Clinical trial NCT03336528: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Long-acting insulin analog
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2017-11-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Males or females \> 18 years of age who are admitted to a general medicine or surgical service
2. 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
3. Subjects with diet alone and HbA1c\>7.0%
4. Medical and surgical patients expected to be admitted length of stay (LOS) longer than 2 days
5. 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)
6. Signed, informed consent and HIPAA documentation prior to any study procedures

Exclusion Criteria:

1. Subjects with increased BG concentration, but without a known history of diabetes (stress hyperglycemia)
2. Subjects treated with diet alone (no antidiabetic agents) and admission HbA1c \<7%
3. Admission or pre-randomization BG≥400 mg/dL
4. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria
5. Patients treated with degludec or glargine U300, or with long-acting weekly GLP-1 RA (weekly exenatide, dulaglutide or albiglutide)
6. 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)
7. 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)
8. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
9. Female subjects who are pregnant or breast feeding at time of enrollment into the study
10. Known or suspected allergy to trial medication(s), excipients, or related products
11. Previous participation in this trial

Primary outcomes:
measure: Mean Daily Blood Glucose Concentration in Hospitalized Patients
timeFrame: Baseline, up to the first 10 days of therapy
measure: Mean Daily Blood Glucose Concentration in Discharged Patients.
timeFrame: Day after hospital discharge to 4 weeks after discharge, 4 to 12 weeks after hospital discharge
Secondary outcomes:
measure: Number of Blood Glucose Point-of-care Test Results Between 70 and 180 mg/dL in Hospitalized Patients
timeFrame: During the first 10 days of therapy
measure: Number of Participants With an Episode of Hypoglycemia While Hospitalized
timeFrame: During the first 10 days of therapy
measure: Number of Participants With an Episode of Clinically Significant Hypoglycemia While Hospitalized
timeFrame: During the first 10 days of therapy
measure: Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized
timeFrame: During the first 10 days of therapy
measure: Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized
timeFrame: During the first 10 days of therapy
measure: Daily Dose of Insulin in Hospitalized Patients
timeFrame: During the first 10 days of therapy
measure: Hemoglobin A1c (HbA1c) in Discharged Patients
timeFrame: 4 and 12 weeks after hospital discharge
measure: Number of Hypoglycemia Episodes in Discharged Patients
timeFrame: Up to 12 weeks after hospital discharge
measure: Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients
timeFrame: Up to 12 weeks after hospital discharge
measure: Number of Episodes of Severe Hyperglycemia in Discharged Patients
timeFrame: Up to 12 weeks after hospital discharge
Other outcomes:
measure: Number of Participants Experiencing Cardiac Complications During Hospitalization
timeFrame: During the first 10 days of therapy
measure: Number of Participants With Acute Kidney Injury During Hospitalization
timeFrame: During the first 10 days of therapy
measure: Length of Hospital Stay
timeFrame: Duration of hospital stay (an average of 10 days)
measure: Number of Participants Who Died During Hospitalization
timeFrame: Duration of hospital stay (an average of 10 days)
measure: Number of Participants Experiencing Acute Kidney Injury in Discharged Patients
timeFrame: Up to 12 weeks after hospital discharge
Locations:
city: Atlanta
country: United States
facility: Grady Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Clinical Research Network
state: Georgia
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Spokane
country: United States
facility: Providence Medical Research Centre
state: Washington
Study officials:
affiliation: Emory University
name: Guillermo Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.