A Comparison of Two Initial Dosing Formulas
This study will evaluate two methods of starting basal insulin to see which method may achieve a faster-to-goal titration.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Comparison of Two Initial Dosing Formulas for Basal Insulin in Type 2 Diabetes Mellitus|
- Days to reach the titration target [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]The number of days for the subject to reach the titration target blood sugar of 110 ml/dl
- The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Drug: Insulin detemir
Subjects will be randomized to weight based method of 0.1 U/kg for basal insulin or a starting dose based upon an insulin challenge. Subject will record morning fasting blood sugar daily. Using a three day average, the subject will titrate the dose of basal insulin either increasing or lowering by three units based upon target blood glucose of 110 mg/dl.
The current recommended starting dose of basal insulin in type 2 diabetes is either a fixed dose, e.g. 10 U, or a weight-based formulas, 0.1-0.2 U/kg. The estimate of eventual titration dose to attempt to reach a fasting glucose goal is 0.49 U/kg. Those many weeks of dosage upward titration are required. The investigators propose to compare the current recommended weight based, 0.1 U/kg to a correction factor derived formula. Starting with an insulin tolerance test estimation of basal dose, one would arrive at the eventual titrated basal insulin dose in significantly less days than starting at a starting dose estimate of 0.1 U/kg. Further, there would be no significant increase in overall reported hypoglycemia.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377155
|United States, California|
|Diabetes Care Center|
|Salinas, California, United States, 93901|
|Principal Investigator:||Allen B King, MD||Diabetes Care Center|