Phase 4
N=224
Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02408120 ↗Enrolled (actual)
224
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Mean Daily BG Levels — 172; 173 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin glargine (Drug); Insulin aspart (Drug); Supplemental insulin aspart (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daily BG Levels |
172; 173 | — |
| SECONDARY Mean Blood Glucose Levels Before Lunch |
160; 172 | — |
| SECONDARY Mean Blood Glucose Levels at Bedtime |
157; 171 | — |
| SECONDARY Mean Blood Glucose Levels Before Dinner |
151; 160 | — |
| SECONDARY Number of Hypoglycemia Events |
16; 15 | — |
| SECONDARY Incidence of Hyperglycemia |
45; 42 | — |
| SECONDARY Number of Blood Glucose Readings Within 100-140 mg/dL Range |
59; 57 | — |
| SECONDARY Average Number of Days of Hospital Stay |
4; 4 | — |
| SECONDARY Mortality |
1; 0 | — |
| SECONDARY Number of Subjects That Experienced Hospital Complications |
11; 12 | — |
| SECONDARY Mean Daily Dose of Insulin |
47; 41 | — |
Summary
The purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. Studies done in the past indicate that blood sugar levels are controlled on the standard treatment of insulin and that most patients do not need the small extra dose of insulin at bedtime. The investigators want to test if there is any benefit to giving patients extra doses of insulin during the day to correct the high blood sugars.
Eligibility Criteria
Inclusion Criteria
- Subjects admitted to the hospital with acute or chronic medical illnesses or for elective and emergency surgical illness or trauma
- Known history of Type 2 diabetes mellitus for >3 months
- Treated with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy
- Blood glucose levels between >140 mg and <400 mg/dL without laboratory evidence of diabetic ketoacidosis
Exclusion Criteria
- Hyperglycemia without a history of diabetes
- Subjects with acute critical illness admitted to the ICU or expected to require ICU admission
- Subjects receiving continuous insulin infusion
- Clinically relevant hepatic disease
- Corticosteroid therapy
- Serum creatinine ≥ 3.5 mg/dL and/or glomerular filtration rate (GFR) <30
- Subjects unable to sign consent
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02408120). 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.