Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/11/2015 |
| Start Date: | April 2013 |
| End Date: | October 2017 |
| Contact: | Lois Jovanovic, MD |
| Email: | ljovanovic@sansum.org |
| Phone: | 805-682-7638 |
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
