Diabetes During Pregnancy
Conditions
Keywords
bolus treatment
Brief 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.
Detailed description
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.
Interventions
DRUGNPH
Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age
DRUGInsulin LISPRO
Insulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days
DRUGInsulin glulisine
Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days
Sponsors
Sanofi
Sansum Diabetes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus | week 4 of insulin treatment | compare average 1-hour post prandial SMBG measurements between patients randomized to insulin glulisine or insulin lispro |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge | week 2 of insulin treatment | patients will come to the study site under fasting conditions and eat a standardized meal in the morning post administration of insulin NPH and their randomized bolus insulin. |
| Compare A1C at enrollment and weekly until delivery | up to 36 weeks | A1C is measured weekly at each pregnancy visit up to 26 visits. Subjects are enrolled at 20-32 weeks gestation and have weekly visits to obtain A1C through delivery, and again at the 6-week postpartum visit. |
| Compare incidence of hypoglycemic episodes <60 mg/dL with symptoms | up to 36 weeks | Hypoglycemic episodes since the last visit will be reported at each pregnancy visit, usually weekly, from enrollment at 10-30 weeks gestation through delivery and at the 6-week postpartum visit if continuing to take insulin. |
Other
| Measure | Time frame |
|---|---|
| Compare incidence of birth weight >90th percentile | delivery |
| Compare incidence of primary cesarean section | delivery |
Countries
United States
Outcome results
None listed