Phase 4
Completed N=211
Glargine U300 Hospital Trial
Source: ClinicalTrials.gov NCT03013985 ↗Enrolled (actual)
211
Serious AEs
19.9%
Results posted
May 2020
Primary outcomePrimary: Mean Daily Blood Glucose Concentration Inpatient — 186; 184 mg/dL
◆ Published Evidence
Established
47citations · ~8 / year
A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial.
Summary
The purpose of this study is to find out if treatment with Glargine U300 when compared to Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D), who are admitted to the hospital and then transition at home, after discharge from the hospital.
Linked Publications
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A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daily Blood Glucose Concentration Inpatient |
186; 184 | — |
| PRIMARY Mean Daily Blood Glucose Concentration After Hospital Discharge |
171.6; 164.5 | — |
| SECONDARY Mean Daily Glucose in Patients With Admission HbA1c Lower Than 8% |
150; 134.4 | — |
| SECONDARY Mean Daily Glucose in Patients With Admission HbA1c Higher Than 8% |
152.3; 155.6 | — |
| SECONDARY Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days |
169.71; 196.72 | — |
| SECONDARY Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days |
193.53; 193.64 | — |
| SECONDARY Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days |
188.46; 174.55 | — |
| SECONDARY Percent of Blood Glucose 70-180 Measured by Point of Care Test |
50.3; 54.9 | — |
| SECONDARY Percent of Subjects With Hypoglycemic Events |
8.7; 9.5 | — |
| SECONDARY Percent of Subjects With Severe Hypoglycemia |
0; 6 | — |
| SECONDARY Number of Days of Hospital Stay |
6; 4 | — |
| SECONDARY Number Subjects With Cardiac Complications |
5; 11 | — |
| SECONDARY Number of Patients With Acute Renal Failure |
1; 1 | — |
| SECONDARY Hospital Mortality |
0; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females between > 18 years admitted to a general medicine or surgical service.
- Known histories of T2D treated with either diet alone, oral monotherapy, any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy with the exception of degludec and glargine U300.
- Subjects must have an admission/randomization BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 mEq/L, pH < 7.30, or positive serum or urinary ketones).
Exclusion Criteria
- Subjects with increased BG concentration, but without a known history of diabetes.
- Patients treated with degludec or glargine U300, or with long-acting weekly GLP1-RA (weekly exenatide, dulaglutide or albiglutide).
- Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.
- Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (eGFR< 30 ml/min).
- 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.
Data sourced from ClinicalTrials.gov (NCT03013985) 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.