Back to results

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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Degludec

Glargine

Aspart

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Long-acting insulin analog

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Grady Hospital
Emory University Hospital Clinical Research Network
Mount Sinai
Providence Medical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Degludec inpatient

Glargine U100 inpatient

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

Blood glucose was measured with point-of-care testing before each meal and at bedtime, and the count of blood glucose test results between 70 mg/dL and 180 mg/dL was determined.

Number of Participants With an Episode of Hypoglycemia While Hospitalized

Blood glucose (BG) was measured before each meal and at bedtime. The number of participants with at least one hypoglycemic episode, defined as BG of 54 to 70 mg/dL, is presented here.

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

Blood glucose was measured before each meal and at bedtime. The number of participants with at least one episode of clinically significant hypoglycemia, defined as BG < 54 mg/dL, is presented here.

Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized

Blood glucose as measured before each meal and at bedtime. The number of participants with at least one episode of severe hypoglycemia, defined as BG < 40 mg/dL, is presented here.

Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized

Blood glucose was measured before each meal and at bedtime. The number of participants who experienced at least one episode of severe hyperglycemia, defined as BG > 240 mg/dL, is presented here.

Daily Dose of Insulin in Hospitalized Patients

Electronic medical records and nursing records documented the day day and time of insulin administration, including the basal study drug given once daily (degludec or glargine), prandial insulin given before meals (aspart), and supplemental insulin given to correct hyperglycemia. The mean daily doses of basal insulin, prandial insulin, and total daily dose of insulin given to hospitalized patients are presented here.

Hemoglobin A1c (HbA1c) in Discharged Patients

The HbA1C test reflects the average of a person's blood glucose levels over the past 3 months by measuring the percentage of red blood cells (RBCs) with glycated hemoglobin (hemoglobin with glucose bonded to it). Participants with HbA1C ≥ 7.5% were followed for 12 weeks after hospital discharge. Samples for HbA1C were drawn at 4 and 12 weeks post-discharge. An HbA1c measurement below 5.7% is considered normal, while a measurement of 6.5% or greater indicates diabetes.

Number of Hypoglycemia Episodes in Discharged Patients

Blood glucose was measured before each meal and at bedtime. The number of hypoglycemia episodes, defined as BG < 70 mg/dL, was recorded via bi-weekly phone interviews and during 4 and 12 week outpatient study visits.

Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients

Blood glucose will be measured before each meal and at bedtime. The number of episodes of clinically significant hypoglycemia, defined as BG < 54 mg/dL, are presented here.

Number of Episodes of Severe Hyperglycemia in Discharged Patients

Blood glucose was measured before each meal and at bedtime. The number of episodes of severe hyperglycemia, defined as BG > 240 mg/dL, are presented here.

Full Information

NCT ID

NCT03336528

First Posted

November 6, 2017

Last Updated

March 25, 2022

Sponsor

Emory University

Collaborators

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03336528

Brief Title

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

Official Title

A Randomized Controlled Trial Comparing Insulin Degludec and Glargine U100 for the Inpatient and Post-Hospital Discharge Management of Medicine and Surgery Patients With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

January 2, 2018 (Actual)

Primary Completion Date

March 1, 2021 (Actual)

Study Completion Date

March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Degludec is a new generation basal insulin analog with a longer duration of action compared to insulin glargine. Several outpatient trials have reported that treatment with degludec results in comparable improvement in HbA1c levels and in lower rates of hypoglycemia compared to glargine U100 insulin. However, no previous studies have compared the safety and efficacy of the long-acting basal insulin degludec in the inpatient management of patients with diabetes. It is expected that a large number of patients with diabetes will be started on or transitioned to this new insulin formulation so acquiring knowledge on the safety and efficacy of degludec insulin is of great clinical interest. Accordingly, the proposed study will provide novel and clinically useful information on the efficacy (assessed as blood glucose control) and safety (assessed as hypoglycemia) of degludec in the inpatient setting and after hospital discharge in general medicine and surgery patients with Type 2 Diabetes (T2D). Participants will be randomized to receive either a basal bolus with degludec or glargine U100 once daily during hospitalization. All participants will receive aspart insulin before meals. Participants with poorly controlled diabetes during the inpatient portion of the study will be invited to participate in the outpatient portion of the study. Participants in the outpatient portion of the study will be discharged on their preadmission oral antidiabetic medications plus degludec or glargine once daily, based on the study medication they were randomized to take during the inpatient portion of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Long-acting insulin analog

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Degludec inpatient

Arm Type

Experimental

Arm Description

Arm Title

Glargine U100 inpatient

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Degludec

Other Intervention Name(s)

Tresiba

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Glargine

Other Intervention Name(s)

Lantus

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Aspart

Other Intervention Name(s)

Novolog

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean Daily Blood Glucose Concentration in Hospitalized Patients

Description

Time Frame

Baseline, up to the first 10 days of therapy

Title

Mean Daily Blood Glucose Concentration in Discharged Patients.

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Blood glucose was measured with point-of-care testing before each meal and at bedtime, and the count of blood glucose test results between 70 mg/dL and 180 mg/dL was determined.

Time Frame

During the first 10 days of therapy

Title

Number of Participants With an Episode of Hypoglycemia While Hospitalized

Description

Blood glucose (BG) was measured before each meal and at bedtime. The number of participants with at least one hypoglycemic episode, defined as BG of 54 to 70 mg/dL, is presented here.

Time Frame

During the first 10 days of therapy

Title

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

Description

Blood glucose was measured before each meal and at bedtime. The number of participants with at least one episode of clinically significant hypoglycemia, defined as BG < 54 mg/dL, is presented here.

Time Frame

During the first 10 days of therapy

Title

Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized

Description

Blood glucose as measured before each meal and at bedtime. The number of participants with at least one episode of severe hypoglycemia, defined as BG < 40 mg/dL, is presented here.

Time Frame

During the first 10 days of therapy

Title

Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized

Description

Blood glucose was measured before each meal and at bedtime. The number of participants who experienced at least one episode of severe hyperglycemia, defined as BG > 240 mg/dL, is presented here.

Time Frame

During the first 10 days of therapy

Title

Daily Dose of Insulin in Hospitalized Patients

Description

Time Frame

During the first 10 days of therapy

Title

Hemoglobin A1c (HbA1c) in Discharged Patients

Description

Time Frame

4 and 12 weeks after hospital discharge

Title

Number of Hypoglycemia Episodes in Discharged Patients

Description

Time Frame

Up to 12 weeks after hospital discharge

Title

Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients

Description

Blood glucose will be measured before each meal and at bedtime. The number of episodes of clinically significant hypoglycemia, defined as BG < 54 mg/dL, are presented here.

Time Frame

Up to 12 weeks after hospital discharge

Title

Number of Episodes of Severe Hyperglycemia in Discharged Patients

Description

Blood glucose was measured before each meal and at bedtime. The number of episodes of severe hyperglycemia, defined as BG > 240 mg/dL, are presented here.

Time Frame

Up to 12 weeks after hospital discharge

Other Pre-specified Outcome Measures:

Title

Number of Participants Experiencing Cardiac Complications During Hospitalization

Description

Cardiac complications during hospitalization were examined as a composite of complications, defined as myocardial infarction, cardiac arrhythmia requiring medical treatment, or cardiac arrest. The number of participants experiencing cardiac complications while hospitalized patients is presented here.

Time Frame

During the first 10 days of therapy

Title

Number of Participants With Acute Kidney Injury During Hospitalization

Description

Acute kidney injury defined as an increase in serum creatinine ≥ 0.3 mg/dL from baseline or ≥1.5 times baseline creatinine, per Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. The number of participants experiencing acute kidney injury during hospitalization is presented here.

Time Frame

During the first 10 days of therapy

Title

Length of Hospital Stay

Description

The length of hospital in days is presented here.

Time Frame

Duration of hospital stay (an average of 10 days)

Title

Number of Participants Who Died During Hospitalization

Description

Hospital mortality is evaluated as the number of deaths among participants during hospitalization.

Time Frame

Duration of hospital stay (an average of 10 days)

Title

Number of Participants Experiencing Acute Kidney Injury in Discharged Patients

Description

Time Frame

Up to 12 weeks after hospital discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guillermo Umpierrez, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Grady Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Emory University Hospital Clinical Research Network

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Providence Medical Research Centre

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The research team will share individual participant data that underlie the results reported in this study, after deidentification.

IPD Sharing Time Frame

Data will be available for sharing starting 6 months after publication and up to 5 years after publication.

IPD Sharing 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.

Citations:

PubMed Identifier

34490700

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs