Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes
Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes
We hypothesize that insulin glulisine is non-inferior to currently proven rapid-acting
 insulin lispro when used in a basal/bolus regimen to treat hyperglycemia in patients with
 gestational diabetes mellitus.
To date, only two rapid-acting insulin analogs have been shown to be safe and effective for
 the treatment of diabetes during pregnancy: insulin aspart and insulin lispro.

 The pharmacokinetics and pharmacodynamics of insulin glulisine are unique and insulin
 glulisine may be the best rapid-acting analog for the treatment of post-prandial
 hyperglycemia. We believe that insulin glulisine should be evaluated in women with
 gestational diabetes for its potential efficacy.
Inclusion Criteria:

 -  Informed Consent to participate in clinical trial

 -  Pregnant and 20-30 weeks gestation

 -  Diagnosed with gestational diabetes

 -  Failed diet therapy (failed lifestyle modification will be defined as 10% or greater
 SMBG values above pre-meal <90mg/dL and post prandial < 120mg/dL

 -  Eat at least 2 meals per day

 Exclusion Criteria:

 -  Pregnant women <18 years old

 -  Blood pressure > 140/80 mmHg

 -  A1C equal to or greater than 6.5% at time of enrollment

 -  Pre-pregnancy BMI > 40Kg/m squared

 -  Evidence of any fetal anomaly on any fetal ultrasound

 -  Currently using hypoglycemic agent

 -  Refusal to use insulin before meals

 -  Inability to understand instructions or to consent to participate

 -  Pregnant women with history of T1DM or T2DM

 -  Clinical judgment by investigator that patient is inappropriate for clinical trial or
 has a metabolic disorder that could interfere with results