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

Completed · Phase 2

Conditions studied: Diabetes During Pregnancy

In brief

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.

Key facts

Study ID

NCT01662921

Run by

Sansum Diabetes Research Institute

People needed

17

Starts

2013-04-01

Expected to finish

2015-08-31

Last updated by the study team

2018-04-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• William Sansum Diabetes Center — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

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