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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-inferiority Trial Comparing Insulin Glulisine to Insulin Lispro as Part of a Basal-bolus Insulin Regimen for the Treatment of Gestational Diabetes.

Conditions
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Diabetes During Pregnancy

Intervention / Treatment
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* Drug: NPH
* Drug: Insulin LISPRO
* Drug: Insulin glulisine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NPH and insulin lispro<br>Patients diagnosed with diabetes during pregnancy will be randomized to long acting insulin NPH and short acting insulin lispro in a basal bolus regimen to treat post prandial hyperglycemia using a dosing schedule of 50% NPH calculated by the patients weight and gestational age and 50% lispro pending their last three SMPG average. | Drug: NPH<br>* Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age<br>* Other names: Humulin N, Novolin N;Drug: Insulin LISPRO<br>* Insulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days<br>* Other names: Humalog;|
| Active Comparator: NPH and insulin glulisine<br>Patients with a diagnosis of diabetes during pregnancy will be randomized to using long acting insulin NPH and short acting insulin glulisine as treatment for post prandial hyperglycemia with a 50% NPH dosing schedule based on the weight and gestational age and 50% glulisine schedule based on their last three SMBG result average. | Drug: NPH<br>* Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age<br>* Other names: Humulin N, Novolin N;Drug: Insulin glulisine<br>* Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days<br>* Other names: Apidra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| show that insulin glulisine is non-inferior to insulin lispro in a basal/bolus regimen to treat hyperglycemia in patient with gestational diabetes mellitus | compare average 1-hour post prandial SMBG measurements between patients randomized to insulin glulisine or insulin lispro | week 4 of insulin treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum blood glucose area under the curve (AUC) at one 4-hour in-clinic meal challenge | 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. | week 2 of insulin treatment | 
| Compare A1C at enrollment and weekly until delivery | 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. | up to 36 weeks | 
| Compare incidence of hypoglycemic episodes <60 mg/dL with symptoms | 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. | up to 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bolus treatment