A Phase 4 interventional study of Degludec and Glargine in Type 2 Diabetes, sponsored by Emory University. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Emory University · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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
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
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
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
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
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.
Time frame: 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.
Time frame: Day after hospital discharge to 4 weeks after discharge, 4 to 12 weeks after hospital discharge
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.
Time frame: During the first 10 days of therapy
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.
Time frame: During the first 10 days of therapy
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.
Time frame: During the first 10 days of therapy
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.
Time frame: During the first 10 days of therapy
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.
Time frame: During the first 10 days of therapy
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.
Time frame: During the first 10 days of therapy
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.
Time frame: 4 and 12 weeks after hospital discharge
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.
Time frame: Up to 12 weeks after hospital discharge
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.
Time frame: Up to 12 weeks after hospital discharge
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.
Time frame: Up to 12 weeks after hospital discharge
Number of Participants Experiencing Cardiac Complications During Hospitalization
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
Number of Participants With Acute Kidney Injury During Hospitalization
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
Length of Hospital Stay
The length of hospital in days is presented here.
Time frame: Duration of hospital stay (an average of 10 days)
Number of Participants Who Died During Hospitalization
Hospital mortality is evaluated as the number of deaths among participants during hospitalization.
Time frame: Duration of hospital stay (an average of 10 days)
Number of Participants Experiencing Acute Kidney Injury in Discharged Patients
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 after hospital discharge is presented here.
Time frame: Up to 12 weeks after hospital discharge
Participants were recruited from four study sites in the United States: Emory University Hospital and Grady Memorial Hospital in Atlanta, Georgia, Icahn School of Medicine at Mount Sinai in New York, New York, and Providence Medical Research Center in Spokane, Washington. Enrollment began on January 2, 2018 and all follow up was complete by March 1, 2021.
| Milestone | Degludec | Glargine |
|---|---|---|
| Started | 92 | 88 |
| Participated in optional outpatient study | 72 | 59 |
| Completed | 82 | 79 |
| Not completed | 10 | 9 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Discharged within 48 hours of study medication | 8 | 6 |
| Withdrew: Did not receive study medication | 1 | 2 |
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.
| mg/dL | Degludec | Glargine |
|---|---|---|
| Baseline | 219.50 ± 50.21 | 218.19 ± 54.56 |
| Day 1 up to Day 10 | 179.75 ± 38.45 | 180.67 ± 45.10 |
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.
| mg/dL | Degludec During Hospitalization | Glargine During Hospitalization |
|---|---|---|
| Day after discharge up to the 4 week post-discharge study visit | 157.0 ± 46.4 | 143.0 ± 42.5 |
| 4 week post-discharge up to the 12 week post-discharge study visit | 148.7 ± 43.6 | 133.8 ± 44.2 |
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.
| Blood Glucose Point-of-Care Test | Degludec | Glargine |
|---|---|---|
| Number of Blood Glucose Point-of-care Test Results Between 70 and 180 mg/dL in Hospitalized Patients | 758 | 789 |
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.
| Participants | Degludec | Glargine |
|---|---|---|
| Number of Participants With an Episode of Hypoglycemia While Hospitalized | 14 | 15 |
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.
| Participants | Degludec | Glargine |
|---|---|---|
| Number of Participants With an Episode of Clinically Significant Hypoglycemia While Hospitalized | 3 | 1 |
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.
| Participants | Degludec | Glargine |
|---|---|---|
| Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized | 0 | 0 |
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.
| Participants | Degludec | Glargine |
|---|---|---|
| Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized | 52 | 47 |
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.
| International Units of insulin | Degludec | Glargine |
|---|---|---|
| Basal Insulin | 30 ± 13 | 30 ± 18 |
| Prandial Insulin | 11 ± 9 | 12 ± 11 |
| Total Daily Dose of Insulin | 56 ± 24 | 60 ± 36 |
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.
| percent of RBCs with glycated hemoglobin | Degludec | Glargine |
|---|---|---|
| 4 weeks post-discharge | 8.3 ± 1.4 | 8.0 ± 1.4 |
| 12 weeks post-discharge | 8.2 ± 1.9 | 7.4 ± 1.6 |
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.
| episodes of hypoglycemia | Degludec | Glargine |
|---|---|---|
| Number of Hypoglycemia Episodes in Discharged Patients | 16 | 19 |
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.
| episodes of significant hypoglycemia | Degludec | Glargine |
|---|---|---|
| Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients | 1 | 1 |
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.
| episodes of severe hyperglycemia | Degludec | Glargine |
|---|---|---|
| Number of Episodes of Severe Hyperglycemia in Discharged Patients | 211 | 55 |
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.
| Participants | Degludec | Glargine |
|---|---|---|
| Number of Participants Experiencing Cardiac Complications During Hospitalization | 0 | 0 |
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.
| Participants | Degludec | Glargine |
|---|---|---|
| Number of Participants With Acute Kidney Injury During Hospitalization | 5 | 10 |
The length of hospital in days is presented here.
| days | Degludec | Glargine |
|---|---|---|
| Length of Hospital Stay | 6.7 (4.7 to 10.5) | 7.5 (4.7 to 11.6) |
Hospital mortality is evaluated as the number of deaths among participants during hospitalization.
| Participants | Degludec | Glargine |
|---|---|---|
| Number of Participants Who Died During Hospitalization | 0 | 1 |
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 after hospital discharge is presented here.
| Participants | Degludec | Glargine |
|---|---|---|
| Number of Participants Experiencing Acute Kidney Injury in Discharged Patients | 1 | 0 |
Collected over Information on adverse events was collected from the time of consent during hospitalization for up to 3 months after hospital discharge.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Degludec | 1/82 (1.2%) | 3/82 (3.7%) | 3/82 (3.7%) |
| Glargine | 1/79 (1.3%) | 3/79 (3.8%) | 3/79 (3.8%) |
| Event | Degludec | Glargine |
|---|---|---|
| Hospital readmission for chest painCardiac disorders | 0/82 | 1/79 |
| Hospital readmission for urinary tract infectionRenal and urinary disorders | 0/82 | 1/79 |
| Hospital readmission for head injuryNervous system disorders | 0/82 | 1/79 |
| Hospital readmisson for non-healing amputation stumpInfections and infestations | 1/82 | 0/79 |
| Hospital readmission for heart failureCardiac disorders | 1/82 | 0/79 |
| Severe hypoglycemiaEndocrine disorders | 1/82 | 0/79 |
| Event | Degludec | Glargine |
|---|---|---|
| Emergency room visit for blunt chest traumaMusculoskeletal and connective tissue disorders | 0/82 | 1/79 |
| Emergency room visit for right eye medial styeEye disorders | 0/82 | 1/79 |
| Emergency room visit for orthostatic hypotensionCardiac disorders | 0/82 | 1/79 |
| Emergency room visit for bilateral knee painMusculoskeletal and connective tissue disorders | 1/82 | 0/79 |
| Emergency room visit for wound infectionInfections and infestations | 1/82 | 0/79 |
| Emergency room visit for congestive heart failureCardiac disorders | 1/82 | 0/79 |
The baseline analysis population includes participants who completed the inpatient portion of the study and had at least two doses of the study medication.
| Age, Continuous(Years) | Degludec | Glargine | Total |
|---|---|---|---|
| Mean | 55.6 ± 12 | 56.7 ± 10 | 56.2 ± 11 |
| Sex: Female, Male(Participants) | Degludec | Glargine | Total |
|---|---|---|---|
| Female | 35 | 25 | 60 |
| Male | 47 | 54 | 101 |
| Ethnicity (NIH/OMB)(Participants) | Degludec | Glargine | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 10 | 18 |
| Not Hispanic or Latino | 74 | 69 | 143 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Degludec | Glargine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 58 | 56 | 114 |
| White | 16 | 18 | 34 |
| More than one race | 7 | 5 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Degludec | Glargine | Total |
|---|---|---|---|
| United States | 82 | 79 | 161 |
| Body Mass Index(kg/m^2) | Degludec | Glargine | Total |
|---|---|---|---|
| Mean | 36 ± 9 | 36 ± 12 | 36 ± 11 |
| Home diabetes treatment(Participants) | Degludec | Glargine | Total |
|---|---|---|---|
| No treatment | 7 | 10 | 17 |
| Oral diabetic agents | 18 | 15 | 33 |
| Insulin only | 30 | 32 | 62 |
| Insulin plus oral diabetic agent | 27 | 21 | 48 |
| Glucagon-like peptide-1 receptor agonists (GLP-1RA) | 0 | 1 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The research team will share individual participant data that underlie the results reported in this study, after deidentification.
Supporting information: Study protocol, Sap
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Emory University