N/A
Completed N=63
Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM
Diabetes Mellitus (DM)
Source: ClinicalTrials.gov NCT01855243 ↗
Enrolled (actual)
63
Serious AEs
3.2%
Results posted
Jan 2019
Primary outcomePrimary: Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay. — 221; 179; 222 mg/dL
Summary
Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens for glycemic control in hospitalized diabetic patients with diabetes.
Methods: In a prospective trial, patients with diabetes will be randomized to receive either traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥ 150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay. |
221; 179; 222 | — |
| PRIMARY Mean BG After First Day of Hospitalization |
225; 171; 218 | — |
| SECONDARY Number of Patients Developed Hypoglycemic Events |
3; 0; 1; 2; 0; 0 | — |
| SECONDARY Number of Patients Developed Episodes of Severe Hyperglycemia |
10; 4; 15 | — |
| SECONDARY Mortality Rate |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- known history of type 2 DM for longer than 3 months
- age between 18-64 year old,
- treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission.
Exclusion Criteria
- subjects with hyperglycemia without any known history of DM
- presence of diabetic ketoacidosis (DKA)
- patients admitted to intensive care unit (ICU)
- subjects expected to undergo surgery during the hospitalization course
- patients with clinically relevant hepatic disease impaired renal function (serum creatinine ≥ 3.0 mg/dL) systemic infections pregnancy patients on medications known to interfere with the blood glucose level (either increasing or decreasing
Data sourced from ClinicalTrials.gov (NCT01855243). 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.