Phase 4
Completed N=180
Insulin Degludec and Glargine U100 for Management of Hospitalized and Discharged Patients With Type 2 Diabetes
Type 2 Diabetes
Source: ClinicalTrials.gov NCT03336528 ↗
Enrolled (actual)
180
Serious AEs
3.7%
Results posted
Mar 2022
Primary outcomePrimary: Mean Daily Blood Glucose Concentration in Hospitalized Patients — 219.50; 218.19; 179.75; 180.67 mg/dL
◆ Published Evidence
Established
25citations · ~6 / year
Degludec hospital trial: A randomized controlled trial comparing insulin degludec U100 and glargine U100 for the inpatient management of patients with type 2 diabetes.
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.
Linked Publications
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Degludec hospital trial: A randomized controlled trial comparing insulin degludec U100 and glargine U100 for the inpatient management of patients with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daily Blood Glucose Concentration in Hospitalized Patients |
219.50; 218.19; 179.75; 180.67 | — |
| PRIMARY Mean Daily Blood Glucose Concentration in Discharged Patients. |
157.0; 143.0; 148.7; 133.8 | — |
| SECONDARY Number of Blood Glucose Point-of-care Test Results Between 70 and 180 mg/dL in Hospitalized Patients |
758; 789 | — |
| SECONDARY Number of Participants With an Episode of Hypoglycemia While Hospitalized |
14; 15 | — |
| SECONDARY Number of Participants With an Episode of Clinically Significant Hypoglycemia While Hospitalized |
3; 1 | — |
| SECONDARY Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized |
0; 0 | — |
| SECONDARY Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized |
52; 47 | — |
| SECONDARY Daily Dose of Insulin in Hospitalized Patients |
30; 30; 11; 12; 56; 60 | — |
| SECONDARY Hemoglobin A1c (HbA1c) in Discharged Patients |
8.3; 8.0; 8.2; 7.4 | — |
| SECONDARY Number of Hypoglycemia Episodes in Discharged Patients |
16; 19 | — |
| SECONDARY Number of Clinically Significant Hypoglycemia Episodes in Discharged Patients |
1; 1 | — |
| SECONDARY Number of Episodes of Severe Hyperglycemia in Discharged Patients |
211; 55 | — |
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
Data sourced from ClinicalTrials.gov (NCT03336528) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.