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

• Status: Completed
• Trial end date: 2015-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sansum Diabetes Research Institute; William Sansum Diabetes Center
• Collaborator: Sanofi
• Treatments: Insulin; Insulin glulisine; Insulin Lispro; Insulin, Globin Zinc; Insulin, Long-Acting; Isophane Insulin, Human

Criteria

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