Phase 4
N=130
Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00590226 ↗Enrolled (actual)
130
Serious AEs
21.5%
Results posted
Jun 2014
Primary outcome: Primary: Mean AM BG (mg/dl) — 144; 155 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Detemir + aspart insulin before meals (Drug); NPH insulin + regular insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean AM BG (mg/dl) |
144; 155 | — |
| SECONDARY Number of Patients With Hypoglycemic Events |
15; 13 | — |
Summary
High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. Recently, the use of basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart, glulisine) has been shown to facilitate outpatient glycemic control with lower rate of hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will determine the efficacy and safety of the combination of detemir and aspart insulin in the inpatient management of subjects with diabetes. We hypothesize that in patients with type 2 diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic events than treatment with twice a day NPH plus regular insulin before meals. Detemir is a long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Detemir and aspart insulins are approved for use in the treatment of patients with diabetes by the FDA.
This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. Dr. Umpierrez designed the study and will serve as principal investigator. A total of 65 patients will be recruited at Grady and 65 patients at the Rush University Medical Center, Chicago, IL.
Eligibility Criteria
Inclusion Criteria
- Males or females between the ages of 18 and 70 years admitted to a general medical service.
- A known history of type 2 diabetes mellitus > 3 months, receiving any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) and/or insulin therapy.
- Subjects must have an admission blood glucose > 140 mg and upper limit of normal), or impaired renal function, as shown by a serum creatinine ≥2.0 mg/dL for males, or ≥ 1.8 mg/dL for females.
- History of drug or alcohol abuse within the last 2 years.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism.
- Female subjects are pregnant or breast feeding at time of enrollment into the study.
Data sourced from ClinicalTrials.gov (NCT00590226). 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.