Phase 4
N=74
Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)
Diabetic Ketoacidosis
Bottom Line
View on ClinicalTrials.gov: NCT00590044 ↗Enrolled (actual)
74
Serious AEs
4.1%
Results posted
Apr 2009
Primary outcome: Primary: Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups — 8; 26 number of hypoglycemia episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- insulin glargine+ glulisine (Drug); NPH + Regular insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups |
8; 26 | — |
| SECONDARY Mean Daily Blood Glucose Concentration Between the Two Groups After the Resolution of Ketoacidosis and Transition to Subcutaneous Insulin |
213; 188; 220; 206; 180; 207 | — |
| SECONDARY Mean Blood Glucose Concentration in mg/dL While on the Insulin Drip Among the 2 Groups |
153; 185 | — |
| SECONDARY Difference in Time in Hours to Resolution of DKA Between the 2 Groups |
8.9; 10.5 | — |
Summary
The study is a multicenter, randomized controlled trial to compare the safety and efficacy of insulin analogs and human insulins both during acute intravenous treatment and during the transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).
Eligibility Criteria
Inclusion Criteria
- All patients admitted to Grady Memorial Hospital who meet diagnosis criteria of DKA and who are willing to participate in the study protocol will be considered candidates for inclusion into the study.
- Diagnostic Criteria for DKA: Blood glucose > 250 mg/dL, arterial or venous phenol hydroxylase (pH) 3 mmol).
Exclusion Criteria
- Hemodynamic instability (MAP 3.0 mg/dl); end stage liver failure, and cirrhosis.
- Patients with dementia or persistent altered mental status that would prevent collection of consent form and reliable information.
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00590044). 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.