Phase 4
N=114
Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency
Type 2 Diabetes · Renal Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00911625 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Average Blood Glucose Over 6 Days — 174; 174.5 milligrams per deciliter — p=.958
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 0.5 units/kg daily insulin (Drug); 0.25 units/kg daily insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Loyola University
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Blood Glucose Over 6 Days |
174; 174.5 | .958 |
| SECONDARY The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter |
15; 9; 35; 48 | .0828 |
Summary
It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction algorithm with glargine/glulisine based on weight with reduction for decreased estimated GFR by MDRD as follows: < 30 ml/min/1.73m2 or on dialysis reduce dose by 50% from weight based calculation.
Eligibility Criteria
Inclusion Criteria
- Type 2 Diabetes Mellitus of mor than 1year
- GFR less than 30 ml/min/1.73m2 or dialysis
- Age greater than 18years
- Entry blood glucose (fasting or random) greater than 180mg%
Exclusion Criteria
- Type 1 Diabetes Mellitus
- New onset hyperglycemia
- Pregnant
- Solid organ transplant within 1 year
- Steroids prednisone greater than 7.5mg/day or equivalent
- Hospital LOS predicted less than 2 days
- Severe liver disease
- Known hypopituitarism or adrenal insufficiency
- Patients in the ICU
- Patients with hypoglycemic unawareness
- Outpatient insulin dose less than 0.6 units/kg
Data sourced from ClinicalTrials.gov (NCT00911625). 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.