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

CompletedPhase 2

Sponsor: Sansum Diabetes Research Institute

Conditions: Diabetes During Pregnancy

Interventions: NPH, Insulin LISPRO, Insulin glulisine

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Santa Barbara, California, United States