Continuous glucose monitoring with Humalog Mix 25 versus Humalog Mix 50, twice daily: a comparative pilot study -results from the Jikei-EValuation of insulin Lispro mixture on pharmacodynamics and glycemic VariancE (J-EVOLVE) study.
OBJECTIVE
To evaluate glycemic variability associated with two different premixed insulin analogue formulations when used in a twice-daily regimen.


METHODS
Subjects comprised type 2 diabetic patients aged 20-79 years, treated with twice daily premixed insulin or insulin analogue formulations. All subjects were hospitalized for 6 days and randomized to receive either Humalog Mix 25 (Mix 25) or Humalog Mix 50 (Mix 50). They were then crossed over to the other arm between day 3 and day 4 of the study. Continuous glucose monitoring (CGM) was performed on all subjects to examine the differences in glycemic variability.


RESULTS
Eleven type 2 diabetic patients were enrolled. No significant difference was found in 24-hour mean glucose values and their SDs, pre-meal glucose values, increases from pre-meal to peak glucose values, or time to peak glucose levels between either group. However, the mean glucose values observed during 0-8 hrs were significantly lower with Mix 25 compared to Mix 50 (128 vs. 147 mg/dL; p = 0.024).


CONCLUSIONS
The twice-daily Mix 25 regimen provided superior overnight glycemic control compared to the Mix 50 regimen in Japanese patients with type 2 diabetes. However, both twice-daily regimens with either Mix 25 or Mix 50 provided inadequate post-lunch glycemic control.


BACKGROUND
Current Controlled Trials UMIN000001327.
Nishimura
Rimei
R
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan. rimei@jikei.ac.jp
Tsujino
Daisuke
D
Taki
Kentaro
K
Morimoto
Aya
A
Tajima
Naoko
N
D000328:Adult; D000368:Aged; D044466:Asian People; D015415:Biomarkers / Q000097:blood; D061265:Biphasic Insulins; D001786:Blood Glucose / Q000187:drug effects*; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000208:ethnology; D004334:Drug Administration Schedule; D002149:Energy Intake; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D061268:Insulin Lispro; D007336:Insulin, Isophane; D007564:Japan; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory; D010865:Pilot Projects; D019518:Postprandial Period; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D015415:Biomarkers; D061265:Biphasic Insulins; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D061268:Insulin Lispro; D007336:Insulin, Isophane; C517652:hemoglobin A1c protein, human; C482266:insulin lispro, isophane insulin lispro drug combination (25:75); C557537:isophane insulin, insulin lispro drug combination 50:50