plus aspart insulin before meals. Information was collected via bi-weekly phone interviews and during the outpatient study visits at Weeks 4 and 12.

  Day after hospital discharge to 4 weeks after discharge, 4 to 12 weeks after hospital discharge

Secondary Outcomes (10)

• Number of Blood Glucose Point-of-care Test Results Between 70 and 180 mg/dL in Hospitalized Patients

  During the first 10 days of therapy

• Number of Participants With an Episode of Hypoglycemia While Hospitalized

  During the first 10 days of therapy

• Number of Participants With an Episode of Clinically Significant Hypoglycemia While Hospitalized

  During the first 10 days of therapy

• Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized

  During the first 10 days of therapy

• Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized

  During the first 10 days of therapy

Other Outcomes (5)

• Number of Participants Experiencing Cardiac Complications During Hospitalization

  During the first 10 days of therapy

• Number of Participants With Acute Kidney Injury During Hospitalization

  During the first 10 days of therapy

• Length of Hospital Stay

  Duration of hospital stay (an average of 10 days)

Study Arms (2)

Degludec inpatient

EXPERIMENTAL

Study participants treated with insulin prior to admission will receive 80% or 100% of the total daily dose (TDD) given as a basal bolus regimen with degludec once daily plus rapid-acting aspart insulin before meals.

Drug: Degludec; Drug: Aspart

Glargine U100 inpatient

ACTIVE COMPARATOR

Study participants treated with insulin prior to admission will receive 80% or 100% of the total daily dose (TDD) given as basal bolus regimen with glargine once daily plus rapid-acting aspart insulin before meals.

Drug: Glargine; Drug: Aspart

Interventions

Degludec DRUG

Degludec is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Patients will be treated with bolus regimen given half of total daily dose (TDD) as basal once daily and half as aspart divided in three equal doses before meals. Patients with poor oral intake or with medical instruction to withhold oral intake (NPO) will receive the basal dose, but prandial dose will be held. Insulin dose will be adjusted daily to maintain a fasting and pre-dinner blood glucose (BG) between 100 mg/dL and 180 mg/dL.

Also known as: Tresiba

Degludec inpatient

Glargine DRUG

Glargine is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Patients will be treated with bolus regimen given half of total daily dose (TDD) as basal once daily and half as aspart divided in three equal doses before meals. Patients with poor oral intake or with medical instruction to withhold oral intake (NPO) will receive the basal dose, but prandial dose will be held. Insulin dose will be adjusted daily to maintain a fasting and pre-dinner BG between 100 mg/dL and 180 mg/dL.

Also known as: Lantus

Glargine U100 inpatient

Aspart DRUG

Aspart insulin will be given in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, aspart insulin dose will be held.

Also known as: Novolog

Degludec inpatient; Glargine U100 inpatient

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 \> 18 years of age who are admitted to a general medicine or surgical service
• A known history of T2D treated either with diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting glucagon-like peptide-1 receptor agonists (GLP-1 RA) or insulin therapy except for degludec and glargine U300
• Subjects with diet alone and HbA1c\>7.0%
• Medical and surgical patients expected to be admitted length of stay (LOS) longer than 2 days
• Subjects must have a randomization BG \> 140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate \< 18 milliequivalent (mEq)/L, potential of hydrogen (pH) \< 7.30, or positive serum or urinary ketones)
• Signed, informed consent and HIPAA documentation 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%
• Admission or pre-randomization BG≥400 mg/dL
• 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 GLP-1 RA (weekly exenatide, dulaglutide or albiglutide)
• Patients with acute critical or surgical illness admitted to the ICU except for observation (\<24 hours and did not require vasopressors and/or mechanical ventilation)
• 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)
• 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
• Known or suspected allergy to trial medication(s), excipients, or related products
• Previous participation in this trial

Sponsors & Collaborators

• Emory University: lead
• Novo Nordisk A/S: collaborator

Study Sites (4)

Grady Hospital

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital Clinical Research Network

Atlanta, Georgia, 30322, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Providence Medical Research Centre

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• Galindo RJ, Pasquel FJ, Vellanki P, Alicic R, Lam DW, Fayfman M, Migdal AL, Davis GM, Cardona S, Urrutia MA, Perez-Guzman C, Zamudio-Coronado KW, Peng L, Tuttle KR, Umpierrez GE. Degludec hospital trial: A randomized controlled trial comparing insulin degludec U100 and glargine U100 for the inpatient management of patients with type 2 diabetes. Diabetes Obes Metab. 2022 Jan;24(1):42-49. doi: 10.1111/dom.14544. Epub 2021 Sep 24.

  PMID: 34490700 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec; Insulin Glargine; Insulin Aspart

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; Insulin, Short-Acting

Results Point of Contact

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

geumpie@emory.edu

(404) 778-1663

Study Officials

• Guillermo Umpierrez, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: November 6, 2017
• First Posted: November 8, 2017
• Study Start: January 2, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 31, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available for sharing starting 6 months after publication and up to 5 years after publication.
• Access Criteria: Access will be given to researchers who provide a methodologically sound proposal to achieve the aims in their approved proposal. Proposals should be directed to geumpie@emory.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (4)