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
Overview
- Phase
- Phase 4
- Intervention
- Degludec
- Conditions
- Type 2 Diabetes
- Sponsor
- Emory University
- Enrollment
- 180
- Locations
- 4
- Primary Endpoint
- Mean Daily Blood Glucose Concentration in Discharged Patients.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Guillermo Umpierrez
Professor
Emory University
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
Arms & Interventions
Degludec inpatient
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.
Intervention: Degludec
Degludec inpatient
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.
Intervention: Aspart
Glargine U100 inpatient
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.
Intervention: Glargine
Glargine U100 inpatient
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.
Intervention: Aspart
Outcomes
Primary Outcomes
Mean Daily Blood Glucose Concentration in Discharged Patients.
Time Frame: Day after hospital discharge to 4 weeks after discharge, 4 to 12 weeks after hospital discharge
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.
Mean Daily Blood Glucose Concentration in Hospitalized Patients
Time Frame: Baseline, up to the first 10 days of therapy
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.
Secondary Outcomes
- 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)
- Daily Dose of Insulin in Hospitalized Patients(During the first 10 days of therapy)
- 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)
- Hemoglobin A1c (HbA1c) in Discharged Patients(4 and 12 weeks after hospital discharge)
- Number of Hypoglycemia Episodes in Discharged Patients(Up to 12 weeks after hospital discharge)
- Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients(Up to 12 weeks after hospital discharge)
- Number of Episodes of Severe Hyperglycemia in Discharged Patients(Up to 12 weeks after hospital discharge)