Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes

Non-inferiority Trial Comparing Insulin Glulisine to Insulin Lispro as Part of a Basal-bolus Insulin Regimen for the 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